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CTRI Number  CTRI/2020/12/029496 [Registered on: 02/12/2020] Trial Registered Prospectively
Last Modified On: 01/12/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Evaluation of Bladder functions in Children 
Scientific Title of Study   Assessment of Bladder functions in children with Enuresis 
Trial Acronym  SEMG 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Padmaja Guruprasad 
Designation  Post graduate student 
Affiliation  Dr. D. Y. Patil College of physiotherapy, Pimpri, Pune 
Address  Plot no.84, Sr.no.81/1/1, behind Shrushti hotel, next to Pravin hardware, Pimpale Gurav, Pune
Department of neuropediatric physical therapy,2nd cabin, 3rd floor, Dr. D. Y. Patil College of physiotherapy, Sant tukaram nagar, Pimpri, Pune
Pune
MAHARASHTRA
411061
India 
Phone  07620952111  
Fax    
Email  padmajag1997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vidhi Shah 
Designation  Assistant professor 
Affiliation  Dr. D. Y. Patil College of physiotherapy, Pimpri, Pune 
Address  B-304,Rajshree Sunandha Society,Park Royal Road,Shivrajnagar4, Kokane chowk, Rajarani,Pune
Department of neuropediatric physical therapy,2nd cabin, 3rd floor, Dr. D. Y. Patil College of physiotherapy, Sant tukaram nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India 
Phone  8149385218  
Fax    
Email  vidhivarun13@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Padmaja Guruprasad 
Designation  Post graduate student 
Affiliation  Dr. D. Y. Patil College of physiotherapy, Pimpri, Pune 
Address  Plot no.84, Sr.no.81/1/1, behind Shrushti hotel, next to Pravin hardware, Pimpale Gurav, Pune
Department of neuropediatric physical therapy,2nd cabin, 3rd floor, Dr. D. Y. Patil College of physiotherapy, Sant tukaram nagar, Pimpri, Pune

MAHARASHTRA
411061
India 
Phone  07620952111  
Fax    
Email  padmajag1997@gmail.com  
 
Source of Monetary or Material Support  
Dr.D.Y.Patil college of physiotherapy, Sant Tukaram Nagar, Pimpri , Pune 
 
Primary Sponsor  
Name  Padmaja Guruprasad 
Address  Plot no. 84, sr. No. 81/1/1, Behind hotel SHRUSHTI next to Pravin hardware, pimpale Gurav pune 411061 
Type of Sponsor  Other [Self] 
 
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 
Padmaja Guruprasad  Dr. D. Y. Patil College of physiotherapy Pimpri Pune  Department of neuropediatric physical therapy, 2nd cabin, 3rd floor, Dr. D. Y. Patil College of physiotherapy, Sant tukaram nagar Pimpri Pune
Pune
MAHARASHTRA 
7620952111

padmajag1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. D. Y. Patil Vidyapeeth  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F980||Enuresis not due to a substance orknown physiological condition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  history of bed wetting for atleast 2 times a week
duration of bedwetting for atleast 3 consecutive months.
children with enuresis. 
 
ExclusionCriteria 
Details  Children with Global developmental delay, children with conditions Related to CNS,
Children with mental retardation, children, children with any skin conditions such as blisters , rashes, eczema., Children with operated metal implants. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Surface Electromyography  1st day 
 
Secondary Outcome  
Outcome  TimePoints 
none  none 
 
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   N/A 
Date of First Enrollment (India)   03/12/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Various studies have shown that the incidence of Enuresis is growing the populations. According to a recent study The worldwide prevalence of enuresis among children aged 6–12 years is 1.4%–28%. The prevalence in India is 7.61%–16.3%. The prevalence is highest in children aged 5–8 years (and 6–8 years) and lowest in children aged 11–12 years. In children it has a negative impact socially and psychologically. Detrusor over activity and bladder capacity is one of the contributing factors for enuresis. It impacts the emotional state, self esteem, as well as the social development of a child. Children with nocturnal enuresis have lower self esteem, mental health, skills, and poorer relation to their parents and others. Surface Electromyography at perianal region can be used as an assessment tool in enuresis.

METHODOLOGY

History and consent will be taken from the child’s parent/guardian.

All aseptic precautions will be taken for the outcome measure. The parent or the gaurdian will be present with the child at the time of the assessment.

The bladder function will be assessed using surface EMG: explain the procedure to the child and the gaurdian accompanying the child. Place the surface electrode in the perianal region. Ask the child to squeeze a pillow that is placed between his/ her knees.

The readings will be noted at rest and on maximum contraction and then analyzed.

 
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