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CTRI Number  CTRI/2024/02/062585 [Registered on: 13/02/2024] Trial Registered Prospectively
Last Modified On: 07/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized Factorial Trial 
Public Title of Study   The purpose of this study is to find effectiveness of BeBo concept on stress urinary incontinence among the post menopausal women.  
Scientific Title of Study   EFFECTIVENESS OF BeBo CONCEPT ON STRESS URINARY INCONTINENCE AMONG POST-MENOPAUSAL WOMEN. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  VIJAYALAKSHMI G 
Designation  PG STUDENT MPT WOMENS HEALTH 2ND YEAR 
Affiliation  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH. 
Address  FACULTY OF PHYSIOTHERAPY NO.1 SRI RAMACHANDRA NAGAR , PORUR , CHENNAI.
NO.1 SRI RAMACHANDRA NAGAR , PORUR , CHENNAI.
Kancheepuram
TAMIL NADU
600116
India 
Phone  8072940145  
Fax    
Email  vithyaganapathy@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrBSATHYAPRABHA 
Designation  ASSOCIATE PROFESSOR 
Affiliation  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH. 
Address  FACULTY OF PHYSIOTHERAPY NO.1 SRI RAMACHANDRA NAGAR , PORUR , CHENNAI.
NO.1 SRI RAMACHANDRA NAGAR , PORUR , CHENNAI.
Kancheepuram
TAMIL NADU
600116
India 
Phone  9677290892  
Fax    
Email  sathya.b@sriramachandra.edu.in  
 
Details of Contact Person
Public Query  
Name  VIJAYALAKSHMI G 
Designation  PG STUDENT MPT WOMENS HEALTH 2ND YEAR 
Affiliation  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH. 
Address  FACULTY OF PHYSIOTHERAPY NO.1 SRI RAMACHANDRA NAGAR , PORUR , CHENNAI.
FACULTY OF PHYSIOTHERAPY NO.1 SRI RAMACHANDRA NAGAR , PORUR , CHENNAI.
Kancheepuram
TAMIL NADU
600116
India 
Phone  8072940145  
Fax    
Email  vithyaganapathy@gmail.com  
 
Source of Monetary or Material Support  
SRI RAMACHANDRA HOSPITAL. NO.1 SRI RAMACHANDRA NAGAR , PORUR , CHENNAI , TAMILNADU 600116 
 
Primary Sponsor  
Name  NO SPONSOR 
Address  NO SPONSOR 
Type of Sponsor  Other [NO SPONSOR] 
 
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 
DrBSATHYAPRABHA  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH  NO-1 SRI RAMACHANDRA NAGAR PORUR CHENNAI TAMILNADU 600116
Kancheepuram
TAMIL NADU 		 967729089

sathya.b@sriramachandra.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE FOR STUDENTS PROJECTS DHR/ICMR Registration No: ECINEW/INST/2023/TN/0321  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  BeBo concepts  Women from the exercising group participated in a 12-weeks physical therapy program according to the BeBo Pelvic Floor Training Concept. Individual meetings were held thrice a week, each lasting 60 min. Each meeting consisted of a theoretical part lasting up to 10 min and a practical part lasting about 50 min. In addition, each participant received a set of exercises to be performed at home once daily. The homework included the following activities: concentration on the pelvic floor muscles and becoming aware of them in various body positions, mobilization of the pelvis in a sitting position on a chair—10x, lying on the back with bent legs and activation of PFM with exhalation, inhalation—relaxation—10x, balance exercise, standing on one leg, 10 s each leg.in further weeks the repetitions will be lowered with increase in time. 
Comparator Agent  standardized pelvic floor exercises  Standardized pelvic floor exercises: (1) pelvic floor muscle education through per vaginal method. (2) avoid hip adduction, breath holding and pelvic bridging. (3) alternating fast and slow contractions serve as the key elements of the exercises 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1 post-menopausal women with stress urinary incontinence.
2 consented to participate in the study 
 
ExclusionCriteria 
Details  1 Women who had experienced a menopause due to medical conditions such as hysterectomy,
oophorectomy, radiation or chemotherapy
2 Women with mental illness and chronic disease including severe cardiovascular problems,
neurological issues, severe musculoskeletal problems, severe hypertension and diabetes mellitus.
3 Pre menopausal women.
4 Women with incontinence other than stress.
5 Uterine prolapse.
6 severe urinary tract infection or vaginal infection. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Perineometer MMT and QUID Questionnaire  12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 1 
Date of First Enrollment (India)   20/02/2024 
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="5"
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   Post-menopausal women with stress urinary incontinence will be screened in Sri Ramachandra Hospital from obstetrics and gynaecology Outpatient and Inpatient department. Based on the inclusion criteria subjects will be randomly divided into 2 groups. Group A (Control group) and Group B (Experimental group). Group A will receive standardized pelvic floor exercises for the period of 12 weeks (5 days per week). Group B will receive pelvic floor muscle training on BeBo concept for the period of 12 weeks (3 days per week). During pre and post interventions, patients in both Group A and Group B will be assessed for pelvic floor muscle strength by a trained therapist using perineometer, Manual Muscle Testing and stress urinary incontinence symptoms using QUID. 
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