| CTRI Number |
CTRI/2026/01/102598 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of behavioral therapy in the treatment of Stress Urinary Incontinence |
|
Scientific Title of Study
|
The Efficacy Of Behavioral Therapy In The Treatment Of Stress Urinary Incontinence In Middle Aged Women |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Roshini R |
| Designation |
Postgraduate Student |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
No.1 Ramachandran nagar, Sri Ramachandra Faculty of Physiotherapy, SRIHER, Chennai Tamilnadu
Chennai
TAMIL NADU
600116
India |
| Phone |
9940563671 |
| Fax |
|
| Email |
roshiniphysio0701@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Sathyaprabha |
| Designation |
Professor, HoD, Department of Womens Health |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
No.1 Ramachandran nagar, Sri Ramachandra Faculty of Physiotherapy, SRIHER, Chennai Tamilnadu
Chennai
TAMIL NADU
600116
India |
| Phone |
9677290892 |
| Fax |
|
| Email |
sathya.b@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr B Sathyaprabha |
| Designation |
Professor, HoD, Department of Womens Health |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
No.1 Ramachandran nagar, Sri Ramachandra Faculty of Physiotherapy, SRIHER, Chennai Tamilnadu
No.1 Ramachandran nagar, Sri Ramachandra Faculty of Physiotherapy, SRIHER, Chennai Tamilnadu
Chennai
TAMIL NADU
600116
India |
| Phone |
9677290892 |
| Fax |
|
| Email |
sathya.b@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
RoshiniR |
| Address |
No.1 Sri Ramachandra nagar, Sri Ramachandra faculty of physiotherapy, SRIHER,porur, chennai, Tamilnadu |
| Type of Sponsor |
Private 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 |
| RoshiniR |
Department of Urology, Department of Obstetrics and Gynaecology. |
No.1 Ramachandran nagar, Sri Ramachandra Hospital, SRIHER, Chennai Tamilnadu
Chennai
TAMIL NADU |
9940563671
roshiniphysio0701@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Stress urinary incontinence |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Abdominal strengthening exercises, Behavioral Training and Kegels exercise |
Abdominal strengthening exercises , Behavioral Training and Kegels exercise with progression for 5 days a week for 8 weeks. |
| Comparator Agent |
Kegels exercise, abdominal strengthening exercises |
Kegels exercise, abdominal strengthening exercises |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Female |
| Details |
Women between the aged 45–59 years of age.
Clinically diagnosed with stress urinary incontinence
Not currently engaged in any pelvic floor rehabilitation program.
Women who give willingness to participate in the study.
Able to understand and follow verbal commands or instructions. |
|
| ExclusionCriteria |
| Details |
Mixed or urge urinary incontinence
Pregnancy or postpartum (within 6 months).
Women with severe cardiovascular problems, neurological issues, severe musculoskeletal problems
Neurological conditions affecting bladder control (e.g., multiple sclerosis, spinal cord injury).
Those with pelvic organ malignancy, undergoing radical surgery for pelvis, sling or prolapse surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ICIQ-UI SF score reduction and Pelvic floor muscle strength (PERFECT) |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Qol Adherence Subjective improvement & group comparisons |
6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
10/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/02/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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 urinary incontinence (SUI) which is involuntary urine loss or leakage during exercise, getting up from lying down, coughing or sneezing. Stress urinary incontinence is considered to be the most common type of incontinence in middle-aged women. Women undergo anatomical and neuromuscular changes and injury during childbirth, which decreases pelvic floor muscle (PFM) strength. The resulting loss of muscular strength combined with the lack of tissue resilience prohibits support of the bladder neck during physical stress and results in leakage. Some women might not experience incontinence until a small loss of pelvic floor muscle strength occurs within the normal aging process – particularly after menopause, through other injuries, or through some medications that might induce incontinence. The majority of exercise protocols targeted pelvic floor muscle properties and integration of exercises into activities of daily living. Most of the patients do not effectively recruit their pelvic floor muscles while performing Kegels and require a therapist supervision. Sung Tae Chol et.al. (2021) stated that PFMT (Kegels) was the most effective when performed under the supervision of a therapist with a biofeedback device to improve PFM strength in adult women with SUI . Alime Buyuk1 et.al. (2021) observed that Pelvic floor muscle training (PFMT) and Behavioral training ( BT) reduced the symptom severity of pelvic floor dysfunction in elderly subjects.
Behavioral Training (BT) actively engage the patient for changing habits or learning new skills. These interventions had to address low risk , affordable and accessible lifestyle and behavioral intervention can used to treat urinary incontinence. It consists of techniques that aim to reduce or even eliminate incontinence symptoms, through education about the condition, changes in lifestyle and bladder training. It involves the patient’s perception of their own body and health conditions, requiring adjustments related to habits and behaviors. The changes include weight loss, avoiding some foods or beverages that are harmful to the bladder, regulation of intestinal function, drinking water correctly, and also a scheduled voiding regimen can reduce urinary symptoms. This study aims to evaluate the effects of Behavioral Training (BT) on severity of stress urinary incontinence symptoms and Pelvic floor muscle strength among middle aged women. |