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CTRI Number  CTRI/2021/06/034051 [Registered on: 07/06/2021] Trial Registered Prospectively
Last Modified On: 15/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect Of Electrotherapy Or Pelvic Floor Muscle Training On Quality of Life Of Male Geriatric Population With Urinary Incontinence. 
Scientific Title of Study   Impact Of Electrotherapy Or Muscle Training On Quality of Life In Urinary Incontinence Of Male Geriatric Population. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashish Wasudeorao Bele 
Designation  Associate Professor 
Affiliation  Ravi Nair Physiotherapy College, Datta Meghe Institute Of Medical Sciences (DU) 
Address  Department Of Community Health Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute Of Medical Sciences (DU)
Sawangi Meghe
Wardha
MAHARASHTRA
442107
India 
Phone  9960890681  
Fax    
Email  drashishbele@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohd Irshad Qureshi 
Designation  Principal 
Affiliation  Ravi Nair Physiotherapy College Datta Meghe Institute Of Medical Sciences (DU) 
Address  Department of Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute Of Medical Sciences (DU)
Sawangi Meghe
Wardha
MAHARASHTRA
442107
India 
Phone  9406010010  
Fax    
Email  irshadphysio@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mohd Irshad Qureshi 
Designation  Principal 
Affiliation  Ravi Nair Physiotherapy College Datta Meghe Institute Of Medical Sciences (DU) 
Address  Department of Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute Of Medical Sciences (DU)
Sawangi Meghe
Wardha
MAHARASHTRA
442107
India 
Phone  9406010010  
Fax    
Email  irshadphysio@rediffmail.com  
 
Source of Monetary or Material Support  
Ravi Nair Physiotherapy College And Acharya Vinoba Bhave Rural Hospital 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
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 Ashish Wasudeorao Bele  Ravi Nair Physiotherapy College And Acharya Vinoba Bhave Rural Hospital  Department of Community Health Physiotherapy, Sawangi (Meghe)
Wardha
MAHARASHTRA 		 9960890681

drashishbele@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N508||Other specified disorders of malegenital organs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Faradic Stimulation  Frequency: 100 Hz, a biphasic pulse shape with 1-s bursts and 500 ms wide pulse. 
Comparator Agent  Pelvic Floor Muscle Training For Men  1. In standing position 2. In sitting position 3. In lying position 4. While walking 5. After urinating 
Intervention  Russian Current Stimulation  Medium-frequency alternating current. Frequency of 2500 Hz delivered in 50 bursts per second. The burst has duration of 10 milliseconds.  
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Male 
Details  Participants with urinary incontinence and those are willing to participate 
 
ExclusionCriteria 
Details  1. Participants with post-prostatectomy.
2. Females.
3. Age below 60 years.
4. Participants with the history of an uncontrolled hypertension, recent acute Myocardial Infarction, artificial pacemaker, bleeding from the urinary bladder or the digestive tract, urinary tract infection, polyuria, uncontrolled diabetes mellitus, neurologic conditions affecting coordination and balance. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Perineometer
2. International Consultation of Incontinence Questionnaire – Short Form (ICIQ- UI SF)
3.Incontinence Impact Questionnaire – Short Form IIQ-7 		 Day 1 And at the end of two weeks 
 
Secondary Outcome  
Outcome  TimePoints 
3 Incontinence Questionnaire (3IQ).  Day 1 
 
Target Sample Size   Total Sample Size="81"
Sample Size from India="81" 
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)   21/06/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Research Protocol Impact of Electrotherapy or Muscle Training on Quality of Life in Urinary Incontinence of Male Geriatric Population- A Protocol.Journal of Clinical and Diagnostic Research. 2021 Mar, Vol-15(3): YK01-YK03. DOI: 10.7860/JCDR/2021/45595.14597 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Primary purpose of the protocol is to find the impact of Electrotherapy (Faradic stimulation and Russian current stimulation) or training of muscle (Pelvic Floor)  on Quality Of Life in male geriatric population with incontinence of urine.  
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