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CTRI Number  CTRI/2024/04/066087 [Registered on: 22/04/2024] Trial Registered Prospectively
Last Modified On: 20/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Screening
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Pelvic floor muscle exercise for stress urinary incontinence  
Scientific Title of Study   A randomized controlled trial of periodically supervised pelvic floor muscle training versus unsupervised pelvic floor muscle training in comprehensive management of 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  Dr Arulmozhi P 
Designation  Postgraduate 
Affiliation  Sri Manakula Vinayagar Medical College and Hospital 
Address  Department of Obstetrics and Gynecology,OPD room No 68, Sri Manakula Vinayagar Medical College and Hospital, Madhagadipet, Kalitheerthalkuppam,

Pondicherry
PONDICHERRY
605107
India 
Phone  8056453546  
Fax    
Email  arulsweety19@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jayasree  
Designation  Professor 
Affiliation  Sri Manakula Vinayagar Medical College and Hospital  
Address  Department of Obstetrics and Gynecology, OPD room no 68, Infertility, HOD room, Sri Manakula Vinayagar Medical College and Hospital, Madhagadipet, Kalitheerthalkuppam,

Pondicherry

605107
Other 
Phone  9443769196  
Fax    
Email  obg.jayasreem@smvmch.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Arulmozhi P 
Designation  Postgraduate 
Affiliation  Sri Manakula Vinayagar Medical College and Hospital 
Address  Department of Obstetrics and Gynecology,OPD room No 68, Sri Manakula Vinayagar Medical College and Hospital, Madhagadipet, Kalitheerthalkuppam,

Pondicherry
PONDICHERRY
605107
India 
Phone  8056453546  
Fax    
Email  arulsweety19@gmail.com  
 
Source of Monetary or Material Support  
Sri Manakula Vinayagar Medical College and Hospital , Madhagadipet, Kalitheerthalkuppam, Pondicherry 605107 
 
Primary Sponsor  
Name  Sri Manakula Vinayagar Medical College and Hospital 
Address  Madhagadipet, Kalitheerthalkuppam, Pondicherry-605107  
Type of Sponsor  Private medical college 
 
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 
Dr Arulmozhi P  Sri Manakula Vinayagar Medical College and Hospital  Department of Obstetrics and Gynecology, OPD Room Number 68, Sri Manakula Vinayagar Medical College and Hospital, Madagadipet, Kalitheerthalkuppam, Pondicherry
Pondicherry
PONDICHERRY 		 8056453546

arulsweety19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMVMCH - ETHICS COMMITTEE  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  Supervised Group - Pelvic floor muscle training with perineometer biofeedback   Supervised Group The Participants whose BMI more than 25 will be prescribed calculated balanced calorie restricted diet with a goal of providing no more than 30% of the calories from fat. sample meal plans will be provided. The Participants are encouraged to gradually increase physical activity (brisk walking or activities of similar intensity) until they were active for at least 200 minutes each week. Participants undergoing pelvic floor muscle training combined with perineometer biofeedback supervised. Patient advised to do pelvic floor muscle exercise with biofeedback training by physiotherapist, and the visual feedback will be projected to the participants and participants are advised to continue pelvic floor muscle exercise at home also. At 0 week Pelvic floor muscle training with perineometer biofeedback by physiotherapist 0- 4 weeks to continue Pelvic floor muscle training at home follow up At 4th week Pelvic floor muscle training with perineometer biofeedback by physiotherapist 4-8 weeks to continue Pelvic floor muscle training at home follow up At 8th week Pelvic floor muscle training with perineometer biofeedback by physiotherapist 8-12 weeks to continue pelvic floor muscle training at home At 12th week Pelvic floor muscle training with perineometer biofeedback by physiotherapist  
Comparator Agent  Unsupervised group - Pelvic floor muscle training at home   The participants whose BMI more than 25 will be prescribed calculated balanced calorie restricted diet with a goal of providing no more than 30% of the calories from fat. Sample meal plans will be provided. The participants will be encouraged to gradually increase physical activity (brisk walking or activities of similar intensity) until they were active for at least 200 minutes each week. Participants undergoing pelvic floor muscle training unsupervised. They will be provided with the pamphlets containing the steps of pelvic floor muscle training. At 0 week Pelvic floor muscle training exercise taught by Prinicpal Investigator 0-4 weeks continue exercise at home At 4th week reminder call to motivate 4-8 weeks continue exercise at home At 8th week reminder call to motivate 8-12 weeks continue exercise at home At 12th week reminder call to motivate  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  Female more than 18 years, whose stress score is more than 4 based on Questionnaire on urinary incontinence Diagnosis (QUID)
able to contract the pelvic floor muscle
 
 
ExclusionCriteria 
Details  2nd and 3rd degree UV prolapse
Presence of Recurrent UTI
urge urinary incontinence
Pregnant women
Chronic Respiratory Disorders
Constipation
Central or peripheral neuropathies
Smoking
H/o previous surgeries of SUI
H/o previous pelvic surgery
Presence of other voiding symptoms
Patient on Diuretics
Patient on drugs which are influencing the function of bladder and urethra.
Palpable pelvic pathology
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the effectiveness of periodically supervised pelvic floor muscle training with unsupervised pelvic floor muscle training in comprehensive management of stress urinary incontinence.

 		 In both the groups
at 0 week - pelvic floor muscle strength that is contraction pressure is checked using perineometer
at 12th week - pelvic floor muscle strength that is contraction pressure is again rechecked and compared between both the groups 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the improvement in pelvic floor muscle strength & quality of life between both groups
 		 In both groups
at 0 week baseline- pelvic floor muscle strength checked; by using questionnaire ISI, ICIQ UI SF severity is assessed.
at 12th week of assessment - pelvic floor muscle strength checked; by using questionnaire ISI, ICIQ UI SF severity is reassessed.  
 
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   Phase 4 
Date of First Enrollment (India)   01/05/2024 
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="1"
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) is defined as an involuntary loss of urine occurring  as a result of raised intra abdominal pressure due to an exertion or on sneezing or coughing. The prevalence of stress urinary incontinence in the female population ranges from 10-40%. It is a long way to make the patients and society to get aware of stress urinary incontinence and it should be treated. Stress urinary incontinence has significant impact on women’s mental health, which leads to depression, anxiety, poor quality of life, low self-esteem, issues related to relationships which affects sexual life and reduced workplace productivity. Pelvic floor muscle training is the first line management of uncomplicated stress urinary incontinence. Performing pelvic floor muscle training with adequate training and frequency is an important factor for better outcome. About 30% of women cannot correctly identify the muscle to be contracted. Hence if biofeedback with perineometer could significantly decrease urine leakage and if improves the pelvic floor muscle strength, Pelvic floor muscle training with biofeedback may become first line of management.

 
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