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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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