| CTRI Number |
CTRI/2025/07/090368 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [occupational therapy] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Healthy Bladder Habits and pelvic floor muscle training on Urinary Incontinence in old age women |
|
Scientific Title of Study
|
Effect of Healthy Bladder Habits and Pelvic Floor Muscle Training on Urinary Incontinence in Women aged above 50 years |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr PRITI TAYADE |
| Designation |
Post Graduate Student in Occupational Therapy |
| Affiliation |
LTMMC and Sion Hospital, Mumbai |
| Address |
OT Training School and Centre LTMMC and GH Sion, West , Mumbai, Maharashtra
OT Training School and Centre LTMMC and GH Sion, West , Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9518709752 |
| Fax |
|
| Email |
tayadedrpriti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuradha Pai |
| Designation |
Asst Professor |
| Affiliation |
LTMMC and Sion Hospital, Mumbai |
| Address |
OT Training School and Centre LTMMC and GH Sion, West , Mumbai, Maharashtra
OT Training School and Centre LTMMC and GH Sion, West , Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9820661856 |
| Fax |
|
| Email |
suchanu@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuradha Pai |
| Designation |
Asst Professor |
| Affiliation |
LTMMC and Sion Hospital, Mumbai |
| Address |
OT Training School and Centre LTMMC and GH Sion, West , Mumbai, Maharashtra
OT Training School and Centre LTMMC and GH Sion, West , Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9820661856 |
| Fax |
|
| Email |
suchanu@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
OT Training School and Centre LTMMC and GH |
| Address |
OT Training School and Centre LTMMC and GH Laxmibai Kelkar road SION Mumbai Maharashtra 400022 India |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Priti Tayade |
LTMMC and GH |
OT Training Centre and School LTMMC and GH, Dr Babasaheb ambedkar road, mortuary building 5th floor,OPD 23 sion mumbai
Mumbai (Suburban)
MAHARASHTRA |
9518709752
tayadedrpriti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Human Research, Lokmanya Tilak Municipal Medical College and General Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Urinary Incontinence in women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
healthy bladder habits and pelvic floor muscle training in women |
intervention program lasts for 6 weeks with once in a week follow up. which include 8 exercises performed in supine sitting and standing. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1 Age more than 50 years
2 Gender Female
Normal cognitive function MOCA more than and equal to 26
3 QUID scores Stress scores more than and equal to 4 for Stress Urinary Incontinence SUI and Urge scores more than and equal to 6 for Urge Urinary Incontinence (UUI)
|
|
| ExclusionCriteria |
| Details |
1 Any other diagnosed orthopedic neurological Psychiatric condition
2 Previous surgery for urinary incontinence
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Michigan Incontinence symptom index (M-ISI).
• Incontinence quality of life (IQOL)
|
The intervention consists of 6 weeks protocol. first 1-2 weeks focuses the training in supine next 3-4 training in supine and sitting and last 5-6 weeks focusees the training in supine sitting and standing.
outcome measure is administred pre intervention ( baseline) and post intervention ( after 6 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
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)
|
20/07/2025 |
| 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="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
|
This study is prospective interventional single group study aiming to study the effect of healthy bladder habits and pelvic floor muscle training on urinary incontinence in women 50 and above. the intervention program will last for 6 weeks with outcome being assessed at baseline ( i.e. before intervention on day 1) and after intervention( after 6 weeks) · |