<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/NCT03252951</url>
  </required_header>
  <id_info>
    <org_study_id>141728</org_study_id>
    <nct_id>NCT03252951</nct_id>
  </id_info>
  <brief_title>Physical Therapy for Anal Incontinence</brief_title>
  <official_title>An Innovative Rehabilitation Approach for Women With Anal Incontinence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>San Diego State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>San Diego State University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anal incontinence is a significant public health problem estimated to affect 7-15% of women&#xD;
      in the United States. Traditional rehabilitation strategies include biofeedback and Kegel&#xD;
      exercises for pelvic floor muscle strengthening, but this strategy does not incorporate&#xD;
      strategies for resistance training that are known to cause muscle strengthening and&#xD;
      hypertrophy in other muscles in the body. This study aims to investigate whether a novel&#xD;
      pelvic floor resistance exercise program will increase pelvic floor muscle strength and&#xD;
      improve anal incontinence and has the potential to impact rehabilitation strategies for the&#xD;
      millions of women affected anal incontinence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current proposal is focused on examining whether a novel resistance exercise program for&#xD;
      the pelvic floor will strengthen pelvic floor muscles and improve symptoms in women with anal&#xD;
      incontinence. Anal incontinence is a significant public health issue that is estimated to&#xD;
      impact 7-15% of women. Traditional rehabilitation strategies such as Kegel exercises and&#xD;
      biofeedback are a noninvasive strategy designed to strengthen the pelvic floor muscles,&#xD;
      however, these exercises are performed with no resistance. There is a large body of evidence&#xD;
      indicating that for muscle strengthening and hypertrophy to occur, exercises must be&#xD;
      performed against resistance. Therefore, we have designed a novel exercise program for the&#xD;
      pelvic floor that incorporates principals of resistance training known to be effective in&#xD;
      other muscles in the body. The long-term goal of this research is to determine the most&#xD;
      appropriate noninvasive strategies and interventions to improve pelvic floor function and&#xD;
      symptoms of anal incontinence. This project is the first step in achieving this goal. The&#xD;
      overall purpose of the current proposal is to determine whether novel physical therapy&#xD;
      interventions are more effective than traditional biofeedback strategies in the treatment of&#xD;
      anal incontinence. The specific aims of the proposal are: (1) To describe the use of the&#xD;
      Functional Lumen Imaging Probe (FLIP) for pelvic floor exercise; (2) To determine whether&#xD;
      eccentric, concentric, or isometric exercise training of the pelvic floor has a positive&#xD;
      impact on the pelvic floor muscles and on symptoms of anal incontinence compared to&#xD;
      traditional biofeedback training; (3) To determine whether using the FLIP in the vagina is as&#xD;
      effective as its use in the anal canal for treatment of anal incontinence. To test these&#xD;
      aims, the approach includes a randomized controlled exercise trial with use of validated&#xD;
      measures of muscle function, muscle hypertrophy and validated symptom measures. This proposal&#xD;
      describes an innovative approach to rehabilitation of the pelvic floor muscles that will&#xD;
      provide information about pelvic floor function and that has the potential to shift the&#xD;
      treatment paradigm for women with pelvic floor disorders.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Length Tension Manometry after 12 weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>change from baseline to 12 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Muscle Hypertrophy (Ultrasound) after 12 weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>change from baseline to 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FISI score after 12 weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>change from baseline to 12 weeks</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Length Tension Manometry after 1 year</measure>
    <time_frame>12 months</time_frame>
    <description>change from baseline to 12 months</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Length Tension Manometry after 2 years</measure>
    <time_frame>24 months</time_frame>
    <description>change from baseline to 24 months</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Muscle Hypertrophy (ultrasound) after 1 year</measure>
    <time_frame>12 months</time_frame>
    <description>change from baseline to 12 months</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Muscle Hypertrophy (ultrasound) after 2 years</measure>
    <time_frame>24 months</time_frame>
    <description>change from baseline to 24 months</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in FISI score after 1 year</measure>
    <time_frame>12 months</time_frame>
    <description>change from baseline to 12 months</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in FISI score after 2 years</measure>
    <time_frame>24 months</time_frame>
    <description>change from baseline to 24 months</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Anal Incontinence</condition>
  <condition>Fecal Incontinence</condition>
  <arm_group>
    <arm_group_label>Eccentric Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Concentric Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Isometric Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Biofeedback</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Eccentric Training</intervention_name>
    <description>Different Anal Sphincter Exercise Types for muscle hypertrophy</description>
    <arm_group_label>Eccentric Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Concentric Training</intervention_name>
    <description>Different Anal Sphincter Exercise Types for muscle hypertrophy</description>
    <arm_group_label>Concentric Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Isometric Training</intervention_name>
    <description>Different Anal Sphincter Exercise Types for muscle hypertrophy</description>
    <arm_group_label>Isometric Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Biofeedback</intervention_name>
    <description>Standard of Care Biofeedback Training</description>
    <arm_group_label>Biofeedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  AI based on FISI questionnaire&#xD;
&#xD;
          -  FISI scores between 10 and 45&#xD;
&#xD;
          -  able to voluntarily contract pelvic floor muscles based on manometry measures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  FISI score below 10 (mild disease) or greater than 45 (severe disease)&#xD;
&#xD;
          -  manometry measure below the 10th percentile of normal (lack of muscle) or above 70th&#xD;
             percentile of normal (little room to improve strength)&#xD;
&#xD;
          -  history of large external hemorrhoids or history of bleeding hemorrhoids; co-existing&#xD;
             inflammatory bowel disease&#xD;
&#xD;
          -  constipation that is directly linked to neurological conditions such as spinal and&#xD;
             peripheral nerve pathologies&#xD;
&#xD;
          -  large pelvic organ prolapse (greater than stage 3)&#xD;
&#xD;
          -  inability to contract the pelvic floor muscles on command&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lori Tuttle, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Diego State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>October 24, 2022</last_update_submitted>
  <last_update_submitted_qc>October 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>San Diego State University</investigator_affiliation>
    <investigator_full_name>Lori Tuttle</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03252951
org study id: 141728
nct id: NCT03252951
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Anal incontinence is a significant public health problem estimated to affect 7-15% of women
      in the United States. Traditional rehabilitation strategies include biofeedback and Kegel
      exercises for pelvic floor muscle strengthening, but this strategy does not incorporate
      strategies for resistance training that are known to cause muscle strengthening and
      hypertrophy in other muscles in the body. This study aims to investigate whether a novel
      pelvic floor resistance exercise program will increase pelvic floor muscle strength and
      improve anal incontinence and has the potential to impact rehabilitation strategies for the
      millions of women affected anal incontinence.
The current proposal is focused on examining whether a novel resistance exercise program for
      the pelvic floor will strengthen pelvic floor muscles and improve symptoms in women with anal
      incontinence. Anal incontinence is a significant public health issue that is estimated to
      impact 7-15% of women. Traditional rehabilitation strategies such as Kegel exercises and
      biofeedback are a noninvasive strategy designed to strengthen the pelvic floor muscles,
      however, these exercises are performed with no resistance. There is a large body of evidence
      indicating that for muscle strengthening and hypertrophy to occur, exercises must be
      performed against resistance. Therefore, we have designed a novel exercise program for the
      pelvic floor that incorporates principals of resistance training known to be effective in
      other muscles in the body. The long-term goal of this research is to determine the most
      appropriate noninvasive strategies and interventions to improve pelvic floor function and
      symptoms of anal incontinence. This project is the first step in achieving this goal. The
      overall purpose of the current proposal is to determine whether novel physical therapy
      interventions are more effective than traditional biofeedback strategies in the treatment of
      anal incontinence. The specific aims of the proposal are: (1) To describe the use of the
      Functional Lumen Imaging Probe (FLIP) for pelvic floor exercise; (2) To determine whether
      eccentric, concentric, or isometric exercise training of the pelvic floor has a positive
      impact on the pelvic floor muscles and on symptoms of anal incontinence compared to
      traditional biofeedback training; (3) To determine whether using the FLIP in the vagina is as
      effective as its use in the anal canal for treatment of anal incontinence. To test these
      aims, the approach includes a randomized controlled exercise trial with use of validated
      measures of muscle function, muscle hypertrophy and validated symptom measures. This proposal
      describes an innovative approach to rehabilitation of the pelvic floor muscles that will
      provide information about pelvic floor function and that has the potential to shift the
      treatment paradigm for women with pelvic floor disorders.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Length Tension Manometry after 12 weeks
time frame: 12 weeks
description: change from baseline to 12 weeks
measure: Change in Muscle Hypertrophy (Ultrasound) after 12 weeks
time frame: 12 weeks
description: change from baseline to 12 weeks
measure: Change in FISI score after 12 weeks
time frame: 12 weeks
description: change from baseline to 12 weeks
measure: Change in Length Tension Manometry after 1 year
time frame: 12 months
description: change from baseline to 12 months
measure: Change in Length Tension Manometry after 2 years
time frame: 24 months
description: change from baseline to 24 months
measure: Change in Muscle Hypertrophy (ultrasound) after 1 year
time frame: 12 months
description: change from baseline to 12 months
measure: Change in Muscle Hypertrophy (ultrasound) after 2 years
time frame: 24 months
description: change from baseline to 24 months
measure: Change in FISI score after 1 year
time frame: 12 months
description: change from baseline to 12 months
measure: Change in FISI score after 2 years
time frame: 24 months
description: change from baseline to 24 months
arm group label: Eccentric Training
arm group type: Experimental
arm group label: Concentric Training
arm group type: Experimental
arm group label: Isometric Training
arm group type: Experimental
arm group label: Biofeedback
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Eccentric Training
description: Different Anal Sphincter Exercise Types for muscle hypertrophy
arm group label: Eccentric Training
intervention type: Behavioral
intervention name: Concentric Training
description: Different Anal Sphincter Exercise Types for muscle hypertrophy
arm group label: Concentric Training
intervention type: Behavioral
intervention name: Isometric Training
description: Different Anal Sphincter Exercise Types for muscle hypertrophy
arm group label: Isometric Training
intervention type: Behavioral
intervention name: Biofeedback
description: Standard of Care Biofeedback Training
arm group label: Biofeedback
criteria: 
gender: Female
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: Lori Tuttle, PT, PhD
role: Principal Investigator
affiliation: San Diego State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: San Diego State University
investigator full name: Lori Tuttle
investigator title: Associate Professor
mesh term: Fecal Incontinence
sharing ipd: No