<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/NCT04477265</url>
  </required_header>
  <id_info>
    <org_study_id>105019 - F</org_study_id>
    <nct_id>NCT04477265</nct_id>
  </id_info>
  <brief_title>Efficacy of Biofeedback PFMT and Medication in Women With Overactive Bladder</brief_title>
  <acronym>PFMT</acronym>
  <official_title>Efficacy of of Pelvic Floor Muscle Training( PFMT ) With Surface Electromyographic Biofeedback and Medication in Women With Overactive Bladder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Far Eastern Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Far Eastern Memorial Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Medical treatment for overactive bladder is acceptable widely. However, the effect of drug&#xD;
      treatment is different due to compliance and side effect of the drug. Biofeedback-assisted&#xD;
      pelvic floor muscle training (PFMT) is the first line recommendation for overactive bladder.&#xD;
      The slow effect of biofeedback-assisted pelvic floor muscle training leads to low motivation&#xD;
      for continuous treatment and results in compliance difference. This slow effect also changes&#xD;
      the degree of improvement in the treatment of overactive bladder. This study is designed to&#xD;
      evaluate the efficacy of combination therapy for treatment of female overactive bladder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participant will be prescribed with oral medication in combination with biofeedback-assisted&#xD;
      pelvic floor muscle training (PFMT) for the first month. Participant will continue to have&#xD;
      biofeedback assisted PFMT for another two months without oral medication. The investigators&#xD;
      expected that combination therapy will improve the compliance and severity of symptoms in&#xD;
      women with overactive bladder.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 16, 2016</start_date>
  <completion_date type="Actual">December 24, 2021</completion_date>
  <primary_completion_date type="Actual">December 24, 2021</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>
    <intervention_model_description>A total of 210 women with overactive bladder will be recruited and randomized to 3 arms: drug only, exercise only and combination arm.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>3-Day Voiding Diary</measure>
    <time_frame>Baseline through study completion, an average of 12 weeks.</time_frame>
    <description>to record urinary output, fluid consumed, and urinary leakage (if applicable) for 3 complete 24-hour periods (they do not have to be consecutive days).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom Distress scale(SDS)</measure>
    <time_frame>through study completion, an average of 12 weeks.</time_frame>
    <description>the degree of discomfort from the specific symptoms being experienced, as perceived by the participants, consists of 23 items.The scale scored between 1 (best) and 5 (worst) .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change of electromyographic activity</measure>
    <time_frame>through study completion, an average of 12 weeks.</time_frame>
    <description>Electromyographic activity of the pelvic floor muscles (PFMs) and the synergistic abdominal muscles (SAMs) during each session of PFMT(µV)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>King's Health Questionnaire (KHQ)</measure>
    <time_frame>through study completion, an average of 12 weeks.</time_frame>
    <description>KHQ has 3 parts consisting of 21 items. Part 1 contains general health perception and incontinence impact (one item each). Part 2 contains role limitations, physical limitations, social limitations (two items each), personal relationships, emotions (three items each) and sleep/energy (two items), severity measures (four items).Part 3 is considered as a single item and contains ten responses in relation to frequency, nocturia, urgency,urge, stress, intercourse incontinence, nocturnal enuresis,infections, pain, and difficulty in voiding. The 4 subscales scored between 1 (best) and 4 (worst) in part 1 and 2. The Symptom Severity scale is scored from 0 (best) to 3 (worst) in part 3 .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>A five-item Self-Assessment of Treatment (SAT)</measure>
    <time_frame>through study completion, an average of 12 weeks.</time_frame>
    <description>to assess improvement and satisfaction with treatment, consists of 1 item. The scale scored between 1 (worst) and 5 (best ) .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>A five-item Self-Assessment of Self-efficacy</measure>
    <time_frame>through study completion, an average of 12 weeks.</time_frame>
    <description>to assess motivation with PFMT, consists of 14 items.The scale scored between 1 (worst) and 6(best) .</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Overactive Bladder</condition>
  <arm_group>
    <arm_group_label>combination of drug and exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant will be prescribed with oral medication in combination with biofeedback-assisted pelvic floor muscle training (PFMT) during the first month, participant will continue to have biofeedback assisted PFMT for another 2 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>drug only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participant will be prescribed with oral medication for 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>exercise only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participant will be doing biofeedback-assisted pelvic floor muscle training for 3 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Solifenacin Succinate 5mg/tab daily</intervention_name>
    <description>participants will be taking oral medication for 3 months</description>
    <arm_group_label>combination of drug and exercise</arm_group_label>
    <arm_group_label>drug only</arm_group_label>
    <other_name>Vesicare 5mg/tab daily</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>biofeedback-assisted pelvic floor muscle training</intervention_name>
    <description>participants will be doing biofeedback-assisted pelvic floor muscle training for 3 months</description>
    <arm_group_label>combination of drug and exercise</arm_group_label>
    <arm_group_label>exercise only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. overactivity bladder for more than 3 months&#xD;
&#xD;
          2. more then 20 year old,less then 85 year old and acceptable to receive vaginal&#xD;
             examination&#xD;
&#xD;
          3. need to match schedule with the investigator's clinic for 5 times,followed by&#xD;
             individual therapy, each takes about 30 to 60 minutes, a total of 12 weeks of pelvic&#xD;
             floor muscle exercises&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Suffering from systemic neuromuscular diseases, such as stroke, spinal cord injury,&#xD;
             peripheral neuropathy, etc.&#xD;
&#xD;
          2. Glaucoma&#xD;
&#xD;
          3. Kidney disease&#xD;
&#xD;
          4. Liver disease&#xD;
&#xD;
          5. Patients with cardiac rhythm devices.&#xD;
&#xD;
          6. Insufficient cognitive function, unable to cooperate with pelvic floor muscle&#xD;
             exercises.&#xD;
&#xD;
          7. Women during pregnancy.&#xD;
&#xD;
          8. Maternity within six weeks after delivery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wen-Yih Wu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Far Eastern Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Far Eastern Memorial Hospital</name>
      <address>
        <city>New Taipei City</city>
        <zip>220</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>January 26, 2022</last_update_submitted>
  <last_update_submitted_qc>January 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Overactive</keyword>
  <keyword>drug only</keyword>
  <keyword>exercise only</keyword>
  <keyword>combination of drug and exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Solifenacin Succinate</mesh_term>
  </intervention_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/NCT04477265
org study id: 105019 - F
nct id: NCT04477265
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Medical treatment for overactive bladder is acceptable widely. However, the effect of drug
      treatment is different due to compliance and side effect of the drug. Biofeedback-assisted
      pelvic floor muscle training (PFMT) is the first line recommendation for overactive bladder.
      The slow effect of biofeedback-assisted pelvic floor muscle training leads to low motivation
      for continuous treatment and results in compliance difference. This slow effect also changes
      the degree of improvement in the treatment of overactive bladder. This study is designed to
      evaluate the efficacy of combination therapy for treatment of female overactive bladder.
Participant will be prescribed with oral medication in combination with biofeedback-assisted
      pelvic floor muscle training (PFMT) for the first month. Participant will continue to have
      biofeedback assisted PFMT for another two months without oral medication. The investigators
      expected that combination therapy will improve the compliance and severity of symptoms in
      women with overactive bladder.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A total of 210 women with overactive bladder will be recruited and randomized to 3 arms: drug only, exercise only and combination arm.
primary purpose: Treatment
masking: None (Open Label)
measure: 3-Day Voiding Diary
time frame: Baseline through study completion, an average of 12 weeks.
description: to record urinary output, fluid consumed, and urinary leakage (if applicable) for 3 complete 24-hour periods (they do not have to be consecutive days).
measure: Symptom Distress scale(SDS)
time frame: through study completion, an average of 12 weeks.
description: the degree of discomfort from the specific symptoms being experienced, as perceived by the participants, consists of 23 items.The scale scored between 1 (best) and 5 (worst) .
measure: change of electromyographic activity
time frame: through study completion, an average of 12 weeks.
description: Electromyographic activity of the pelvic floor muscles (PFMs) and the synergistic abdominal muscles (SAMs) during each session of PFMT(µV)
measure: King's Health Questionnaire (KHQ)
time frame: through study completion, an average of 12 weeks.
description: KHQ has 3 parts consisting of 21 items. Part 1 contains general health perception and incontinence impact (one item each). Part 2 contains role limitations, physical limitations, social limitations (two items each), personal relationships, emotions (three items each) and sleep/energy (two items), severity measures (four items).Part 3 is considered as a single item and contains ten responses in relation to frequency, nocturia, urgency,urge, stress, intercourse incontinence, nocturnal enuresis,infections, pain, and difficulty in voiding. The 4 subscales scored between 1 (best) and 4 (worst) in part 1 and 2. The Symptom Severity scale is scored from 0 (best) to 3 (worst) in part 3 .
measure: A five-item Self-Assessment of Treatment (SAT)
time frame: through study completion, an average of 12 weeks.
description: to assess improvement and satisfaction with treatment, consists of 1 item. The scale scored between 1 (worst) and 5 (best ) .
measure: A five-item Self-Assessment of Self-efficacy
time frame: through study completion, an average of 12 weeks.
description: to assess motivation with PFMT, consists of 14 items.The scale scored between 1 (worst) and 6(best) .
arm group label: combination of drug and exercise
arm group type: Experimental
description: Participant will be prescribed with oral medication in combination with biofeedback-assisted pelvic floor muscle training (PFMT) during the first month, participant will continue to have biofeedback assisted PFMT for another 2 months
arm group label: drug only
arm group type: Active Comparator
description: Participant will be prescribed with oral medication for 3 months
arm group label: exercise only
arm group type: Active Comparator
description: Participant will be doing biofeedback-assisted pelvic floor muscle training for 3 months
intervention type: Drug
intervention name: Solifenacin Succinate 5mg/tab daily
description: participants will be taking oral medication for 3 months
arm group label: combination of drug and exercise
arm group label: drug only
other name: Vesicare 5mg/tab daily
intervention type: Behavioral
intervention name: biofeedback-assisted pelvic floor muscle training
description: participants will be doing biofeedback-assisted pelvic floor muscle training for 3 months
arm group label: combination of drug and exercise
arm group label: exercise only
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Wen-Yih Wu
role: Principal Investigator
affiliation: Far Eastern Memorial Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Urinary Bladder, Overactive
mesh term: Solifenacin Succinate