| 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
|
|
|
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
|
|
|
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
|
|
|
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. |