| CTRI Number |
CTRI/2026/01/101221 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Awareness and Exercises for Pelvic Floor Health in Rural Women with Urinary Incontinence-A quasi experimental study
|
|
Scientific Title of Study
|
Improving Pelvic Health Awareness and Reducing Urinary Incontinence Among Rural Women Through Pelvic Floor Education, Awareness, Rehabilitation and Lifestyle Modification Program – 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 |
DrMadhura Prasad Damkondewar PT |
| Designation |
Masters of Community Physiotherapy Student |
| Affiliation |
Maharashtra Institute of Physiotherapy,Latur |
| Address |
Department of Community Physiotherapy, OPD G14,Maharashtra Institute of Physiotherapy,MIMSR medical campus,Ambajogai Road, Latur
Department of Community Physiotherapy, OPD G14,Maharashtra Institute of Physiotherapy,MIMSR medical campus,Ambajogai Road, Latur
Latur
MAHARASHTRA
513531
India |
| Phone |
7385890775 |
| Fax |
|
| Email |
mdamkonde@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeetha M |
| Designation |
Professor of Community Physiotherapy |
| Affiliation |
Department of Community Physiotherapy, OPD G14,Maharashtra Institute of Physiotherapy,MIMSR medical campus,Ambajogai Road, Latur |
| Address |
Department of Community Physiotherapy, OPD G14,Maharashtra Institute of Physiotherapy,MIMSR medical campus,Ambajogai Road, Latur
Department of Community Physiotherapy, OPD G14,Maharashtra Institute of Physiotherapy,MIMSR medical campus,Ambajogai Road, Latur
Latur
MAHARASHTRA
513531
India |
| Phone |
9842827771 |
| Fax |
|
| Email |
saisangeetha2621@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sangeetha M |
| Designation |
Professor of Community Physiotherapy |
| Affiliation |
Department of Community Physiotherapy, OPD G14,Maharashtra Institute of Physiotherapy,MIMSR medical campus,Ambajogai Road, Latur |
| Address |
Department of Community Physiotherapy, OPD G14,Maharashtra Institute of Physiotherapy,MIMSR medical campus,Ambajogai Road, Latur
Department of Community Physiotherapy, OPD G14,Maharashtra Institute of Physiotherapy,MIMSR medical campus,Ambajogai Road, Latur
Latur
MAHARASHTRA
513531
India |
| Phone |
9842827771 |
| Fax |
|
| Email |
saisangeetha2621@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharashtra Institute of Department of Community Physiotherapy, Maharashtra Institute of Physiotherapy, MIMSR Medical Campus,Ambajogai Road, Latur. |
|
|
Primary Sponsor
|
| Name |
Maharashtra Institute of Physiotherapy, Latur |
| Address |
Maharashtra Institute of Physiotherapy,MIMSR Medical Campus, Ambajogai road,Latur 413531 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrMadhura Prasad Damkondewar |
Maharashtra Institute Of Physiotherapy,Latur |
Department of Community Physiotherapy,OPD-G14,Maharashtra Institute of Physiotherapy, MIMSR Medical Campus,Ambajogai Road, Latur, Maharashtra 513531
Latur
MAHARASHTRA |
7385890775
mdamkonde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committeeof Maharashtra institute of Physiotherapy,Latur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Structured Exercise program
(PEARL-Pelvic Floor Education, Awareness, Rehabilitation, and Lifestyle Modification Program)
|
This program will be carried out over 8 weeks.
1)Education : a)1st session includes information about urinary incontinence causes and risk factors, what are the pelvic floor muscles and their functions.
2)Awareness : a))About kegel exercises its benefits and its benefits.
b)Treatment seeking behavior.
d)How to use facilities for urination control
3)Pelvic floor muscle training
a)Kegel exercices
b)Deep breathing exercises
4)Life style modification :
a)The use of anticipatory pelvic floor muscle contraction
b)Inhibition of Urinary Incontinence
c)Diet modification
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1 Age 20-60 years.
2 Woman presents with a new episode of Urinary incontinence.
3 Women diagnosed with UI (stress, urge, or mixed).
4 Ability to understand and follow instructions for pelvic floor muscle training (PFMT).3
5 Willingness to participate in the full duration of the study.
6 Women residing at rural areas.
|
|
| ExclusionCriteria |
| Details |
1.Woman has received formal PFMT instruction in the previous year (e.g. from a physiotherapist)
2.Pregnant women.
3.Pelvic organ prolapses.
4.Neurological diseases affecting bladder function.
5.Urinary tract infections.
6.Patients undergone recent abdominal surgeries.
7.Cognitive impairment affecting ability to follow instructions
8.Physical disability preventing participation in the exercises.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)1) International Consultation on Incontinence Questionnaire- (ICIQ-UI SF)
2)Oxford Grading Scale |
Baseline
After 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1)King’s Health Questionnaire |
Baseline
After 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
29/01/2026 |
| 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 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
|
Improving Pelvic Health Awareness and Reducing Urinary Incontinence Among Rural Women Through Pelvic Floor Education Awareness Rehabilitation and Lifestyle Modification Program A Quasi Experimental Study The study focuses on women aged 20 to 60 years living in rural areas who suffer from involuntary urine loss This condition affects 32% of rural women in India but many remain silent due to social stigma or lack of funds The PEARL Program involves an 8 week intervention including Education on pelvic anatomy and risk factors like obesity or childbirth Awareness sessions to encourage seeking treatment and reducing embarrassment Rehabilitation using Kegel exercises with increasing hold times and deep breathing Lifestyle changes like the Knack principle and reducing caffeine or night time water intake Success is measured using the International Consultation on Incontinence Questionnaire the Kings Health Questionnaire for quality of life and the Oxford Grading Scale for muscle strength The goal is to prove that structured education and exercise significantly improve pelvic health and reduce symptoms |