| CTRI Number |
CTRI/2025/09/095381 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
23/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparing two sets of strengthening exercise for the stress incontinence in female patients |
|
Scientific Title of Study
|
Comparative analysis of transverse abdominis strengthening versus hip adductor strengthening along with pelvic floor muscle training in female patients with stress incontinence. 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 |
ANJANA SHRI R V |
| Designation |
PG RESIDENT |
| Affiliation |
SRI RAMAKRISHNA INSTITUTE OF PARAMEDICAL SCIENCES |
| Address |
3RD FLOOR, 2ND ROOM, COLLEGE OF PHYSIOTHERAPY, SRI RAMAKRISHNA INSTITUTE OF PARAMEDICAL SCIENCES, 395, SAROJINI NAIDU ROAD, SIDHAPUR, COIMBATORE
Coimbatore
TAMIL NADU
641044
India |
| Phone |
8678926179 |
| Fax |
|
| Email |
anjanavenkatguptha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SURYA GOPALAKRISHNAN |
| Designation |
MPT (OBSTETRICS AND GYNAECOLOGY)) |
| Affiliation |
SRI RAMAKRISHNA INSTITUTE OF PARAMEDICAL SCIENCES |
| Address |
3RD FLOOR, 2ND ROOM, COLLEGE OF PHYSIOTHERAPY, SRI RAMAKRISHNA INSTITUTE OF PARAMEDICAL SCIENCES, 395, SAROJINI NAIDU ROAD, SIDHAPUR, COIMBATORE
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9496808936 |
| Fax |
|
| Email |
suryagopalakrishnans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SURYA GOPALAKRISHNAN |
| Designation |
MPT (OBSTETRICS AND GYNAECOLOGY)) |
| Affiliation |
SRI RAMAKRISHNA INSTITUTE OF PARAMEDICAL SCIENCES |
| Address |
3RD FLOOR, 2ND ROOM, COLLEGE OF PHYSIOTHERAPY, SRI RAMAKRISHNA INSTITUTE OF PARAMEDICAL SCIENCES, 395, SAROJINI NAIDU ROAD, SIDHAPUR, COIMBATORE
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9496808936 |
| Fax |
|
| Email |
suryagopalakrishnans@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ANJANA SHRI R V |
| Address |
3RD FLOOR, 2ND ROOM, COLLEGE OF PHYSIOTHERAPY, SRI RAMAKRISHNA INSTITUTE OF PARAMEDICAL SCIENCES, 395, SAROJINI NAIDU ROAD, SIDHAPUR, COIMBATORE |
| Type of Sponsor |
Other [SELF ] |
|
|
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 |
| SURYA GOPALAKRISHNAN |
SRI RAMAKRISHNA MULTI SPECIALITY HOSPITAL |
Sri Ramakrishna Multi Specialty hospital, Physiotherapy Department, SAROJINI NAIDU ROAD, SIDHAPUDUR, COIMBATORE
Coimbatore
TAMIL NADU |
9496808936
suryagopalakrishnans@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI RAMAKRISHNA HOSPITAL ETHICAL COMMITTEE |
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, (2) ICD-10 Condition: N393||Stress incontinence (female) (male), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1 TRANSVERSE ABDOMINIS STRENGTHENING ALONG WITH PELVIC FLOOR MUSCLE TRAINING
2 HIP ADDUCTOR STRENGTENING ALONG WITH PELVIC FLOOR MUSCLE TRAINING |
THESE ARE TWO GROUP OF STRENGTHENING EXERCISE AMOUNG WHICH EXERCISE IS COMPARATIVELY BENEFITIAL FOR THE STRESS INCONTINNECE IN FEMALE PATIENTS |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1 MULTIPAROUS WOMEN
2 MENOPAUSE WOMEN
3 NORMAL VAGINAL DELIVERY (INCLUDING EPISIOTOMY, INSTRUMENTAL ASSISTED)
4 WOMEN WHO HAS GRADE I AND II OF STRESS INCONTINENCE (INGELMANN SUNDBERG GRADING)
|
|
| ExclusionCriteria |
| Details |
1 PRIMIPAROUS WOMEN
2 C- SECTION AND OTHER SURGICAL PROCEDURE DURING PREGNANCY UNDERGONE
3 NEUROGENIC BLADDER
4 UNDER ANY MEDICATIONS
5 HYPER AND HYPO THYROIDISM
6 Diabetes mellitus
7 Pulmonary conditions
8 Pelvic organ prolapse and pelvic organ dysfunction |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 20 Minute Pad test |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Kings Health Questionnaire |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
08/10/2026 |
| 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
|
Stress incontinence is a prevalent condition among women often associated with pelvic floor muscle weakness and insufficient core or muscle support. Emerging evidence suggests that the transverse abdominis and hip adductors play a crucial role in enhancing pelvic floor muscle. The need for the study is to give a simple form of exercise to women before going to surgical intervention in the severe stages of pelvic floor weakness. This study is to compare Transverse abdominis strengthening versus Hip adductor strengthening each combined with Pelvic floor muscle training in reducing symptoms of stress incontinence in female patients. A quasi experimental study will be conducted involving female patients diagnosed with stress urinary incontinence. Participants were selected using purposive sampling method and assigned into two groups: Group A: Transverse Abdominis strengthening along with pelvic floor muscle training Group B: Hip Adductor strengthening along with pelvic floor muscle training The intervention will be given during which patients undergo structured exercise protocols under physiotherapy guidance. Outcome measures include the 20-minute pad test to quantify urine leakage and the King’s Health Questionnaire (KHQ) to assess the impact on quality of life. Since the whole study takes a 8 weeks of duration not every women is affordable and can come for daily visit to hospital so I am having this is telerehabilitation with initial and final sessions are taken in hospital. |