| CTRI Number |
CTRI/2024/03/064728 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
21/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Changes in ability to control urine leakage after exercises in women |
|
Scientific Title of Study
|
Changes in strength and endurance of pelvic floor muscles post a Pelvic Floor Muscle Training program using EMG biofeedback in middle-aged women with urinary incontinence in a tertiary care hospital- Pilot 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 |
Ms Kirti Joshi |
| Designation |
Assistant Professor |
| Affiliation |
M S Ramaiah College of Physiotherapy, M S Ramaiah University of applied sciences |
| Address |
Room no 1,Ramaiah College of Physiotherapy, 3rd floor, Academic block, Ramaiah Medical College Hospital,
M S RUAS, New BEL Road,
MSRIT post,
Bangalore
Bangalore KARNATAKA 560054 India |
| Phone |
9686851063 |
| Fax |
|
| Email |
kirtijoshi.rcp@msruas.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Ms Kirti Joshi |
| Designation |
Assistant Professor |
| Affiliation |
M S Ramaiah College of Physiotherapy, M S Ramaiah University of applied sciences |
| Address |
Room no 1,Ramaiah College of Physiotherapy, 3rd floor, Academic block, Ramaiah Medical College Hospital,
M S RUAS, New BEL Road,
MSRIT post,
Bangalore
Bangalore KARNATAKA 560054 India |
| Phone |
9686851063 |
| Fax |
|
| Email |
kirtijoshi.rcp@msruas.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Ms Kirti Joshi |
| Designation |
Assistant Professor |
| Affiliation |
M S Ramaiah College of Physiotherapy, M S Ramaiah University of applied sciences |
| Address |
Room no 1,Ramaiah College of Physiotherapy, 3rd floor, Academic block, Ramaiah Medical College Hospital,
M S RUAS, New BEL Road,
MSRIT post,
Bangalore
Bangalore KARNATAKA 560054 India |
| Phone |
9686851063 |
| Fax |
|
| Email |
kirtijoshi.rcp@msruas.ac.in |
|
|
Source of Monetary or Material Support
|
| Seed Grant from M S Ramaiah University of applied sciences |
|
|
Primary Sponsor
|
| Name |
M S Ramaiah University of Applied Sciences |
| Address |
2nd floor, University building, M S Ramaiah University of Applied Sciences, Gnanagangotri Campus, MSRIT post, Bangalore 560054 |
| Type of Sponsor |
Other [State Private 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 |
| Ms Kirti Joshi |
Ramaiah Memorial Hospital |
Consultation Room no 1, Center for Rehabilitation, Basement, Ramaiah Memorial Hospital,New BEL road, MSRIT post, Bangalore 560054 Bangalore KARNATAKA |
9686851063
kirtijoshi.rcp@msruas.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, M S Ramaiah Medical College and Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N393||Stress incontinence (female) (male), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pelvic floor exercises |
8 sessions spread over 12 weeks under supervision with Biofeedback
home program will be given for daily adherence at home |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Middle aged women in the age group of 40-60 years
2. Symptomatic with urinary incontinence
|
|
| ExclusionCriteria |
| Details |
1. Untreated Urinary Tract Infection
2. Haematuria
3. Grade 3 or 4 pelvic organ prolapse
4. Pelvic surgeries in the past 6 months
5. Uncontrolled diabetes
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Pelvic floor muscle strength 2.Pelvic floor muscle endurance |
1st assessment-Baseline
2nd assessment after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
 Quantitative measures-
1. Attendance rate- Number of sessions attended
2. Adherence rate- Number of days the participants who complete the home exercise program
3. Withdrawal rate- Number of participants who withdraw from the trial divided by the number of participants who consented for the program
 Qualitative measures-
Patient Acceptability will be recorded by interview method
|
at end of 3 months |
|
|
Target Sample Size
|
Total Sample Size="32" Sample Size from India="32"
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)
|
31/03/2024 |
| 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="8" 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
|
The prevalence and causes of incontinence have been reported extensively in the literature. However, there is a dearth of literature on conservative management of incontinence using advanced technology in a tertiary care center from India. It is also important to report the feasibility and acceptability of this intervention as it requires an extended center based follow up period. Evidence suggests that women between the age group of 41-50 years are most likely to experience urinary incontinence and can be managed conservatively. Thus, this pilot study will help in analyzing objectively the effect of a structured pelvic floor muscle training program (PFMT) using EMG biofeedback on improving pelvic floor muscle strength and endurance in middle aged women with incontinence and report their acceptance and adherence to the program in a tertiary care center. Middle aged women with incontinence referred by urologist or gynecologist or direct walk in to physiotherapy will be screened for the program. 32participants who meet the inclusion criteria with consent will be recruited in the study. Participants will undergo a pre and post assessment for symptoms and pelvic floor strength and endurance using a Perineometer. They will undergo a 3 months routine structured PFMT program incorporating patient education, pelvic floor exercise using biofeedback and home exercises. Acceptability and adherence of the program will be recorded. Patient interviews will be conducted to analyze the acceptability of the program and understand any challenges. |