| CTRI Number |
CTRI/2026/03/105519 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Improving bladder control in women through jaw massage and pelvic floor exercises |
|
Scientific Title of Study
|
Effect of temporomandibular joint soft tissue manipulation and pelvic floor rehabilitation in women with stress incontinence: A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manisha Pandey |
| Designation |
Post graduate student |
| Affiliation |
Gurugram University gurugram, haryana |
| Address |
Department of Physiotherapy, Gurugram University, Sector 87, Kankrola Village, Gurugram, Gurgaon, Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
7667101884 |
| Fax |
|
| Email |
manishapandey1412@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gurpreet Singh |
| Designation |
Assistant professor |
| Affiliation |
Gurugram university Gurugram, Haryana |
| Address |
Department of Physiotherapy, Gurugram University, Sector 87, Kankrola Village, Gurugram, Gurgaon, Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
9350567096 |
| Fax |
|
| Email |
physio11r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manisha Pandey |
| Designation |
Post graduate student |
| Affiliation |
Gurugram University, gurugram, haryana |
| Address |
Department of Physiotherapy, Gurugram University, Sector 87, Kankrola Village, Gurugram, Gurgaon, Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
7667101884 |
| Fax |
|
| Email |
manishapandey1412@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy,Gurugram University, Kankrola Village,Sector 87, Gurugram, Haryana-122505 |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy |
| Address |
Department of Physiotherapy, Gurugram University, Sector 87, Kankrola Village, Gurugram, Gurgaon, Haryana 122505 |
| Type of Sponsor |
Other [State Government University] |
|
|
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 Manisha Pandey PT |
Department of Physiotherapy,Gurugram University |
Department of Physiotherapy, Gurugram University, Sector 87, Kankrola Village, Gurugram, Gurgaon, Haryana 122505
Gurgaon
HARYANA |
7667101884
manishapandey1412@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94-O9A||Other obstetric conditions, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pelvic floor rehabilitation |
The participants will receive pelvic floor rehabilitation. this includes pelvc floor strengthening exercises, back isometrics, pelvic bridging, SLRs, pelvic contractions, bird-dog, and squats |
| Intervention |
TMJ Soft tissue manipulation and pelvic floor rehabilitation |
Participants in this will receive TMJ soft tissue manipulation massage and pelvic floor rehabilitation. This will include Back isometrics, Kegels exercises, bird-dog pose and squats.
Soft tissue manipulation includes temporalis, masseter, and pterygoid muscle relaxations |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women age between 25-45 years
Women with at least one childbirth past more than 6 months(vaginal delivery)
Women with stress incontinence for more than six month
Women who can read and understand English
IQIC scoring more than 5
|
|
| ExclusionCriteria |
| Details |
Women with any systemic illness
Women with any recent surgery in 6 months
Women ongoing steroid therapy
Women with any mental and neurological conditions that affect the participation in the study
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. stress incontinence
2. quality of life |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
17/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
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 compares the effect of TMJ soft tissue manipulation and pelvic floor rehabilitation with pelvic floor rehabilitation alone on stress incontinence and quality of life in women. Stress incontinence is one of the major factors affecting quality of life in women. A total of 46 women aged between 25-45v years meeting the inclusion criteria will be randomly allocated into two groups. The outcome measures include stress incontinence that will be measured using international consultation on incontinence questionnaire. Quality of life will be measured by incontinence quality of life questionnaire. This study intends to evaluate whether an inter=grated musculoskeletal rehabilitation approach provides superior clinical compared to conventional pelvic floor rehabilitation. |