| 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
|
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Buisness plus,Mumbai Naka,Nashik |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
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
|
|
|
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. |