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CTRI Number  CTRI/2025/06/089753 [Registered on: 27/06/2025] Trial Registered Prospectively
Last Modified On: 25/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Improving Pelvic Floor Strength and Reducing Urine Leakage in Postmenopausal Women Using Hypopressive Exercises 
Scientific Title of Study   Effects of hypopressive exercise on pelvic floor strength and severity of incontinence in postmenopausal women with stress urinary incontinence: A Quasi experimental study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shivani Harshwardhan Vaidya 
Designation  Post graduate student  
Affiliation  Dr D Y Patil college of physiotherapy pune 
Address  Dr D Y Patil college of Physiotherapy Sant Tukaram Nagar Pimpri Colony Pimpri Pune411018
Dr D Y Patil college of Physiotherapy Sant Tukaram Nagar Pimpri Colony Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India 
Phone  8421332391  
Fax    
Email  vaidyashivani04@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Reema Joshi  
Designation  Professor  
Affiliation  Dr D Y Patil college of physiotherapy pune 
Address  Dr D Y Patil college of Physiotherapy Sant Tukaram Nagar Pimpri Colony Pimpri Pune 411018
Dr D Y Patil college of Physiotherapy Sant Tukaram Nagar Pimpri Colony Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India 
Phone  9890437630  
Fax    
Email  reema.joshi@dpu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Reema Joshi  
Designation  Professor  
Affiliation  Dr D Y Patil college of physiotherapy pune 
Address  Dr D Y Patil college of Physiotherapy Sant Tukaram Nagar Pimpri Colony Pimpri Pune 411018
Dr D Y Patil college of Physiotherapy Sant Tukaram Nagar Pimpri Colony Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India 
Phone  9890437630  
Fax    
Email  reema.joshi@dpu.edu.in  
 
Source of Monetary or Material Support  
Dr D Y Patil college of physiotherapy Sant Tukaram Nagar Pimpri Colony Pimpri-Chinvhwad, Maharashtra,411018 
 
Primary Sponsor  
Name  Shivani Harshwardhan Vaidya 
Address  Dr D Y Patil college of physiotherapy Sant Tukaram Nagar Pimpri Colony Pimpri-Chinvhwad, Maharashtra,411018 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shivani Harshwardhan Vaidya  Dr D Y Patil physiotherapy OPD  Dr D Y Patil college of Physiotherapy Sant Tukaram Nagar Pimpri Colony PimpriPune
Pune
MAHARASHTRA 		 08421332391

vaidyashivani04@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr D Y Patil College of Physiotheraphy Pune  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 
Intervention  Hypopressive exercises  Ethical approval will be taken from Institutional Ethical Committee After approval from ethical committee clinical trial registration will be done under CTRI Subjects reporting to OPD with Stress Urinary Incontinence after post-menopause will be screened those who are fulfilling I conclusion and exclusion criteria will be included in the study Subjects will be explained about study procedure and those who are willing to participate, written informed consent will be taken and subjects will be recruited. Group of the participants will get Hypopressive exercises along with PFMT exercises Treatment will be given for 6weeks, 4 times a week i.e. 24 sessions in total. Assessment and outcome measures will be done pre and post treatment plan. After completing data collection, statistical analysis will be done  
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1. Post-menopausal women aged 45 years 65 years
2. Those who are having stress urinary incontinence symptoms since six months and more
3. At least 12 months of amenorrhoea duration of stress urinary incontinence symptoms.
4. Patients who have signed an informed consent form.
Stress urinary in continence of grade 1 and grade 2.
 
 
ExclusionCriteria 
Details  1. Women under 45 years of age
2. Women with urge urinary incontinence, mixed urinary incontinence, or overflow incontinence should not be included in the study.
3. Women with significant pelvic organ prolapse that could interfere with the study
4. Women with neurological conditions such as multiple sclerosis Parkinsons disease or stroke that could affect bladder function
5. Women with hypertension and hiatus hernia and recent abdominal surgery
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
i) STOP Test
ii) Frequency Volume Test
iii) Incontinence Impact Questionnaire (IIQ)
iv) Cough- Stress Test 		 baseline assessment and post-intervention assessment after 6 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 1 
Date of First Enrollment (India)   10/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Title: Effects of hypopressive exercises on strength of pelvic floor muscles and severity of incontinence in postmenopausal women with stressed urinary incontinence: A Quasi experimental study

Study Design:

  • Design Type: Single-arm prospective interventional study

  • Location: Outpatient Department, Dr. D. Y. Patil College of Physiotherapy, Pune

  • Duration: 6 weeks (3 sessions/week, 30 minutes each)

Objective:

To evaluate the effectiveness of hypopressive exercises on:

  • Pelvic floor muscle strength

  • Severity of stress urinary incontinence (SUI)

  • Quality of life in postmenopausal women

Participants:

  • Target Group: Postmenopausal women aged 45–65 years

This single-arm prospective interventional study was conducted at the Outpatient Department of Dr. D. Y. Patil College of Physiotherapy, Pune, to evaluate the effectiveness of hypopressive exercises in managing stress urinary incontinence (SUI) among postmenopausal women. The study included postmenopausal women aged between 45 and 65 years who had been experiencing symptoms of SUI for at least six months. Over a 6-week intervention period, participants received hypopressive exercise sessions three times a week, with each session lasting 30 minutes. The primary objectives of the study were to assess improvements in pelvic floor muscle strength, reduction in the severity of urinary incontinence, and enhancement in the participants’ quality of life. Outcome measures included the STOP test, Frequency/Volume chart, Incontinence Impact Questionnaire (IIQ), and the Cough Stress Test. All assessments were conducted pre- and post-intervention to determine the clinical effectiveness of the hypopressive exercise program. This study aimed to provide evidence for the potential role of hypopressive training as a non-invasive therapeutic strategy for improving pelvic health in postmenopausal women with stress urinary incontinence.


 
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