<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03278613</url>
  </required_header>
  <id_info>
    <org_study_id>12865-29</org_study_id>
    <secondary_id>2U24HD069031-06</secondary_id>
    <secondary_id>2UG1HD069013-06</secondary_id>
    <secondary_id>5UG1HD041267-18</secondary_id>
    <secondary_id>5UG1HD069010-07</secondary_id>
    <secondary_id>5UG1HD069006-07</secondary_id>
    <secondary_id>5UG1HD041261-17</secondary_id>
    <secondary_id>5UG1HD054214-12</secondary_id>
    <secondary_id>5UG1HD054241-12</secondary_id>
    <nct_id>NCT03278613</nct_id>
  </id_info>
  <brief_title>Neuromodulation for Accidental Bowel Leakage</brief_title>
  <acronym>NOTABLe</acronym>
  <official_title>Neuromodulation for Accidental Bowel Leakage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NICHD Pelvic Floor Disorders Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Women and Infants Hospital of Rhode Island</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>RTI International</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NICHD Pelvic Floor Disorders Network</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a multi-center, randomized clinical trial of women with refractory accidental&#xD;
      bowel leakage (ABL) symptoms who have failed to achieve satisfactory symptom control from 2&#xD;
      first-line treatments for ABL: supervised pelvic muscle training (PMT) and constipating&#xD;
      medication. The purpose of this study is to compare percutaneous tibial nerve stimulation&#xD;
      (PTNS) to a validated sham to determine if PTNS is effective for the treatment of fecal&#xD;
      incontinence (FI) in women.&#xD;
&#xD;
      The investigators will test the null hypothesis that change from baseline in St. Mark's&#xD;
      (Vaizey) score after 12 weeks of stimulation is not significantly different in women with&#xD;
      symptomatic ABL receiving PTNS treatments compared to women receiving sham PTNS treatments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overarching goal of this randomized clinical trial is to determine if PTNS is more&#xD;
      effective than sham PTNS for the treatment of FI in women after 12 weeks of treatment and 1&#xD;
      year after initiating treatment. This is a two-part trial with a Run-In Phase prior to&#xD;
      randomization. The trial has the following primary aim:&#xD;
&#xD;
      To determine whether the change from baseline in St. Mark's (Vaizey) score in women with&#xD;
      symptomatic ABL undergoing PTNS differs from sham after 12 weeks of stimulation.&#xD;
&#xD;
      Additional secondary aims include:&#xD;
&#xD;
        1. To compare changes from baseline in self-reported functional outcomes after 12 weekly&#xD;
           stimulation sessions in both PTNS and sham groups in Part 1.&#xD;
&#xD;
        2. To determine whether symptom relief amongst study &quot;responders&quot; can be sustained for one&#xD;
           year with maintenance treatments in Part II.&#xD;
&#xD;
        3. To determine the impact of completing a bowel diary and receiving education on FI on&#xD;
           symptom severity.&#xD;
&#xD;
        4. To determine the ability of the PFDN ABL phone app bowel diary to detect changes from&#xD;
           baseline in fecal incontinence episodes recorded to after 12 weeks of stimulation&#xD;
           sessions.&#xD;
&#xD;
        5. To determine the association between St. Mark's score and both fat and fiber intake&#xD;
           alone and in combination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 9, 2018</start_date>
  <completion_date type="Actual">March 9, 2020</completion_date>
  <primary_completion_date type="Actual">March 9, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants will remain masked to subject treatment assignment throughout the trial. To maintain masking of participants, the duration of treatment sessions for both the PTNS and sham groups will be 30 minutes and will be conducted with subjects in a supine position with the knees comfortably abducted and flexed. The leg and foot involved in treatment will be obscured from the subject's view with a portable anesthesia drape frame to which an exam sheet will be secured.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline St. Mark's (Vaizey) Score</measure>
    <time_frame>4, 8, and 12 Weeks</time_frame>
    <description>The primary outcome measure is the change from baseline in St. Mark's (Vaizey) Score 12 weeks after treatment initiation to compare the outcomes of post-tibial nerve stimulation (PTNS) versus sham stimulation. The St. Mark's (Vaizey) score, published in 1999, is commonly used in clinical studies and reports and was based on the Jorge-Wexner score but added two further items for assessment: the use of constipating medication and the presence of fecal urgency. Minimum score is 0 = perfect continence; maximum score is 24 = totally incontinent. Change from baseline is calculated as Week [4, 8, or 12] Score minus the score at baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Responder to Treatment</measure>
    <time_frame>4, 8, and 12 Weeks</time_frame>
    <description>Responder status is based on the primary chnage from St. Mark's Score. A responder is defined as any particpant with at least a 4 point reduction in score compared to their baseline score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Number of Fecal Incontinence Events Per Week</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of fecal incontinence episodes per week at 8 and 12 weeks and the number of fecal incontinence episodes at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Number of Urge Fecal Incontinence Events Per Week</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of urge fecal incontinence episodes per week at 8 and 12 weeks and the number of urge fecal incontinence episodes at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Number of Bowel Movements Per Week</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of bowel movements per week at 8 and 12 weeks and the number of bowel movements at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Number of Urge Bowel Movements Per Week</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of urge bowel movements per week at 8 and 12 weeks and the number of urge bowel movements at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Number of Days Without Fecal Incontinence Episodes Per Week</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of days without fecal incontinence episodes per week at 8 and 12 weeks and the number of days without fecal incontinence episodes at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>50% Improvement in Fecal Incontinence Episodes Per Week</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome is calculated as any participant with a 50% reduction in fecal incontinence episodes per week at 8 and 12 weeks compared to the fecal incontinence episodes at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>75% Improvement in Fecal Incontinence Episodes Per Week</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome is calculated as any participant with a 75% reduction in fecal incontinence episodes per week at 8, and 12 weeks compared to the fecal incontinence episodes at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression-Improvement</measure>
    <time_frame>4, 8, and 12 Weeks</time_frame>
    <description>The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better) or 2 (much better)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change From Baseline ABLe Liquid Score</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>The ABLE Liquid Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of liquid stool. Minimum score is 0 = no problem with liquid stool leakage; maximum score is 4 = frequent, bothersome leakage of large amounts of liquid stool. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline ABLe Solid Score</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>The ABLE Solid Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of solid stool. Minimum score is 0 = no problem with solid stool leakage; maximum score is 4 = frequent, bothersome leakage of large amounts of solid stool. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline ABLe Mucus Score</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>The ABLE Mucus Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of mucus from the rectum. Minimum score is 0 = no problem with mucus leakage from the rectum; maximum score is 4 = frequent, bothersome leakage of large amounts of mucus from the rectum. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline ABLe Gas Score</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>The ABLE Gas Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of gas from the rectum. Minimum score is 0 = no problem with gas leakage from the rectum; maximum score is 4 = frequent and bothersome leakage of gas from the rectum. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline ABLe Predictability/Awareness Score</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>The ABLE Predictability/Awareness Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the predictability of bowel leakage events. Minimum score is 0 = no problems with leakage; maximum score is 4 = leakage without awareness or predictability. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline ABLe Control Score</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>The ABLE Control Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the ability to control bowel movements. Minimum score is 0 = no problems with urgency to empty bowels wthout warning; maximum score is 4 = frequent and bothersome urgency to empty bowels wthout warning.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline ABLe Ancillary Bowel Symptoms Score</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>The ABLE Ancillary Bowel Symptoms Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the frequency and impact of ancially bowel symptoms. Minimum score is 0 = no problems with pain or incomplete emptying; maximum score is 4 = frequent and bothersome pain or incomplete emptying.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline ABLe Overall Score</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>The ABLE Overall Score is the summary score of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the frequency and impact of accidental bowel leakage and related symptoms. Minimum score is 0 = no problems with bowel leakage and related symptoms; maximum score is 4 = frequent and bothersome problems with bowel leakage and related symptoms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Global Symptom Control</measure>
    <time_frame>Baseline and 4, 8, and 12 Weeks</time_frame>
    <description>The Patient Global Symptom Control (PGSC) is a patient-reported measure of perceived agreement that symptoms are under control, as assessed on a scale of 1 (Disagree Strongly) to 5 (Agree Strongly). Included here are participants who had reported disagreements as indicated by a rating of 1 (Disagree Strongly) or 2 (Disagree)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline FIQL Lifestyle Score</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>The FIQL Lifestyle Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline FIQL Coping Score</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>The FIQL Coping Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline FIQL Depression Score</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>The FIQL Depression Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline FIQL Embarrassment Score</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>The FIQL Embarrassment Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline FISI Patient Score</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>The FISI Patient Score is a summary score of the validated Fecal Incontinence Severity Index questionnaire which provides a summary metric of the severity of fecal incontinence from the patient's perspective. Minimum score is 0 = no fecal incontinence; maximum score is 61 = very severe fecal incontinence. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline FISI Doctor Score</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>The FISI Doctor Score is a summary score of the validated Fecal Incontinence Severity Index questionnaire which provides a summary metric of the severity of fecal incontinence from the doctor's perspective. Minimum score is 0 = no fecal incontinence; maximum score is 57 = very severe fecal incontinence. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline MMHQ Incontinence Impact Score</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>The MMHQ Incontinence Impact Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline MMHQ Role Limitations Score</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>The MMHQ Role Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline MMHQ Physical Limitations Score</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>The MMHQ Physical Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline MMHQ Social Limitations Score</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>The MMHQ Social Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline MMHQ Personal Relationship Score</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>The MMHQ Personal Relationship Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline MMHQ Emotional Function Score</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>The MMHQ Emotional Function Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline MMHQ Sleep/Energy Score</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>The MMHQ Sleep/Energy Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline MMHQ Severity Measures Score</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>The MMHQ Severity Measures Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline CRAIQ Score</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline POPIQ Score</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline UIQ Score</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline PFIQ Score</measure>
    <time_frame>8 and 12 Weeks</time_frame>
    <description>The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline PAC-SYM Abdominal Score</measure>
    <time_frame>12 Weeks</time_frame>
    <description>The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline PAC-SYM Rectal Score</measure>
    <time_frame>12 Weeks</time_frame>
    <description>The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline PAC-SYM Stool Score</measure>
    <time_frame>12 Weeks</time_frame>
    <description>The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline PAC-SYM Total Score</measure>
    <time_frame>12 Weeks</time_frame>
    <description>The Patient Assessment of Constipation - Symptom (PAC-SYM) is a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-missing responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very severe). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline PISQ-IR NSA-PR Score</measure>
    <time_frame>12 Weeks</time_frame>
    <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Partner Related (NSA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline PISQ-IR NSA-CS Score</measure>
    <time_frame>12 Weeks</time_frame>
    <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Specific (NSA-CS) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline PISQ-IR NSA-GQA Score</measure>
    <time_frame>12 Weeks</time_frame>
    <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Global Quality Rating (NSA-GQA) ranges from 1 to 4.5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline PISQ-IR NSA-CI Score</measure>
    <time_frame>12 Weeks</time_frame>
    <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Impact (NSA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline PISQ-IR SA-AO Score</measure>
    <time_frame>12 Weeks</time_frame>
    <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Arousal Orgasm (SA-AO) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline PISQ-IR SA-PR Score</measure>
    <time_frame>12 Weeks</time_frame>
    <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Partner Related (SA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline PISQ-IR SA-CS Score</measure>
    <time_frame>12 Weeks</time_frame>
    <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Specific (SA-CS) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline PISQ-IR SA-GQR Score</measure>
    <time_frame>12 Weeks</time_frame>
    <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Global Quality Rating (SA-GQR) ranges from 1 to 4.75 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline PISQ-IR SA-CI Score</measure>
    <time_frame>12 Weeks</time_frame>
    <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Impact (SA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline PISQ-IR SA-D Score</measure>
    <time_frame>12 Weeks</time_frame>
    <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Desire (SA-D) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline PISQ-IR SA-AVG Score</measure>
    <time_frame>12 Weeks</time_frame>
    <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Average (SA-AVG) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline FIAI Hygiene Index Score</measure>
    <time_frame>12 Weeks</time_frame>
    <description>The Fecal Incontinence Adaptation Index (FIAI) is a validated form which measures the adaptation behavios resulting from fecal incontinence. It consists of two subscales: Hygiene (range: 0-100) and Avoidance (range: 0-100). Scores are cal calculated as the average of the non-missing responses multiplied by 25. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline FIAI Avoidance Index Score</measure>
    <time_frame>12 Weeks</time_frame>
    <description>The Fecal Incontinence Adaptation Index (FIAI) is a validated form which measures the adaptation behavios resulting from fecal incontinence. It consists of two subscales: Hygiene (range: 0-100) and Avoidance (range: 0-100). Scores are cal calculated as the average of the non-missing responses multiplied by 25. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline SF-12 Aggregate Physical Score</measure>
    <time_frame>12 Weeks</time_frame>
    <description>The 12-Item Short-Form Health Survey (SF-12) is a validated survey which assesses overall physical and mental health. The Aggregate Physical Score ranges from 24 to 56.6 with higher scores indicating greater physical health. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline SF-12 Aggregate Mental Score</measure>
    <time_frame>12 Weeks</time_frame>
    <description>The 12-Item Short-Form Health Survey (SF-12) is a validated survey which assesses overall physical and mental health. The Aggregate Mental Score ranges from 19.06 to 60.86 with higher scores indicating greater mental health. The outcome is calculated as the difference in score at 12 weeks and the score at baseline</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">166</enrollment>
  <condition>Fecal Incontinence</condition>
  <condition>Bowel Incontinence</condition>
  <arm_group>
    <arm_group_label>Percutaneous Tibial Nerve Stimulation (PTNS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Validated Sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ES-130</intervention_name>
    <description>The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
    <arm_group_label>Percutaneous Tibial Nerve Stimulation (PTNS)</arm_group_label>
    <arm_group_label>Validated Sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women ≥ 18 years of age&#xD;
&#xD;
          -  FI symptoms ≥ 3 months&#xD;
&#xD;
          -  Baseline St. Mark's score of ≥ 12&#xD;
&#xD;
          -  Attended ≥ 2 supervised PMT for ABL&#xD;
&#xD;
          -  Intolerance, unwillingness, or inadequate response to constipating medications&#xD;
&#xD;
          -  Current negative colon cancer screening based on the USPSTF's recommendation for&#xD;
             colorectal cancer screening (2016)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous PTNS treatment&#xD;
&#xD;
          -  History of uncontrolled diarrhea in the past 3 months (usual or most common stool type&#xD;
             over the preceding 3 months of 7 on the Bristol Stool Form Scale)&#xD;
&#xD;
          -  History of severe constipation in the past 3 months (usual or most common stool type&#xD;
             over the preceding 3 months of 1 on the Bristol Stool Form Scale)&#xD;
&#xD;
          -  History of inflammatory bowel disease (includes Crohn's disease and ulcerative&#xD;
             colitis, but does not include irritable bowel disease)&#xD;
&#xD;
          -  Unrepaired rectovaginal fistula/chronic 4th degree laceration&#xD;
&#xD;
          -  Full thickness rectal prolapse&#xD;
&#xD;
          -  History of congenital anorectal malformation&#xD;
&#xD;
          -  History of bowel resection surgery for any indication&#xD;
&#xD;
          -  Minor anal procedures within 6 months for treatment of ABL (injection of bulking agent&#xD;
             or radiofrequency energy) or ligation of hemorrhoids&#xD;
&#xD;
          -  Prior pelvic or abdominal radiation&#xD;
&#xD;
          -  Diagnosis of cancer of the descending colon or anus&#xD;
&#xD;
          -  Diagnosis of cancer in the region where the PTNS or sham needles or surface electrodes&#xD;
             would be placed&#xD;
&#xD;
          -  Pacemaker, implantable defibrillator&#xD;
&#xD;
          -  Current use of Interstim sacral nerve stimulator or TENS in the pelvic region, back,&#xD;
             or legs&#xD;
&#xD;
          -  Clinically significant neurological disorders known to affect anal continence&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Severe peripheral edema preventing accurate placement of PTNS needles&#xD;
&#xD;
          -  Chronic swollen, infected, inflamed skin or skin eruptions (e.g., phlebitis,&#xD;
             thrombophlebitis, varicose veins) in the region where the PTNS or sham needles or&#xD;
             surface electrodes would be placed&#xD;
&#xD;
          -  Metal implant in foot/toes near TENS electrode location&#xD;
&#xD;
          -  Marked sensory deficit (numbness) of feet or ankles in the region where the PTNS or&#xD;
             sham needles or surface electrodes would be placed&#xD;
&#xD;
          -  Childbirth within the last 3 months&#xD;
&#xD;
          -  Pregnant or planning to become pregnant during the study duration 1 year; a urine&#xD;
             pregnancy test will be performed and must be negative by the first intervention visit&#xD;
             if the participant is of childbearing potential&#xD;
&#xD;
          -  Unwilling to use acceptable form of contraceptive if the participant is of&#xD;
             childbearing potential&#xD;
&#xD;
          -  Participation in another intervention trial impacting bowel function&#xD;
&#xD;
          -  Inability to provide informed consent, complete questionnaires independently, or to&#xD;
             attend intervention sessions&#xD;
&#xD;
          -  Unable or unwilling to complete the bowel diary in Run-In Phase (valid diary defined&#xD;
             as data from ≥ 10 of 14 days with minimum of 3 consecutive days per week)&#xD;
&#xD;
          -  Unwilling to download bowel diary app onto smartphone if the participant owns a&#xD;
             smartphone&#xD;
&#xD;
          -  Visual impairment prohibiting reading the paper diary, the smart phone screen&#xD;
&#xD;
          -  Unable to speak, read, or write in English or Spanish at a basic level&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Halina M Zyczynski, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Magee-Women's Hospital, Department of Obstetrics and Gynecology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233-7333</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente -- Downey</name>
      <address>
        <city>Downey</city>
        <state>California</state>
        <zip>90242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California at San Diego, UCSD Women's Pelvic Medicine Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037-0974</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente -- San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27707</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Magee-Women's Hospital, Department of Obstetrics and Gynecology</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <results_first_submitted>March 24, 2021</results_first_submitted>
  <results_first_submitted_qc>April 22, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 14, 2021</results_first_posted>
  <last_update_submitted>April 22, 2021</last_update_submitted>
  <last_update_submitted_qc>April 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fecal Incontinence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 3, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03278613/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 28, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03278613/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Percutaneous Tibial Nerve Stimulation (PTNS)</title>
          <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
        </group>
        <group group_id="P2">
          <title>Validated Sham</title>
          <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="111"/>
                <participants group_id="P2" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="108"/>
                <participants group_id="P2" count="54"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>PTNS</title>
          <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
        </group>
        <group group_id="B2">
          <title>Sham</title>
          <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="111"/>
            <count group_id="B2" value="55"/>
            <count group_id="B3" value="166"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.5" spread="12"/>
                    <measurement group_id="B2" value="63.8" spread="11"/>
                    <measurement group_id="B3" value="63.6" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="111"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="99"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="148"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="134"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.2" spread="7"/>
                    <measurement group_id="B2" value="29.7" spread="6"/>
                    <measurement group_id="B3" value="29.4" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Current Smoker</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ever Pregnant</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="107"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="157"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Vaginal Deliveries</title>
          <units>deliveries per participant</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2" lower_limit="0" upper_limit="9"/>
                    <measurement group_id="B2" value="2" lower_limit="0" upper_limit="7"/>
                    <measurement group_id="B3" value="2" lower_limit="0" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Cesarean Deliveries</title>
          <units>deliveries per participant</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="B2" value="0" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="B3" value="0" lower_limit="0" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Menstrual Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>pre-menopausal</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>post-menopausal</title>
                  <measurement_list>
                    <measurement group_id="B1" value="92"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="141"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not sure</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline St. Mark's (Vaizey) Score</title>
        <description>The primary outcome measure is the change from baseline in St. Mark's (Vaizey) Score 12 weeks after treatment initiation to compare the outcomes of post-tibial nerve stimulation (PTNS) versus sham stimulation. The St. Mark's (Vaizey) score, published in 1999, is commonly used in clinical studies and reports and was based on the Jorge-Wexner score but added two further items for assessment: the use of constipating medication and the presence of fecal urgency. Minimum score is 0 = perfect continence; maximum score is 24 = totally incontinent. Change from baseline is calculated as Week [4, 8, or 12] Score minus the score at baseline.</description>
        <time_frame>4, 8, and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline St. Mark's (Vaizey) Score</title>
          <description>The primary outcome measure is the change from baseline in St. Mark's (Vaizey) Score 12 weeks after treatment initiation to compare the outcomes of post-tibial nerve stimulation (PTNS) versus sham stimulation. The St. Mark's (Vaizey) score, published in 1999, is commonly used in clinical studies and reports and was based on the Jorge-Wexner score but added two further items for assessment: the use of constipating medication and the presence of fecal urgency. Minimum score is 0 = perfect continence; maximum score is 24 = totally incontinent. Change from baseline is calculated as Week [4, 8, or 12] Score minus the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.8" lower_limit="-3.5" upper_limit="-2"/>
                    <measurement group_id="O2" value="-3.3" lower_limit="-4.5" upper_limit="-2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.3" lower_limit="-5.2" upper_limit="-3.3"/>
                    <measurement group_id="O2" value="-4.1" lower_limit="-5.4" upper_limit="-2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="104"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.3" lower_limit="-6.3" upper_limit="-4.3"/>
                    <measurement group_id="O2" value="-3.9" lower_limit="-5.3" upper_limit="-2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Responder to Treatment</title>
        <description>Responder status is based on the primary chnage from St. Mark's Score. A responder is defined as any particpant with at least a 4 point reduction in score compared to their baseline score</description>
        <time_frame>4, 8, and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Responder to Treatment</title>
          <description>Responder status is based on the primary chnage from St. Mark's Score. A responder is defined as any particpant with at least a 4 point reduction in score compared to their baseline score</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Responder</title>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-responder</title>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Responder</title>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-responder</title>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="104"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Responder</title>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-responder</title>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Number of Fecal Incontinence Events Per Week</title>
        <description>Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of fecal incontinence episodes per week at 8 and 12 weeks and the number of fecal incontinence episodes at baseline.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Number of Fecal Incontinence Events Per Week</title>
          <description>Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of fecal incontinence episodes per week at 8 and 12 weeks and the number of fecal incontinence episodes at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>episodes per week</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.4" lower_limit="-3.1" upper_limit="-1.6"/>
                    <measurement group_id="O2" value="-1.6" lower_limit="-3.2" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.3" lower_limit="-3.2" upper_limit="-1.5"/>
                    <measurement group_id="O2" value="-2.1" lower_limit="-3.7" upper_limit="-0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Number of Urge Fecal Incontinence Events Per Week</title>
        <description>Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of urge fecal incontinence episodes per week at 8 and 12 weeks and the number of urge fecal incontinence episodes at baseline.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Number of Urge Fecal Incontinence Events Per Week</title>
          <description>Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of urge fecal incontinence episodes per week at 8 and 12 weeks and the number of urge fecal incontinence episodes at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>episodes per week</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" lower_limit="-1.8" upper_limit="-0.8"/>
                    <measurement group_id="O2" value="-0.4" lower_limit="-1.1" upper_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" lower_limit="-1.6" upper_limit="-0.6"/>
                    <measurement group_id="O2" value="-0.8" lower_limit="-1.4" upper_limit="-0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Number of Bowel Movements Per Week</title>
        <description>Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of bowel movements per week at 8 and 12 weeks and the number of bowel movements at baseline.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Number of Bowel Movements Per Week</title>
          <description>Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of bowel movements per week at 8 and 12 weeks and the number of bowel movements at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>episodes per week</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" lower_limit="-3" upper_limit="-0.6"/>
                    <measurement group_id="O2" value="-0.2" lower_limit="-1.6" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" lower_limit="-2.8" upper_limit="-0.9"/>
                    <measurement group_id="O2" value="-1.5" lower_limit="-2.8" upper_limit="-0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Number of Urge Bowel Movements Per Week</title>
        <description>Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of urge bowel movements per week at 8 and 12 weeks and the number of urge bowel movements at baseline.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Number of Urge Bowel Movements Per Week</title>
          <description>Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of urge bowel movements per week at 8 and 12 weeks and the number of urge bowel movements at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>episodes per week</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.9" lower_limit="-2.9" upper_limit="-0.8"/>
                    <measurement group_id="O2" value="-1.1" lower_limit="-2.2" upper_limit="-0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.3" lower_limit="-3.2" upper_limit="-1.3"/>
                    <measurement group_id="O2" value="-2.2" lower_limit="-3.3" upper_limit="-1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Number of Days Without Fecal Incontinence Episodes Per Week</title>
        <description>Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of days without fecal incontinence episodes per week at 8 and 12 weeks and the number of days without fecal incontinence episodes at baseline.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Number of Days Without Fecal Incontinence Episodes Per Week</title>
          <description>Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of days without fecal incontinence episodes per week at 8 and 12 weeks and the number of days without fecal incontinence episodes at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>episodes per week</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0.6" upper_limit="1.4"/>
                    <measurement group_id="O2" value="0.8" lower_limit="0.3" upper_limit="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" lower_limit="0.9" upper_limit="1.7"/>
                    <measurement group_id="O2" value="0.8" lower_limit="0.2" upper_limit="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>50% Improvement in Fecal Incontinence Episodes Per Week</title>
        <description>Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome is calculated as any participant with a 50% reduction in fecal incontinence episodes per week at 8 and 12 weeks compared to the fecal incontinence episodes at baseline</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>50% Improvement in Fecal Incontinence Episodes Per Week</title>
          <description>Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome is calculated as any participant with a 50% reduction in fecal incontinence episodes per week at 8 and 12 weeks compared to the fecal incontinence episodes at baseline</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&gt;= 50% Improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&lt; 50% Improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&gt;= 50% Improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&lt; 50% Improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>75% Improvement in Fecal Incontinence Episodes Per Week</title>
        <description>Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome is calculated as any participant with a 75% reduction in fecal incontinence episodes per week at 8, and 12 weeks compared to the fecal incontinence episodes at baseline.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>75% Improvement in Fecal Incontinence Episodes Per Week</title>
          <description>Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome is calculated as any participant with a 75% reduction in fecal incontinence episodes per week at 8, and 12 weeks compared to the fecal incontinence episodes at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&gt;= 75% Improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&lt; 75% Improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&gt;= 75% Improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&lt; 75% Improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Global Impression-Improvement</title>
        <description>The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better) or 2 (much better)</description>
        <time_frame>4, 8, and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Impression-Improvement</title>
          <description>The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better) or 2 (much better)</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Improved</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Improved</title>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Improved</title>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline ABLe Liquid Score</title>
        <description>The ABLE Liquid Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of liquid stool. Minimum score is 0 = no problem with liquid stool leakage; maximum score is 4 = frequent, bothersome leakage of large amounts of liquid stool. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline ABLe Liquid Score</title>
          <description>The ABLE Liquid Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of liquid stool. Minimum score is 0 = no problem with liquid stool leakage; maximum score is 4 = frequent, bothersome leakage of large amounts of liquid stool. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" lower_limit="-0.4" upper_limit="-0.1"/>
                    <measurement group_id="O2" value="-0.5" lower_limit="-0.8" upper_limit="-0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" lower_limit="-0.8" upper_limit="-0.4"/>
                    <measurement group_id="O2" value="-0.7" lower_limit="-1" upper_limit="-0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline ABLe Solid Score</title>
        <description>The ABLE Solid Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of solid stool. Minimum score is 0 = no problem with solid stool leakage; maximum score is 4 = frequent, bothersome leakage of large amounts of solid stool. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline ABLe Solid Score</title>
          <description>The ABLE Solid Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of solid stool. Minimum score is 0 = no problem with solid stool leakage; maximum score is 4 = frequent, bothersome leakage of large amounts of solid stool. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" lower_limit="-0.7" upper_limit="-0.3"/>
                    <measurement group_id="O2" value="-0.4" lower_limit="-0.6" upper_limit="-0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" lower_limit="-0.9" upper_limit="-0.5"/>
                    <measurement group_id="O2" value="-0.7" lower_limit="-1" upper_limit="-0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline ABLe Mucus Score</title>
        <description>The ABLE Mucus Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of mucus from the rectum. Minimum score is 0 = no problem with mucus leakage from the rectum; maximum score is 4 = frequent, bothersome leakage of large amounts of mucus from the rectum. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline ABLe Mucus Score</title>
          <description>The ABLE Mucus Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of mucus from the rectum. Minimum score is 0 = no problem with mucus leakage from the rectum; maximum score is 4 = frequent, bothersome leakage of large amounts of mucus from the rectum. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="104"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" lower_limit="-0.7" upper_limit="-0.3"/>
                    <measurement group_id="O2" value="-0.4" lower_limit="-0.7" upper_limit="-0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" lower_limit="-0.9" upper_limit="-0.5"/>
                    <measurement group_id="O2" value="-0.4" lower_limit="-0.7" upper_limit="-0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline ABLe Gas Score</title>
        <description>The ABLE Gas Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of gas from the rectum. Minimum score is 0 = no problem with gas leakage from the rectum; maximum score is 4 = frequent and bothersome leakage of gas from the rectum. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline ABLe Gas Score</title>
          <description>The ABLE Gas Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of gas from the rectum. Minimum score is 0 = no problem with gas leakage from the rectum; maximum score is 4 = frequent and bothersome leakage of gas from the rectum. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" lower_limit="-0.5" upper_limit="-0.1"/>
                    <measurement group_id="O2" value="-0.2" lower_limit="-0.5" upper_limit="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" lower_limit="-0.6" upper_limit="-0.3"/>
                    <measurement group_id="O2" value="-0.4" lower_limit="-0.7" upper_limit="-0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline ABLe Predictability/Awareness Score</title>
        <description>The ABLE Predictability/Awareness Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the predictability of bowel leakage events. Minimum score is 0 = no problems with leakage; maximum score is 4 = leakage without awareness or predictability. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline ABLe Predictability/Awareness Score</title>
          <description>The ABLE Predictability/Awareness Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the predictability of bowel leakage events. Minimum score is 0 = no problems with leakage; maximum score is 4 = leakage without awareness or predictability. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="-0.2" upper_limit="0.1"/>
                    <measurement group_id="O2" value="0" lower_limit="-0.2" upper_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" lower_limit="-0.4" upper_limit="-0.1"/>
                    <measurement group_id="O2" value="0" lower_limit="-0.2" upper_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline ABLe Control Score</title>
        <description>The ABLE Control Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the ability to control bowel movements. Minimum score is 0 = no problems with urgency to empty bowels wthout warning; maximum score is 4 = frequent and bothersome urgency to empty bowels wthout warning.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline ABLe Control Score</title>
          <description>The ABLE Control Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the ability to control bowel movements. Minimum score is 0 = no problems with urgency to empty bowels wthout warning; maximum score is 4 = frequent and bothersome urgency to empty bowels wthout warning.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" lower_limit="-0.5" upper_limit="-0.2"/>
                    <measurement group_id="O2" value="-0.3" lower_limit="-0.6" upper_limit="-0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" lower_limit="-0.8" upper_limit="-0.4"/>
                    <measurement group_id="O2" value="-0.6" lower_limit="-0.9" upper_limit="-0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline ABLe Ancillary Bowel Symptoms Score</title>
        <description>The ABLE Ancillary Bowel Symptoms Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the frequency and impact of ancially bowel symptoms. Minimum score is 0 = no problems with pain or incomplete emptying; maximum score is 4 = frequent and bothersome pain or incomplete emptying.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline ABLe Ancillary Bowel Symptoms Score</title>
          <description>The ABLE Ancillary Bowel Symptoms Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the frequency and impact of ancially bowel symptoms. Minimum score is 0 = no problems with pain or incomplete emptying; maximum score is 4 = frequent and bothersome pain or incomplete emptying.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" lower_limit="-0.5" upper_limit="-0.2"/>
                    <measurement group_id="O2" value="-0.3" lower_limit="-0.6" upper_limit="-0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" lower_limit="-0.9" upper_limit="-0.5"/>
                    <measurement group_id="O2" value="-0.4" lower_limit="-0.6" upper_limit="-0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline ABLe Overall Score</title>
        <description>The ABLE Overall Score is the summary score of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the frequency and impact of accidental bowel leakage and related symptoms. Minimum score is 0 = no problems with bowel leakage and related symptoms; maximum score is 4 = frequent and bothersome problems with bowel leakage and related symptoms.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline ABLe Overall Score</title>
          <description>The ABLE Overall Score is the summary score of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the frequency and impact of accidental bowel leakage and related symptoms. Minimum score is 0 = no problems with bowel leakage and related symptoms; maximum score is 4 = frequent and bothersome problems with bowel leakage and related symptoms.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" lower_limit="-0.5" upper_limit="-0.2"/>
                    <measurement group_id="O2" value="-0.3" lower_limit="-0.6" upper_limit="-0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" lower_limit="-0.9" upper_limit="-0.5"/>
                    <measurement group_id="O2" value="-0.4" lower_limit="-0.6" upper_limit="-0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Patient Global Symptom Control</title>
        <description>The Patient Global Symptom Control (PGSC) is a patient-reported measure of perceived agreement that symptoms are under control, as assessed on a scale of 1 (Disagree Strongly) to 5 (Agree Strongly). Included here are participants who had reported disagreements as indicated by a rating of 1 (Disagree Strongly) or 2 (Disagree)</description>
        <time_frame>Baseline and 4, 8, and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Symptom Control</title>
          <description>The Patient Global Symptom Control (PGSC) is a patient-reported measure of perceived agreement that symptoms are under control, as assessed on a scale of 1 (Disagree Strongly) to 5 (Agree Strongly). Included here are participants who had reported disagreements as indicated by a rating of 1 (Disagree Strongly) or 2 (Disagree)</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="111"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No Control</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Control</title>
                  <measurement_list>
                    <measurement group_id="O1" value="93"/>
                    <measurement group_id="O2" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No Control</title>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Control</title>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No Control</title>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Control</title>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="104"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No Control</title>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Control</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline FIQL Lifestyle Score</title>
        <description>The FIQL Lifestyle Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline FIQL Lifestyle Score</title>
          <description>The FIQL Lifestyle Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" lower_limit="0.2" upper_limit="0.5"/>
                    <measurement group_id="O2" value="0.4" lower_limit="0.2" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" lower_limit="0.5" upper_limit="0.8"/>
                    <measurement group_id="O2" value="0.4" lower_limit="0.2" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline FIQL Coping Score</title>
        <description>The FIQL Coping Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline FIQL Coping Score</title>
          <description>The FIQL Coping Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="0.3" upper_limit="0.5"/>
                    <measurement group_id="O2" value="0.4" lower_limit="0.2" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" lower_limit="0.5" upper_limit="0.8"/>
                    <measurement group_id="O2" value="0.5" lower_limit="0.3" upper_limit="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline FIQL Depression Score</title>
        <description>The FIQL Depression Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline FIQL Depression Score</title>
          <description>The FIQL Depression Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" lower_limit="0.2" upper_limit="0.4"/>
                    <measurement group_id="O2" value="0.2" lower_limit="0" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0.4" upper_limit="0.6"/>
                    <measurement group_id="O2" value="0.2" lower_limit="0.1" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline FIQL Embarrassment Score</title>
        <description>The FIQL Embarrassment Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline FIQL Embarrassment Score</title>
          <description>The FIQL Embarrassment Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="0.3" upper_limit="0.5"/>
                    <measurement group_id="O2" value="0.4" lower_limit="0.2" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" lower_limit="0.6" upper_limit="0.9"/>
                    <measurement group_id="O2" value="0.4" lower_limit="0.3" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline FISI Patient Score</title>
        <description>The FISI Patient Score is a summary score of the validated Fecal Incontinence Severity Index questionnaire which provides a summary metric of the severity of fecal incontinence from the patient's perspective. Minimum score is 0 = no fecal incontinence; maximum score is 61 = very severe fecal incontinence. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline FISI Patient Score</title>
          <description>The FISI Patient Score is a summary score of the validated Fecal Incontinence Severity Index questionnaire which provides a summary metric of the severity of fecal incontinence from the patient's perspective. Minimum score is 0 = no fecal incontinence; maximum score is 61 = very severe fecal incontinence. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.9" lower_limit="-7.1" upper_limit="-2.8"/>
                    <measurement group_id="O2" value="-5.9" lower_limit="-8.7" upper_limit="-3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.5" lower_limit="-9.7" upper_limit="-5.3"/>
                    <measurement group_id="O2" value="-6.7" lower_limit="-10.1" upper_limit="-3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline FISI Doctor Score</title>
        <description>The FISI Doctor Score is a summary score of the validated Fecal Incontinence Severity Index questionnaire which provides a summary metric of the severity of fecal incontinence from the doctor's perspective. Minimum score is 0 = no fecal incontinence; maximum score is 57 = very severe fecal incontinence. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline FISI Doctor Score</title>
          <description>The FISI Doctor Score is a summary score of the validated Fecal Incontinence Severity Index questionnaire which provides a summary metric of the severity of fecal incontinence from the doctor's perspective. Minimum score is 0 = no fecal incontinence; maximum score is 57 = very severe fecal incontinence. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5" lower_limit="-7.3" upper_limit="-2.8"/>
                    <measurement group_id="O2" value="-6.3" lower_limit="-9.2" upper_limit="-3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.4" lower_limit="-9.8" upper_limit="-5"/>
                    <measurement group_id="O2" value="-7" lower_limit="-10.5" upper_limit="-3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline MMHQ Incontinence Impact Score</title>
        <description>The MMHQ Incontinence Impact Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline MMHQ Incontinence Impact Score</title>
          <description>The MMHQ Incontinence Impact Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="104"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.4" lower_limit="-14.5" upper_limit="-4.2"/>
                    <measurement group_id="O2" value="-11.3" lower_limit="-17.9" upper_limit="-4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.2" lower_limit="-23" upper_limit="-11.5"/>
                    <measurement group_id="O2" value="-15.9" lower_limit="-23.4" upper_limit="-8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline MMHQ Role Limitations Score</title>
        <description>The MMHQ Role Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline MMHQ Role Limitations Score</title>
          <description>The MMHQ Role Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.8" lower_limit="-14.6" upper_limit="-5.1"/>
                    <measurement group_id="O2" value="-3.1" lower_limit="-10.4" upper_limit="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.5" lower_limit="-22.6" upper_limit="-12.3"/>
                    <measurement group_id="O2" value="-9.9" lower_limit="-17.1" upper_limit="-2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline MMHQ Physical Limitations Score</title>
        <description>The MMHQ Physical Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline MMHQ Physical Limitations Score</title>
          <description>The MMHQ Physical Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.3" lower_limit="-15.3" upper_limit="-5.3"/>
                    <measurement group_id="O2" value="-3.8" lower_limit="-9.2" upper_limit="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.4" lower_limit="-25.5" upper_limit="-15.2"/>
                    <measurement group_id="O2" value="-10.6" lower_limit="-16.6" upper_limit="-4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline MMHQ Social Limitations Score</title>
        <description>The MMHQ Social Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline MMHQ Social Limitations Score</title>
          <description>The MMHQ Social Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.6" lower_limit="-15.3" upper_limit="-3.9"/>
                    <measurement group_id="O2" value="-1.8" lower_limit="-7.5" upper_limit="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.8" lower_limit="-20.1" upper_limit="-9.5"/>
                    <measurement group_id="O2" value="-8.6" lower_limit="-14.6" upper_limit="-2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline MMHQ Personal Relationship Score</title>
        <description>The MMHQ Personal Relationship Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline MMHQ Personal Relationship Score</title>
          <description>The MMHQ Personal Relationship Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="70"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5" lower_limit="-11.6" upper_limit="1.6"/>
                    <measurement group_id="O2" value="-2.2" lower_limit="-11.5" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.2" lower_limit="-11.3" upper_limit="-1"/>
                    <measurement group_id="O2" value="-11.4" lower_limit="-23.2" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline MMHQ Emotional Function Score</title>
        <description>The MMHQ Emotional Function Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline MMHQ Emotional Function Score</title>
          <description>The MMHQ Emotional Function Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.2" lower_limit="-11.7" upper_limit="-2.7"/>
                    <measurement group_id="O2" value="-4.6" lower_limit="-10.6" upper_limit="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.4" lower_limit="-19.1" upper_limit="-9.6"/>
                    <measurement group_id="O2" value="-7.4" lower_limit="-14.3" upper_limit="-0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline MMHQ Sleep/Energy Score</title>
        <description>The MMHQ Sleep/Energy Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline MMHQ Sleep/Energy Score</title>
          <description>The MMHQ Sleep/Energy Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.2" lower_limit="-11.4" upper_limit="-3"/>
                    <measurement group_id="O2" value="-4.3" lower_limit="-10.8" upper_limit="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11" lower_limit="-15.2" upper_limit="-6.8"/>
                    <measurement group_id="O2" value="-6.4" lower_limit="-12.4" upper_limit="-0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline MMHQ Severity Measures Score</title>
        <description>The MMHQ Severity Measures Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline MMHQ Severity Measures Score</title>
          <description>The MMHQ Severity Measures Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="104"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.1" lower_limit="-13.2" upper_limit="-5"/>
                    <measurement group_id="O2" value="-10.7" lower_limit="-15.9" upper_limit="-5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17" lower_limit="-21.3" upper_limit="-12.6"/>
                    <measurement group_id="O2" value="-11.8" lower_limit="-17" upper_limit="-6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline CRAIQ Score</title>
        <description>The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline CRAIQ Score</title>
          <description>The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.9" lower_limit="-17.1" upper_limit="-8.7"/>
                    <measurement group_id="O2" value="-12.8" lower_limit="-19.6" upper_limit="-5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.1" lower_limit="-24.2" upper_limit="-14"/>
                    <measurement group_id="O2" value="-14.5" lower_limit="-22.2" upper_limit="-6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline POPIQ Score</title>
        <description>The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline POPIQ Score</title>
          <description>The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.3" lower_limit="-7.2" upper_limit="0.7"/>
                    <measurement group_id="O2" value="-5.1" lower_limit="-8.8" upper_limit="-1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.2" lower_limit="-8.1" upper_limit="-2.3"/>
                    <measurement group_id="O2" value="-5.6" lower_limit="-9.8" upper_limit="-1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline UIQ Score</title>
        <description>The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline UIQ Score</title>
          <description>The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.3" lower_limit="-6.4" upper_limit="-0.1"/>
                    <measurement group_id="O2" value="-10.2" lower_limit="-15.3" upper_limit="-5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.2" lower_limit="-10.6" upper_limit="-3.8"/>
                    <measurement group_id="O2" value="-10.5" lower_limit="-16.5" upper_limit="-4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline PFIQ Score</title>
        <description>The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.</description>
        <time_frame>8 and 12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline PFIQ Score</title>
          <description>The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.4" lower_limit="-27.7" upper_limit="-11.1"/>
                    <measurement group_id="O2" value="-28.1" lower_limit="-39.9" upper_limit="-16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-31.5" lower_limit="-40.3" upper_limit="-22.7"/>
                    <measurement group_id="O2" value="-30.7" lower_limit="-43.7" upper_limit="-17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline PAC-SYM Abdominal Score</title>
        <description>The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.</description>
        <time_frame>12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline PAC-SYM Abdominal Score</title>
          <description>The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" lower_limit="-0.6" upper_limit="-0.3"/>
                    <measurement group_id="O2" value="-0.2" lower_limit="-0.4" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline PAC-SYM Rectal Score</title>
        <description>The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.</description>
        <time_frame>12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline PAC-SYM Rectal Score</title>
          <description>The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" lower_limit="-0.3" upper_limit="0.0"/>
                    <measurement group_id="O2" value="-0.1" lower_limit="-0.3" upper_limit="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline PAC-SYM Stool Score</title>
        <description>The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.</description>
        <time_frame>12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline PAC-SYM Stool Score</title>
          <description>The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" lower_limit="-0.5" upper_limit="-0.1"/>
                    <measurement group_id="O2" value="-0.2" lower_limit="-0.5" upper_limit="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline PAC-SYM Total Score</title>
        <description>The Patient Assessment of Constipation - Symptom (PAC-SYM) is a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-missing responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very severe). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.</description>
        <time_frame>12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline PAC-SYM Total Score</title>
          <description>The Patient Assessment of Constipation - Symptom (PAC-SYM) is a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-missing responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very severe). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" lower_limit="-0.4" upper_limit="-0.2"/>
                    <measurement group_id="O2" value="-0.2" lower_limit="-0.4" upper_limit="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline PISQ-IR NSA-PR Score</title>
        <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Partner Related (NSA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
        <time_frame>12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were not sexually active.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline PISQ-IR NSA-PR Score</title>
          <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Partner Related (NSA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were not sexually active.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="-0.3" upper_limit="0.4"/>
                    <measurement group_id="O2" value="-0.1" lower_limit="-0.4" upper_limit="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline PISQ-IR NSA-CS Score</title>
        <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Specific (NSA-CS) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
        <time_frame>12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were not sexually active.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline PISQ-IR NSA-CS Score</title>
          <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Specific (NSA-CS) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were not sexually active.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="-0.1" upper_limit="0.5"/>
                    <measurement group_id="O2" value="0.2" lower_limit="-0.2" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline PISQ-IR NSA-GQA Score</title>
        <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Global Quality Rating (NSA-GQA) ranges from 1 to 4.5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
        <time_frame>12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were not sexually active.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline PISQ-IR NSA-GQA Score</title>
          <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Global Quality Rating (NSA-GQA) ranges from 1 to 4.5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were not sexually active.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="0.1" upper_limit="0.6"/>
                    <measurement group_id="O2" value="0.3" lower_limit="0" upper_limit="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline PISQ-IR NSA-CI Score</title>
        <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Impact (NSA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
        <time_frame>12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected for participants that were not sexually active.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline PISQ-IR NSA-CI Score</title>
          <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Impact (NSA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected for participants that were not sexually active.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="0.1" upper_limit="0.7"/>
                    <measurement group_id="O2" value="0.3" lower_limit="0.0" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline PISQ-IR SA-AO Score</title>
        <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Arousal Orgasm (SA-AO) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
        <time_frame>12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure is only calculated for participants that were sexually active.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline PISQ-IR SA-AO Score</title>
          <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Arousal Orgasm (SA-AO) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure is only calculated for participants that were sexually active.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="0.1" upper_limit="0.4"/>
                    <measurement group_id="O2" value="0.2" lower_limit="0.0" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline PISQ-IR SA-PR Score</title>
        <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Partner Related (SA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
        <time_frame>12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure is only collected from participants that were sexually active.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline PISQ-IR SA-PR Score</title>
          <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Partner Related (SA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure is only collected from participants that were sexually active.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="0.0" upper_limit="0.3"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-0.2" upper_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline PISQ-IR SA-CS Score</title>
        <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Specific (SA-CS) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
        <time_frame>12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were sexually active.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline PISQ-IR SA-CS Score</title>
          <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Specific (SA-CS) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were sexually active.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" lower_limit="0.1" upper_limit="0.6"/>
                    <measurement group_id="O2" value="0.5" lower_limit="0.2" upper_limit="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline PISQ-IR SA-GQR Score</title>
        <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Global Quality Rating (SA-GQR) ranges from 1 to 4.75 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
        <time_frame>12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were sexually active.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline PISQ-IR SA-GQR Score</title>
          <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Global Quality Rating (SA-GQR) ranges from 1 to 4.75 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were sexually active.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" lower_limit="0.1" upper_limit="0.6"/>
                    <measurement group_id="O2" value="0.4" lower_limit="-0.1" upper_limit="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline PISQ-IR SA-CI Score</title>
        <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Impact (SA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
        <time_frame>12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were sexually active.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline PISQ-IR SA-CI Score</title>
          <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Impact (SA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were sexually active.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="0.2" upper_limit="0.6"/>
                    <measurement group_id="O2" value="0.3" lower_limit="0.0" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline PISQ-IR SA-D Score</title>
        <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Desire (SA-D) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
        <time_frame>12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were sexually active.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline PISQ-IR SA-D Score</title>
          <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Desire (SA-D) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were sexually active.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-0.1" upper_limit="0.2"/>
                    <measurement group_id="O2" value="0.2" lower_limit="-0.2" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline PISQ-IR SA-AVG Score</title>
        <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Average (SA-AVG) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
        <time_frame>12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were sexually active.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline PISQ-IR SA-AVG Score</title>
          <description>The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Average (SA-AVG) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were sexually active.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="0.1" upper_limit="0.4"/>
                    <measurement group_id="O2" value="0.3" lower_limit="0.1" upper_limit="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline FIAI Hygiene Index Score</title>
        <description>The Fecal Incontinence Adaptation Index (FIAI) is a validated form which measures the adaptation behavios resulting from fecal incontinence. It consists of two subscales: Hygiene (range: 0-100) and Avoidance (range: 0-100). Scores are cal calculated as the average of the non-missing responses multiplied by 25. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
        <time_frame>12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline FIAI Hygiene Index Score</title>
          <description>The Fecal Incontinence Adaptation Index (FIAI) is a validated form which measures the adaptation behavios resulting from fecal incontinence. It consists of two subscales: Hygiene (range: 0-100) and Avoidance (range: 0-100). Scores are cal calculated as the average of the non-missing responses multiplied by 25. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.2" lower_limit="-14" upper_limit="-6.5"/>
                    <measurement group_id="O2" value="-2.8" lower_limit="-8.4" upper_limit="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline FIAI Avoidance Index Score</title>
        <description>The Fecal Incontinence Adaptation Index (FIAI) is a validated form which measures the adaptation behavios resulting from fecal incontinence. It consists of two subscales: Hygiene (range: 0-100) and Avoidance (range: 0-100). Scores are cal calculated as the average of the non-missing responses multiplied by 25. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
        <time_frame>12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline FIAI Avoidance Index Score</title>
          <description>The Fecal Incontinence Adaptation Index (FIAI) is a validated form which measures the adaptation behavios resulting from fecal incontinence. It consists of two subscales: Hygiene (range: 0-100) and Avoidance (range: 0-100). Scores are cal calculated as the average of the non-missing responses multiplied by 25. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.8" lower_limit="-16.1" upper_limit="-9.4"/>
                    <measurement group_id="O2" value="-6.4" lower_limit="-12.2" upper_limit="-0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline SF-12 Aggregate Physical Score</title>
        <description>The 12-Item Short-Form Health Survey (SF-12) is a validated survey which assesses overall physical and mental health. The Aggregate Physical Score ranges from 24 to 56.6 with higher scores indicating greater physical health. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
        <time_frame>12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline SF-12 Aggregate Physical Score</title>
          <description>The 12-Item Short-Form Health Survey (SF-12) is a validated survey which assesses overall physical and mental health. The Aggregate Physical Score ranges from 24 to 56.6 with higher scores indicating greater physical health. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" lower_limit="1.1" upper_limit="4.2"/>
                    <measurement group_id="O2" value="2.1" lower_limit="-1" upper_limit="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline SF-12 Aggregate Mental Score</title>
        <description>The 12-Item Short-Form Health Survey (SF-12) is a validated survey which assesses overall physical and mental health. The Aggregate Mental Score ranges from 19.06 to 60.86 with higher scores indicating greater mental health. The outcome is calculated as the difference in score at 12 weeks and the score at baseline</description>
        <time_frame>12 Weeks</time_frame>
        <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PTNS</title>
            <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline SF-12 Aggregate Mental Score</title>
          <description>The 12-Item Short-Form Health Survey (SF-12) is a validated survey which assesses overall physical and mental health. The Aggregate Mental Score ranges from 19.06 to 60.86 with higher scores indicating greater mental health. The outcome is calculated as the difference in score at 12 weeks and the score at baseline</description>
          <population>An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" lower_limit="-1.3" upper_limit="3.1"/>
                    <measurement group_id="O2" value="-0.7" lower_limit="-4.2" upper_limit="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 Weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>PTNS</title>
          <description>PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
        </group>
        <group group_id="E2">
          <title>Sham</title>
          <description>Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.&#xD;
ES-130: The ES-130 device will be used for the indication of &quot;Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence&quot; using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 17.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0.00</frequency_threshold>
        <default_vocab>MedDRA 17.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="72" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Chalazion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Photopsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Anal paraesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Chapped lips</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="111"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Adverse drug reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Application site pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Application site paraesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Medical device site haemorrhage</sub_title>
                <counts group_id="E1" events="14" subjects_affected="9" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Medical device site pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Puncture site pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic steatosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Multiple allergies</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Eye infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Gastrointestinal viral infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="111"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Streptococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="111"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Procedural haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood potassium decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Colonoscopy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Endoscopy gastrointestinal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Oesophagogastroduodenoscopy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Gluten sensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="111"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Diastasis recti abdominis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Limb discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Muscle tightness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Muscle twitching</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Amnesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Cervical radiculopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Nerve compression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="16" subjects_affected="11" subjects_at_risk="111"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Urge incontinence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Fibrocystic breast disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Uterine haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Vaginal discharge</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Vulvovaginal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Dry throat</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Sinus disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Upper-airway cough syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Ingrowing nail</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Rash generalised</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Skin discolouration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Skin reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Abdominal hernia repair</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Abdominoplasty</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Medical device removal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Marie Gantz</name_or_title>
      <organization>RTI International</organization>
      <phone>919-597-5110</phone>
      <email>mgantz@rti.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03278613
org study id: 12865-29
secondary id: 2U24HD069031-06
secondary id: 2UG1HD069013-06
secondary id: 5UG1HD041267-18
secondary id: 5UG1HD069010-07
secondary id: 5UG1HD069006-07
secondary id: 5UG1HD041261-17
secondary id: 5UG1HD054214-12
secondary id: 5UG1HD054241-12
nct id: NCT03278613
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
This study is a multi-center, randomized clinical trial of women with refractory accidental
      bowel leakage (ABL) symptoms who have failed to achieve satisfactory symptom control from 2
      first-line treatments for ABL: supervised pelvic muscle training (PMT) and constipating
      medication. The purpose of this study is to compare percutaneous tibial nerve stimulation
      (PTNS) to a validated sham to determine if PTNS is effective for the treatment of fecal
      incontinence (FI) in women.

      The investigators will test the null hypothesis that change from baseline in St. Mark's
      (Vaizey) score after 12 weeks of stimulation is not significantly different in women with
      symptomatic ABL receiving PTNS treatments compared to women receiving sham PTNS treatments.
The overarching goal of this randomized clinical trial is to determine if PTNS is more
      effective than sham PTNS for the treatment of FI in women after 12 weeks of treatment and 1
      year after initiating treatment. This is a two-part trial with a Run-In Phase prior to
      randomization. The trial has the following primary aim:

      To determine whether the change from baseline in St. Mark's (Vaizey) score in women with
      symptomatic ABL undergoing PTNS differs from sham after 12 weeks of stimulation.

      Additional secondary aims include:

        1. To compare changes from baseline in self-reported functional outcomes after 12 weekly
           stimulation sessions in both PTNS and sham groups in Part 1.

        2. To determine whether symptom relief amongst study "responders" can be sustained for one
           year with maintenance treatments in Part II.

        3. To determine the impact of completing a bowel diary and receiving education on FI on
           symptom severity.

        4. To determine the ability of the PFDN ABL phone app bowel diary to detect changes from
           baseline in fecal incontinence episodes recorded to after 12 weeks of stimulation
           sessions.

        5. To determine the association between St. Mark's score and both fat and fiber intake
           alone and in combination.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: Participants will remain masked to subject treatment assignment throughout the trial. To maintain masking of participants, the duration of treatment sessions for both the PTNS and sham groups will be 30 minutes and will be conducted with subjects in a supine position with the knees comfortably abducted and flexed. The leg and foot involved in treatment will be obscured from the subject's view with a portable anesthesia drape frame to which an exam sheet will be secured.
measure: Change From Baseline St. Mark's (Vaizey) Score
time frame: 4, 8, and 12 Weeks
description: The primary outcome measure is the change from baseline in St. Mark's (Vaizey) Score 12 weeks after treatment initiation to compare the outcomes of post-tibial nerve stimulation (PTNS) versus sham stimulation. The St. Mark's (Vaizey) score, published in 1999, is commonly used in clinical studies and reports and was based on the Jorge-Wexner score but added two further items for assessment: the use of constipating medication and the presence of fecal urgency. Minimum score is 0 = perfect continence; maximum score is 24 = totally incontinent. Change from baseline is calculated as Week [4, 8, or 12] Score minus the score at baseline.
measure: Responder to Treatment
time frame: 4, 8, and 12 Weeks
description: Responder status is based on the primary chnage from St. Mark's Score. A responder is defined as any particpant with at least a 4 point reduction in score compared to their baseline score
measure: Change From Baseline Number of Fecal Incontinence Events Per Week
time frame: 8 and 12 Weeks
description: Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of fecal incontinence episodes per week at 8 and 12 weeks and the number of fecal incontinence episodes at baseline.
measure: Change From Baseline Number of Urge Fecal Incontinence Events Per Week
time frame: 8 and 12 Weeks
description: Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of urge fecal incontinence episodes per week at 8 and 12 weeks and the number of urge fecal incontinence episodes at baseline.
measure: Change From Baseline Number of Bowel Movements Per Week
time frame: 8 and 12 Weeks
description: Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of bowel movements per week at 8 and 12 weeks and the number of bowel movements at baseline.
measure: Change From Baseline Number of Urge Bowel Movements Per Week
time frame: 8 and 12 Weeks
description: Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of urge bowel movements per week at 8 and 12 weeks and the number of urge bowel movements at baseline.
measure: Change From Baseline Number of Days Without Fecal Incontinence Episodes Per Week
time frame: 8 and 12 Weeks
description: Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of days without fecal incontinence episodes per week at 8 and 12 weeks and the number of days without fecal incontinence episodes at baseline.
measure: 50% Improvement in Fecal Incontinence Episodes Per Week
time frame: 8 and 12 Weeks
description: Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome is calculated as any participant with a 50% reduction in fecal incontinence episodes per week at 8 and 12 weeks compared to the fecal incontinence episodes at baseline
measure: 75% Improvement in Fecal Incontinence Episodes Per Week
time frame: 8 and 12 Weeks
description: Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome is calculated as any participant with a 75% reduction in fecal incontinence episodes per week at 8, and 12 weeks compared to the fecal incontinence episodes at baseline.
measure: Patient Global Impression-Improvement
time frame: 4, 8, and 12 Weeks
description: The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better) or 2 (much better)
measure: Change From Baseline ABLe Liquid Score
time frame: 8 and 12 Weeks
description: The ABLE Liquid Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of liquid stool. Minimum score is 0 = no problem with liquid stool leakage; maximum score is 4 = frequent, bothersome leakage of large amounts of liquid stool. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
measure: Change From Baseline ABLe Solid Score
time frame: 8 and 12 Weeks
description: The ABLE Solid Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of solid stool. Minimum score is 0 = no problem with solid stool leakage; maximum score is 4 = frequent, bothersome leakage of large amounts of solid stool. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
measure: Change From Baseline ABLe Mucus Score
time frame: 8 and 12 Weeks
description: The ABLE Mucus Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of mucus from the rectum. Minimum score is 0 = no problem with mucus leakage from the rectum; maximum score is 4 = frequent, bothersome leakage of large amounts of mucus from the rectum. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
measure: Change From Baseline ABLe Gas Score
time frame: 8 and 12 Weeks
description: The ABLE Gas Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of gas from the rectum. Minimum score is 0 = no problem with gas leakage from the rectum; maximum score is 4 = frequent and bothersome leakage of gas from the rectum. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
measure: Change From Baseline ABLe Predictability/Awareness Score
time frame: 8 and 12 Weeks
description: The ABLE Predictability/Awareness Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the predictability of bowel leakage events. Minimum score is 0 = no problems with leakage; maximum score is 4 = leakage without awareness or predictability. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
measure: Change From Baseline ABLe Control Score
time frame: 8 and 12 Weeks
description: The ABLE Control Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the ability to control bowel movements. Minimum score is 0 = no problems with urgency to empty bowels wthout warning; maximum score is 4 = frequent and bothersome urgency to empty bowels wthout warning.
measure: Change From Baseline ABLe Ancillary Bowel Symptoms Score
time frame: 8 and 12 Weeks
description: The ABLE Ancillary Bowel Symptoms Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the frequency and impact of ancially bowel symptoms. Minimum score is 0 = no problems with pain or incomplete emptying; maximum score is 4 = frequent and bothersome pain or incomplete emptying.
measure: Change From Baseline ABLe Overall Score
time frame: 8 and 12 Weeks
description: The ABLE Overall Score is the summary score of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the frequency and impact of accidental bowel leakage and related symptoms. Minimum score is 0 = no problems with bowel leakage and related symptoms; maximum score is 4 = frequent and bothersome problems with bowel leakage and related symptoms.
measure: Patient Global Symptom Control
time frame: Baseline and 4, 8, and 12 Weeks
description: The Patient Global Symptom Control (PGSC) is a patient-reported measure of perceived agreement that symptoms are under control, as assessed on a scale of 1 (Disagree Strongly) to 5 (Agree Strongly). Included here are participants who had reported disagreements as indicated by a rating of 1 (Disagree Strongly) or 2 (Disagree)
measure: Change From Baseline FIQL Lifestyle Score
time frame: 8 and 12 Weeks
description: The FIQL Lifestyle Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
measure: Change From Baseline FIQL Coping Score
time frame: 8 and 12 Weeks
description: The FIQL Coping Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
measure: Change From Baseline FIQL Depression Score
time frame: 8 and 12 Weeks
description: The FIQL Depression Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
measure: Change From Baseline FIQL Embarrassment Score
time frame: 8 and 12 Weeks
description: The FIQL Embarrassment Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
measure: Change From Baseline FISI Patient Score
time frame: 8 and 12 Weeks
description: The FISI Patient Score is a summary score of the validated Fecal Incontinence Severity Index questionnaire which provides a summary metric of the severity of fecal incontinence from the patient's perspective. Minimum score is 0 = no fecal incontinence; maximum score is 61 = very severe fecal incontinence. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
measure: Change From Baseline FISI Doctor Score
time frame: 8 and 12 Weeks
description: The FISI Doctor Score is a summary score of the validated Fecal Incontinence Severity Index questionnaire which provides a summary metric of the severity of fecal incontinence from the doctor's perspective. Minimum score is 0 = no fecal incontinence; maximum score is 57 = very severe fecal incontinence. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
measure: Change From Baseline MMHQ Incontinence Impact Score
time frame: 8 and 12 Weeks
description: The MMHQ Incontinence Impact Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
measure: Change From Baseline MMHQ Role Limitations Score
time frame: 8 and 12 Weeks
description: The MMHQ Role Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
measure: Change From Baseline MMHQ Physical Limitations Score
time frame: 8 and 12 Weeks
description: The MMHQ Physical Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
measure: Change From Baseline MMHQ Social Limitations Score
time frame: 8 and 12 Weeks
description: The MMHQ Social Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
measure: Change From Baseline MMHQ Personal Relationship Score
time frame: 8 and 12 Weeks
description: The MMHQ Personal Relationship Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
measure: Change From Baseline MMHQ Emotional Function Score
time frame: 8 and 12 Weeks
description: The MMHQ Emotional Function Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
measure: Change From Baseline MMHQ Sleep/Energy Score
time frame: 8 and 12 Weeks
description: The MMHQ Sleep/Energy Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
measure: Change From Baseline MMHQ Severity Measures Score
time frame: 8 and 12 Weeks
description: The MMHQ Severity Measures Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
measure: Change From Baseline CRAIQ Score
time frame: 8 and 12 Weeks
description: The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
measure: Change From Baseline POPIQ Score
time frame: 8 and 12 Weeks
description: The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
measure: Change From Baseline UIQ Score
time frame: 8 and 12 Weeks
description: The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
measure: Change From Baseline PFIQ Score
time frame: 8 and 12 Weeks
description: The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
measure: Change From Baseline PAC-SYM Abdominal Score
time frame: 12 Weeks
description: The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.
measure: Change From Baseline PAC-SYM Rectal Score
time frame: 12 Weeks
description: The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.
measure: Change From Baseline PAC-SYM Stool Score
time frame: 12 Weeks
description: The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.
measure: Change From Baseline PAC-SYM Total Score
time frame: 12 Weeks
description: The Patient Assessment of Constipation - Symptom (PAC-SYM) is a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-missing responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very severe). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.
measure: Change From Baseline PISQ-IR NSA-PR Score
time frame: 12 Weeks
description: The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Partner Related (NSA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
measure: Change From Baseline PISQ-IR NSA-CS Score
time frame: 12 Weeks
description: The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Specific (NSA-CS) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
measure: Change From Baseline PISQ-IR NSA-GQA Score
time frame: 12 Weeks
description: The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Global Quality Rating (NSA-GQA) ranges from 1 to 4.5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
measure: Change From Baseline PISQ-IR NSA-CI Score
time frame: 12 Weeks
description: The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Impact (NSA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
measure: Change From Baseline PISQ-IR SA-AO Score
time frame: 12 Weeks
description: The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Arousal Orgasm (SA-AO) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
measure: Change From Baseline PISQ-IR SA-PR Score
time frame: 12 Weeks
description: The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Partner Related (SA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
measure: Change From Baseline PISQ-IR SA-CS Score
time frame: 12 Weeks
description: The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Specific (SA-CS) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
measure: Change From Baseline PISQ-IR SA-GQR Score
time frame: 12 Weeks
description: The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Global Quality Rating (SA-GQR) ranges from 1 to 4.75 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
measure: Change From Baseline PISQ-IR SA-CI Score
time frame: 12 Weeks
description: The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Impact (SA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
measure: Change From Baseline PISQ-IR SA-D Score
time frame: 12 Weeks
description: The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Desire (SA-D) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
measure: Change From Baseline PISQ-IR SA-AVG Score
time frame: 12 Weeks
description: The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Average (SA-AVG) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
measure: Change From Baseline FIAI Hygiene Index Score
time frame: 12 Weeks
description: The Fecal Incontinence Adaptation Index (FIAI) is a validated form which measures the adaptation behavios resulting from fecal incontinence. It consists of two subscales: Hygiene (range: 0-100) and Avoidance (range: 0-100). Scores are cal calculated as the average of the non-missing responses multiplied by 25. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
measure: Change From Baseline FIAI Avoidance Index Score
time frame: 12 Weeks
description: The Fecal Incontinence Adaptation Index (FIAI) is a validated form which measures the adaptation behavios resulting from fecal incontinence. It consists of two subscales: Hygiene (range: 0-100) and Avoidance (range: 0-100). Scores are cal calculated as the average of the non-missing responses multiplied by 25. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
measure: Change From Baseline SF-12 Aggregate Physical Score
time frame: 12 Weeks
description: The 12-Item Short-Form Health Survey (SF-12) is a validated survey which assesses overall physical and mental health. The Aggregate Physical Score ranges from 24 to 56.6 with higher scores indicating greater physical health. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
measure: Change From Baseline SF-12 Aggregate Mental Score
time frame: 12 Weeks
description: The 12-Item Short-Form Health Survey (SF-12) is a validated survey which assesses overall physical and mental health. The Aggregate Mental Score ranges from 19.06 to 60.86 with higher scores indicating greater mental health. The outcome is calculated as the difference in score at 12 weeks and the score at baseline
arm group label: Percutaneous Tibial Nerve Stimulation (PTNS)
arm group type: Experimental
description: PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.
arm group label: Validated Sham
arm group type: Sham Comparator
description: Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.
intervention type: Device
intervention name: ES-130
description: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
arm group label: Percutaneous Tibial Nerve Stimulation (PTNS)
arm group label: Validated Sham
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Halina M Zyczynski, MD
role: Study Chair
affiliation: Magee-Women's Hospital, Department of Obstetrics and Gynecology
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country: United States
responsible party type: Sponsor
mesh term: Fecal Incontinence
sharing ipd: No
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