| CTRI Number |
CTRI/2025/07/091538 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Exercise for incontinence in women. |
|
Scientific Title of Study
|
Effectiveness of Ultrasound-guided Pelvic-floor exercise on incontinence severity, Post-void residual volume and Frequency of urinary tract infection for Women with Stress urinary incontinence. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nupur Akter |
| Designation |
MPT in Gynecology and Womens Health (Fellow) |
| Affiliation |
Jashore University of Science and Technology (JUST) |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore
7408
Other |
| Phone |
8801403460594 |
| Fax |
|
| Email |
nupurakter1522@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharmila Jahan |
| Designation |
Assistant Professor |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore
7408
Other |
| Phone |
8801717362485 |
| Fax |
|
| Email |
sh.jahan@just.edu.bd |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharmila Jahan |
| Designation |
Assistant Professor |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore
7408
Other |
| Phone |
8801717362485 |
| Fax |
|
| Email |
sh.jahan@just.edu.bd |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
(JUST), Jashore-7408, Bangladesh |
|
|
Primary Sponsor
|
| Name |
Nupur Akter |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University
of Science and Technology (JUST), Jashore-7408, Bangladesh. |
| Type of Sponsor |
Other [Self-funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Md Kabir Hossain |
Dr. M R Khan Medical Center, Jashore University of Science and Technology, Jashore-7408, Bangladesh. |
Room no: 306, 2nd
floor, Department of
Physiotherapy and
Rehabilitation, Jashore
University of Science
and Technology,
Jashore-7408,
Bangladesh.
|
01778315139
mkb.hossain@just.edu.bd |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board of Department of Physiotherapy and Rehabilitation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1 |
The experimental group will receive ultrasound-guided Kegel exercises in the lying position, following the registered protocol for prescribing pelvic floor exercises (PFE) in women with stress urinary incontinence (SUI). A curvilinear probe will be placed on the lower abdomen to visualize the urinary bladder, allowing the patient to perform the exercises with real-time ultrasound guidance, which will serve as a biofeedback mechanism. The treatment will be administered twice a week, with each session lasting 45 minutes, over a total duration of 8 weeks. Each session will include three steps: (1) activation of the transversus abdominis muscle for 15 minutes, with 5 repetitions involving a 5-second hold and 2-second rest; (2) external oblique activation for another 15 minutes with the same repetition and timing; and (3) internal oblique activation, also for 15 minutes with identical repetition and rest intervals. |
| Comparator Agent |
Group 2 |
The control group will receive conventional Kegel exercises in the lying position, following the registered protocol for prescribing pelvic floor exercises (PFE) for women with stress urinary incontinence (SUI). The intervention will be delivered twice a week, with each session lasting 45 minutes, over a total period of 8 weeks. Each session will consist of three structured steps targeting specific core muscles: (1) transversus abdominis strengthening through Abdominal Drawing-In Maneuver and Dead Bug exercises for 15 minutes, with 10 repetitions involving a 5-second hold and a 2-second rest; (2) external oblique strengthening using Side Plank and Bicycle Crunch exercises, also for 15 minutes with the same repetition and rest pattern; and (3) internal oblique strengthening through Bridge Pose and Reverse Crunch exercises, conducted for another 15 minutes with identical repetition and rest intervals. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Parous (Given birth to 1 child).
2. Nulliparous (Never given birth).
3. Diagnosed as Urinary Tract Infection and Stress Urinary Incontinence.
4. BMI of 18–30 kg/m2 |
|
| ExclusionCriteria |
| Details |
1. Pregnant or gave birth in the past six months.
2. History of pelvic surgery.
3. Chronic respiratory diseases.
4. Diabetes.
5. Use of medications for Urinary Tract Infection.
6. Cardiac pacemaker implanted.
7. Psychological disorders. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incontinence severity |
2 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Frequency of urinary tract infection |
2 Months |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="0"
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 2 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/08/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
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
|
An eight-week randomized clinical trial will evaluate the effectiveness of ultrasound-guided pelvic-floor exercise (PFE) in women with stress urinary incontinence (SUI). A total of 220 women aged 18–65 years (110 per group) will be recruited. Participants will be randomly assigned to either an ultrasound-guided PFE group or a control group performing the same exercises without ultrasound guidance. Both groups will attend two 45-minute sessions per week for eight weeks. The primary outcomes are urine leakage (measured by a 1-hour pad test) and post-void residual (PVR) volume assessed via ultrasound. Secondary outcomes include urinary tract infection (UTI) indicators such as pus cells and other urinary components. Women with pregnancy, recent postpartum status, pelvic surgery history, or other medical exclusions will not be included. The trial aims to determine if real-time ultrasound biofeedback improves exercise effectiveness in managing SUI symptoms. |