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CTRI Number  CTRI/2025/07/091661 [Registered on: 24/07/2025] Trial Registered Prospectively
Last Modified On: 17/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Lifestyle and Exercise Program for Women with Urinary Leakage: A Community-Based Study 
Scientific Title of Study   Effectiveness of Community Based Rehabilitation Program Endorsed with lifestyle modification and Pelvic Floor Muscle Training in women with Stress Urinary Incontinence 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Moon Sutradhor 
Designation  Undergraduate Student 
Affiliation  Jashore University of Science and Technology 
Address  Room no 304, department of Physiotherapy and Rehabilitation, Jashore university of science and Technology



7408
Other 
Phone  8801963491840  
Fax    
Email  moonsutradhor@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Md Feroz Kabir 
Designation  Assistant Professor 
Affiliation  Jashore University of Science and Technology 
Address  Room no 409, department of Physiotherapy and Rehabilitation, Jashore university of science and Technology



7408
Other 
Phone  8801765932545  
Fax    
Email  feroz@just.edu.bd  
 
Details of Contact Person
Public Query  
Name  Dr Md Feroz Kabir 
Designation  Assistant Professor 
Affiliation  Jashore University of Science and Technology 
Address  Room no 409, department of Physiotherapy and Rehabilitation, Jashore university of science and Technology



7408
Other 
Phone  8801765932545  
Fax    
Email  feroz@just.edu.bd  
 
Source of Monetary or Material Support  
Department of Physiotherapy and Rehabilitation, Jashore University Of science and Technology, Jashore 7408, Bangladesh 
 
Primary Sponsor  
Name  Dr Ehsanur Rahman 
Address  Room no 401, Jashore University of Science and Technology 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Bangladesh  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ehsanur Rahman  Dr MR Khan Medical Centre  Level 3, Room no 301, Musculoskeletal lab, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore 7408, Bangladesh

 		 8801716062263

chairman.ptr@just.edu.bd 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IRB of Department of Physiotherapy and Rehabilitation, JUST  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N393||Stress incontinence (female) (male),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Health Education  Basic Health Education will be given 
Intervention  Pelvic Floor Muscle Training and Lifestyle modification  PFMT: PFMT intervention will be given for stress urinary incontinence 3/4 times per week(30mins), there will be 4 weeks of intervention. • Lifestyle modification  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Women aged 18-60 years
Diagnosed with Stress Urinary Incontinence (confirmed by a Clinician)
Willing to participate & give informed consent

 
 
ExclusionCriteria 
Details  Urge or Mixed incontinence
Pregnant women
Recent pelvic Surgery (within 6 months)
Severe cognitive or physical disability
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction of urinary leakage measured by 1 hour pad test  6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Pelvic floor muscle strength by perineometer  6 weeks 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="0" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/07/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [feroz@just.edu.bd].

  6. For how long will this data be available start date provided 25-02-2026 and end date provided 12-03-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This randomized controlled trial aims to evaluate the effectiveness of a Community Based Rehabilitation program combined with lifestyle modification and pelvic floor muscle training in managing stress urinary incontinence among women aged 18 to 60 years. Participants will be randomly allocated into intervention and control groups. The intervention group will receive structured pelvic floor muscle training along with lifestyle education through a community based approach, delivered three times per week for six weeks. Outcomes will be measured using objective tools such as the one hour pad test, perineometer, bladder diary, and the International Consultation on Incontinence Questionnaire, assessing improvements in urinary leakage and pelvic floor muscle strength. This study seeks to provide evidence on the role of community level rehabilitation in improving quality of life and continence outcomes in women with stress urinary incontinence. 
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