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CTRI Number  CTRI/2025/08/092508 [Registered on: 06/08/2025] Trial Registered Prospectively
Last Modified On: 05/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Getting better results from Kegel exercises: How a "perineometer" strengthens muscles and reduces bladder leaks. 
Scientific Title of Study   Impact of perineometer guided Kegels exercises on pelvic floor strength and severity of symptoms in females with stress 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  Priyanka Ahire 
Designation  Co founder and Director 
Affiliation  Potentia Multispeciality Physiotherapy Clinic 
Address  Ratnavali,Row house no 2,Ecocity Pathardi Phata,Nashik
104,Buisness plus,Mumbai Naka 422002
Nashik
MAHARASHTRA
422010
India 
Phone  8971534771  
Fax    
Email  priyanka.ahire888@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Reema Joshi 
Designation  Professor 
Affiliation  Dr D Y Patil college of Physiotherapy  
Address  PuneDept of Physiothearapy,4th Floor,Y Patil College of Physiotherapy,Pimpri Chinchwad,Pune
Dept of Physiothearapy,4th Floor,Y Patil College of Physiotherapy,Pimpri Chinchwad,Pune
Pune
MAHARASHTRA
411018
India 
Phone  9890437630  
Fax    
Email  reema.joshi@dpu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Priyanka Ahire 
Designation  Co founder and Director  
Affiliation  Potentia Multispeciality Physiotherapy Clinic 
Address  Ratnavali,Row house no 2,Ecocity Pathardi Phata,Nashik
104,Buisness plus,Mumbai Naka 422002
Nashik
MAHARASHTRA
422010
India 
Phone  08971534771  
Fax    
Email  priyanka.ahire888@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Self 
Address  Buisness plus,Mumbai Naka,Nashik 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 0  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   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  NOT APPLICABLE   NOT APPLICABLE 
Intervention  Perineometer guided Kegels exercise   6 weeks session 2 sessions per week with home exercise programme will be given to the patient to carry out at home  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1 Participant willing to participate
2 Women within age group 35 to 45 diagnosed with stress incontinence
3 Incontinence Severity Index score 1 to 9
 
 
ExclusionCriteria 
Details  1 Participant with urge or mixed incontinence
2 Major medical illness like prolapse or cancer
3 Female with neurological bladder
4 Female with pregnancy
5 Acute Urinary Tract Infection
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 

Incontinence severity index
 
Baseline and 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Perineometer
1 hour pad test
Electromyography
Urinary Distress inventory
I-Quality of Life


 
Baseline & 6 weeks 
 
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 2 
Date of First Enrollment (India)   01/10/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Urinary incontinence is prevalent but underdiagnosed in Indian women. While physiotherapy’s efficacy for stress urinary incontinence (SUI) is established globally, limited Indian-specific evidence and low awareness hinder its implementation. Due to unique cultural, economic, and religious factors, there’s a need to develop and evaluate a tailored physiotherapy protocol for SUI in Indian women."

 

Women aged 35 to 45 are at a critical stage where early intervention can prevent the progression of stress urinary incontinence. This age group often experiences changes in pelvic floor muscle function due to factors such as childbirth and hormonal changes. Implementing perineometer-guided Kegel exercises can be particularly beneficial in this demographic, as it may help maintain pelvic floor health and prevent the onset or worsening of SUI.

 

The study of perineometer-guided Kegel exercises in women aged 35 to 45 is essential to establish effective, non-invasive interventions for managing and preventing stress urinary incontinence. By leveraging biofeedback technology, these exercises can be optimized to improve pelvic floor muscle strength and reduce incontinence symptoms, ultimately enhancing the quality of life for women in this age group.

 
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