| CTRI Number |
CTRI/2025/08/092705 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| 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
|
The Effect of Brain Stimulation and Pelvic Floor Exercises on Urinary Incontinence in Older Women |
|
Scientific Title of Study
|
Effect of Transcranial Direct Current stimulation combined with pelvic
floor muscle training on urinary incontinence in elderly women- A randomised 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 |
Sanika Aherkar |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Department of Neuro physiotherapy, Dr. D. Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8824856101 |
| Fax |
|
| Email |
aherkarsanika1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Gazbare |
| Designation |
Professor |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Department of Neuro physiotherapy, Dr. D. Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9096116134 |
| Fax |
|
| Email |
preeti.gazbare@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sanika Aherkar |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Department of Neuro physiotherapy, Dr. D. Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8824856101 |
| Fax |
|
| Email |
aherkarsanika1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil College of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Sanika Aherkar |
| Address |
Dr. D. Y. Patil College of Physiotherapy,Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018 |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 Sanika Aherkar |
Dr. D. Y. Patil College of Physiotherapy |
Out Patient Department, Dr. D. Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA |
8824856101
aherkarsanika1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Of Dr. D. Y. Patil College of Physiotherapy, Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R32||Unspecified urinary incontinence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A (tDCS+PFMT PROGRAMME) |
Transcranial Direct Current Stimulation (tDCS):
Device: Use a standard tDCS device with anodal and cathodal electrodes.
Placement: Group A-Anodal electrode over the primary motor cortex (M1) and cathodal electrode over the contralateral supraorbital area.
Parameters: 1.5mA intensity, 20 minutes per session, 3sessions per week for 4 weeks
Group B-Anode-on supplementary motor area and cathodal electrode over the centrally on forehead
centrally on forehead
Duration of tdcs- 20 min
Pelvic Floor Muscle Training (PFMT) Protocol
Week 1–2: Basic PFMT Exercises
Slow Contractions
Description: Contract the pelvic floor muscles for 3 seconds, then relax for 6 seconds.
Repetitions: 5
Sets: 2
Quick Contractions
Description: Rapid contraction and release of the pelvic floor muscles. Each contraction is held for less than 2 seconds.
Repetitions: 5
Sets: 2
Week 3–4: Progression in PFMT
Sustained Hold (Increased Duration)
Description: Contract the pelvic floor muscles for 8–10 seconds, then relax for 3 seconds.
Repetitions: 5
Sets: 2
Assisted Rolling Rotation
Description: Engage the core and pelvic muscles through rolling exercises.
Repetitions: 5
Sets: 2
Assisted Bridging
Description: Engage the core and pelvic muscles through bridging movements.
Repetitions: 5
Sets: 2
|
| Comparator Agent |
Group B (PFMT) |
Pelvic Floor Muscle Training (PFMT) Protocol
Week 1–2: Basic PFMT Exercises
Slow Contractions
Description: Contract the pelvic floor muscles for 3 seconds, then relax for 6 seconds.
Repetitions: 5
Sets: 2
Quick Contractions
Description: Rapid contraction and release of the pelvic floor muscles. Each contraction is held for less than 2 seconds.
Repetitions: 5
Sets: 2
Week 3–4: Progression in PFMT
Sustained Hold (Increased Duration)
Description: Contract the pelvic floor muscles for 8–10 seconds, then relax for 3 seconds.
Repetitions: 5
Sets: 2
Assisted Rolling Rotation
Description: Engage the core and pelvic muscles through rolling exercises.
Repetitions: 5
Sets: 2
Assisted Bridging
Description: Engage the core and pelvic muscles through bridging movements.
Repetitions: 5
Sets: 2
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
1. Age 60 years and above elderly women: Participants should be older adults to target the geriatric population.
2. Diagnosis of urinary incontinence: Participants should have a clinical diagnosis of stress urinary incontinence, urge urinary incontinence, or mixed urinary incontinence.
3. Women who scores more than 2 on Incontinence Severity Index.(ISI) .
4.Participants should be able to understand and perform simple exercises with guidance.
5.Womens who can follow simple commands.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Stop test
International Consultation on Incontinence Questionnaire-Short Form
.Incontinence Impact questionnaire-7(IIQ-7)
1-hour pad test |
Baseline Assessment and Post Intervention assessment after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
19/08/2025 |
| 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="0"
Months="6"
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
|
his randomized controlled trial aims to evaluate the effectiveness of transcranial direct current stimulation (tDCS) combined with pelvic floor muscle training (PFMT) in improving urinary incontinence among elderly women aged above 55 years. The study will be conducted at Dr. D.Y. Patil Hospital and affiliated centers in Pune, India. A total of 60 participants diagnosed with urinary incontinence will be conveniently sampled and randomly assigned to either an experimental group (tDCS + PFMT) or a control group (PFMT alone), with 30 participants in each group.
The PFMT protocol consists of two phases:
-
Weeks 1–2: Basic training with slow contractions (3 sec hold, 6 sec relax) and quick contractions (rapid squeeze-release), 5 repetitions × 2 sets each.
-
Weeks 3–4: Progressed exercises including sustained holds (8–10 sec), assisted rolling rotation, and assisted bridging exercises, each for 5 repetitions × 2 sets.
Outcome measures include the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), 1-hour pad test, Stop test, and Incontinence Impact Questionnaire (IIQ-7). The primary goal is to assess the difference in symptom severity, urinary leakage, pelvic floor strength, and quality of life between the two groups. |