| CTRI Number |
CTRI/2026/01/102252 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Physiotherapy treatment for urinary incontinence |
|
Scientific Title of Study
|
Designing and testing of a novel wearable device for pelvic floor muscle strength in females with stress urinary incontinence: An Exploratory 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 |
ASHIKA TANNA |
| Designation |
PhD Scholar |
| Affiliation |
ASSISTANT PROFESSOR, MARWADI UNIVERSITY |
| Address |
THE SPACE, MADHAPAR CHOWK, RAJKOT
PHYSIOTHERAPY OPD, FACULTY OF PHYSIOTHERAPY, MARWADI UNIVERSITY, RAJKOT-MORBI HIGHWAY, RAJKOT
Rajkot
GUJARAT
360003
India |
| Phone |
9913694912 |
| Fax |
|
| Email |
ashika.tanna131113@marwadiuniversity.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Kakkad |
| Designation |
Guide and Professor |
| Affiliation |
Professor, Faculty of Physiotherapy, Marwadi University |
| Address |
MB550, Faculty of Physiotherapy, Marwadi University
Main Building, Faculty of Physiotherapy, Marwadi University
Rajkot
GUJARAT
360003
India |
| Phone |
9913694912 |
| Fax |
|
| Email |
ashish.kakkad@marwadiuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Ashika Tanna |
| Designation |
PhD Scholar |
| Affiliation |
Marwadi University |
| Address |
MB 555, Faculty of Physiotherapy, Marwadi University
Faculty of Physiotherapy, Marwadi University
Rajkot
GUJARAT
360003
India |
| Phone |
9913694912 |
| Fax |
|
| Email |
ashika.tanna131113@marwadiuniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Physiotherapy Department, Marwadi University |
|
|
Primary Sponsor
|
| Name |
Shaily grant Incubation center of SIGMA University |
| Address |
Post Bakrol Ajwa Nimeta Road Waghodiya Vadodara Gujarat |
| Type of Sponsor |
Other [Academic Institute] |
|
|
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 ASHIKA TANNA |
Physiotherapy OPD |
Marwadi Physiotherapy Center, "PARAG", Street No 5, Jagnath, Rajkot
Rajkot
GUJARAT |
9913694912
ashika.tanna131113@marwadiuniversity.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MARWADI UNIVERSITY ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N319||Neuromuscular dysfunction of bladder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Kegels Exercise |
Subjects will be performing Kegels exercise under the supervision of a therapist for 4 weeks |
| Intervention |
Russian current stimulation |
Subjects will be receiving treatment by a wearable device (Russian current stimulation) and conventional treatment (Kegels exercise) for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
Women aged between 18-75 years
Women who report at least three episodes of involuntary urine leakage weekly during the past 3 months
Women having Mini-Mental Status Examination (MMSE) score EQUAL OR MORE THAN 24 |
|
| ExclusionCriteria |
| Details |
Body mass index more than or equal to 35 kg/m2
Pelvic Organ Prolapse Quantification System (POP-Q) more than Stage 2
History of pelvic surgery or physiotherapy
Use of medication for UI or affects skeletal muscle function
History of electromagnetic stimulation therapy for Urinary Incontinence
Active urinary tract infection
An implanted cardiac device or cardiac conditions
Neurological diseases
Pregnancy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pelvic floor muscle strength by Digital perineometer |
Pre and post physiotherapy intervention at day 0 and 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Gujarati version of the International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form (ICIQ UI - SF) score and
Gujarati version of the WHOQOL–BREF scale |
Pre and post physiotherapy intervention at day 0 and 4th week |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
16/02/2026 |
| 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 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 an involuntary leakage of urine, which may affect quality of life. Its prevalence is higher after normal delivery and during perimenopause because of pelvic floor muscle weakness. Study involves 44 samples, which will be divided into two groups by lottery method. Group A will receive russian current stimulation with kegels exercise for 4 weeks and group B will receive kegels exercise for 4 week. Primary Outcome measure Pelvic floor muscle strength by perineometer and secondary outcome measure will be taken by Gujarati version of the International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form (ICIQ UI - SF) score ans Gujarati version of the WHOQOL–BREF scale at 0 day and after completion of 4 weeks. Statistical analysis will be done. |