<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/NCT02185235</url>
  </required_header>
  <id_info>
    <org_study_id>14MMHIS031</org_study_id>
    <nct_id>NCT02185235</nct_id>
  </id_info>
  <brief_title>A Randomized Controlled Trial of Electrical Stimulation to Treat Pelvic Floor Disorder</brief_title>
  <official_title>To Evaluate The Efficacy of Electrical Stimulation and Biofeedback Treatment for Pelvic Floor Disorder Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mackay Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mackay Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Female pelvic floor disorders (PFDs) include urinary incontinence,pelvic organ prolapse&#xD;
      (POP), and fecal incontinence-which often occur together.&#xD;
&#xD;
      Pelvic floor disorders impair multiple aspects of the life quality, including the sexual&#xD;
      function of women.&#xD;
&#xD;
      Surgery became the first choice of treatment, however, and not until 1980s was the renewed&#xD;
      interest in conservative therapies.&#xD;
&#xD;
      This may be because of higher awareness among women and cost of and morbidity after surgery.&#xD;
&#xD;
      The conservative treatment included pelvic floor muscle training, electrical stimulation,&#xD;
      vaginal cones, and biofeedback.&#xD;
&#xD;
      The outcome was up to 35~70 % improved rate as the literature before. Current guidelines&#xD;
      recommended conservative management as a first-line therapy. However, there was no consistent&#xD;
      consensus on this issue due to variations in stimulation parameters、adjuvant concurrent&#xD;
      modality or duration of treatment course, and insufficient result about large and long term&#xD;
      follow up of randomized- controlled studies.&#xD;
&#xD;
      Therefore, the investigators try to conduct one randomized-controlled trial to evaluate the&#xD;
      efficacy of conservative treatment for Pelvic floor disorder (Pelvic organ prolapse, urinary&#xD;
      incontinence, chronic pelvic pain etc.).&#xD;
&#xD;
      At the aspect of Quality of life, our studies tried to focus on the different domains of&#xD;
      pelvic disorder and sexual quality by means of validated questionnaire more objectively.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">May 2025</completion_date>
  <primary_completion_date type="Anticipated">June 2024</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>
  </study_design_info>
  <primary_outcome>
    <measure>1-Hour Pad test of urine leakage amount (gm)</measure>
    <time_frame>Total 18 times of treatment, for 3 months</time_frame>
    <description>A pad test is a tool to used to measure urine leakage amount . Pad testing can be done over a period of time to one hour.&#xD;
A sanitary napkin is weighed and then worn for sixty minutes, during which time the individual is asked to perform certain activities which may include:&#xD;
Walking briskly for three minutes&#xD;
Sitting and then standing ten to twenty times&#xD;
Walking up and down stairs for one to two minutes&#xD;
Picking up objects from the floor five to ten times&#xD;
Coughing twelve times (at various strengths; may be repeated)&#xD;
Running in place for one minute (may be repeated) The pad is then removed and weighed again to calculate the amount of urine voided.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life (score)</measure>
    <time_frame>Total 18 times of treatment, for 3 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Vaginal pressure (mmHg)</measure>
    <time_frame>Total 18 times of treatment, for 3 months</time_frame>
    <description>Use the vaginal probe sensor to evaluate the objective level of vaginal squeezing pressure and endurance time</description>
  </other_outcome>
  <other_outcome>
    <measure>Urodynamics data analysis</measure>
    <time_frame>Total 18 times of treatment, for 3 months</time_frame>
    <description>Use urodyanmic examinations for evaluation of bladder function</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <condition>Incontinence</condition>
  <arm_group>
    <arm_group_label>Biofeedback &amp; Electrical Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twice a week, 20 minutes for each time. One course includes 18 times treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biofeedback &amp; Pelvic Floor Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pelvic floor training every 20 minutes for each time, twice a week. and total for 18 times.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electrical Stimulation</intervention_name>
    <description>The Chartered Society of Physiotherapy recommends the following standard for electrical devices.&#xD;
Frequency: 35 Hertz. Pulse width: 250µs (0.25ms). Current type: bi-phasic rectangular. Intensity: maximum tolerated. Duty-cycle: 5 seconds on/10 seconds off. Very weak muscles: 5 seconds on/15 seconds off.&#xD;
Treatment time: 5 minutes initially, gradually increasing to 20 minutes.</description>
    <arm_group_label>Biofeedback &amp; Electrical Stimulation</arm_group_label>
    <other_name>Femiscan Stim (Mega Electronics Ltd)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biofeedback</intervention_name>
    <description>Biofeedback is a treatment technique in which people are trained to improve their health by using signals from their own bodies</description>
    <arm_group_label>Biofeedback &amp; Electrical Stimulation</arm_group_label>
    <arm_group_label>Biofeedback &amp; Pelvic Floor Training</arm_group_label>
    <other_name>Femiscan Multi-trainer</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pelvic Floor Training</intervention_name>
    <description>First, as you are sitting or lying down, try to contract the muscles you would use to stop urinating To contract the pelvic muscles, squeeze for 3 seconds and then relax for 3 seconds.&#xD;
Repeat this exercise to 20 minutes each session.</description>
    <arm_group_label>Biofeedback &amp; Pelvic Floor Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal&#xD;
             incontinence.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is pregnant The patient had any major medical or psychiatric disease The&#xD;
             patient with Metabolic medical device&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>TSUNG H Su, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mackay Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tsung-Hsien Su, PhD</last_name>
    <phone>886-25433535</phone>
    <phone_ext>2544</phone_ext>
    <email>drthsu@mail.itrip.com.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Taiwan, Taipei, Mackay Memorial hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>November 2, 2022</last_update_submitted>
  <last_update_submitted_qc>November 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mackay Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Tsung-Hsien Su</investigator_full_name>
    <investigator_title>Mackay Memorial Hospital</investigator_title>
  </responsible_party>
  <keyword>Electrical stimulation</keyword>
  <keyword>Biofeedback</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pelvic Floor Disorders</mesh_term>
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</mesh_term>
  </condition_browse>
  <!-- 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/NCT02185235
org study id: 14MMHIS031
nct id: NCT02185235
lead sponsor: 
has dmc: Yes
Female pelvic floor disorders (PFDs) include urinary incontinence,pelvic organ prolapse
      (POP), and fecal incontinence-which often occur together.

      Pelvic floor disorders impair multiple aspects of the life quality, including the sexual
      function of women.

      Surgery became the first choice of treatment, however, and not until 1980s was the renewed
      interest in conservative therapies.

      This may be because of higher awareness among women and cost of and morbidity after surgery.

      The conservative treatment included pelvic floor muscle training, electrical stimulation,
      vaginal cones, and biofeedback.

      The outcome was up to 35~70 % improved rate as the literature before. Current guidelines
      recommended conservative management as a first-line therapy. However, there was no consistent
      consensus on this issue due to variations in stimulation parameters、adjuvant concurrent
      modality or duration of treatment course, and insufficient result about large and long term
      follow up of randomized- controlled studies.

      Therefore, the investigators try to conduct one randomized-controlled trial to evaluate the
      efficacy of conservative treatment for Pelvic floor disorder (Pelvic organ prolapse, urinary
      incontinence, chronic pelvic pain etc.).

      At the aspect of Quality of life, our studies tried to focus on the different domains of
      pelvic disorder and sexual quality by means of validated questionnaire more objectively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: 1-Hour Pad test of urine leakage amount (gm)
time frame: Total 18 times of treatment, for 3 months
description: A pad test is a tool to used to measure urine leakage amount . Pad testing can be done over a period of time to one hour.
A sanitary napkin is weighed and then worn for sixty minutes, during which time the individual is asked to perform certain activities which may include:
Walking briskly for three minutes
Sitting and then standing ten to twenty times
Walking up and down stairs for one to two minutes
Picking up objects from the floor five to ten times
Coughing twelve times (at various strengths; may be repeated)
Running in place for one minute (may be repeated) The pad is then removed and weighed again to calculate the amount of urine voided.
measure: Quality of life (score)
time frame: Total 18 times of treatment, for 3 months
measure: Vaginal pressure (mmHg)
time frame: Total 18 times of treatment, for 3 months
description: Use the vaginal probe sensor to evaluate the objective level of vaginal squeezing pressure and endurance time
measure: Urodynamics data analysis
time frame: Total 18 times of treatment, for 3 months
description: Use urodyanmic examinations for evaluation of bladder function
arm group label: Biofeedback & Electrical Stimulation
arm group type: Experimental
description: Twice a week, 20 minutes for each time. One course includes 18 times treatment.
arm group label: Biofeedback & Pelvic Floor Training
arm group type: Active Comparator
description: Pelvic floor training every 20 minutes for each time, twice a week. and total for 18 times.
intervention type: Device
intervention name: Electrical Stimulation
description: The Chartered Society of Physiotherapy recommends the following standard for electrical devices.
Frequency: 35 Hertz. Pulse width: 250µs (0.25ms). Current type: bi-phasic rectangular. Intensity: maximum tolerated. Duty-cycle: 5 seconds on/10 seconds off. Very weak muscles: 5 seconds on/15 seconds off.
Treatment time: 5 minutes initially, gradually increasing to 20 minutes.
arm group label: Biofeedback & Electrical Stimulation
other name: Femiscan Stim (Mega Electronics Ltd)
intervention type: Device
intervention name: Biofeedback
description: Biofeedback is a treatment technique in which people are trained to improve their health by using signals from their own bodies
arm group label: Biofeedback & Electrical Stimulation
arm group label: Biofeedback & Pelvic Floor Training
other name: Femiscan Multi-trainer
intervention type: Other
intervention name: Pelvic Floor Training
description: First, as you are sitting or lying down, try to contract the muscles you would use to stop urinating To contract the pelvic muscles, squeeze for 3 seconds and then relax for 3 seconds.
Repeat this exercise to 20 minutes each session.
arm group label: Biofeedback & Pelvic Floor Training
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: TSUNG H Su, Professor
role: Principal Investigator
affiliation: Mackay Memorial Hospital
last name: Tsung-Hsien Su, PhD
phone: 886-25433535
phone ext: 2544
email: drthsu@mail.itrip.com.tw
facility: 
status: Recruiting
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Mackay Memorial Hospital
investigator full name: Tsung-Hsien Su
investigator title: Mackay Memorial Hospital
mesh term: Pelvic Floor Disorders
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse