| CTRI Number |
CTRI/2025/01/079548 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
10/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TENS vs medical management in children with OAB |
|
Scientific Title of Study
|
Comparing the efficacy of para-sacral Trans-cutaneous electrical Nerve Stimulation(TENS) with medical management in the treatment in children with Over-Active Bladder(OAB) - A prospective randomized study. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arunaa Sathyamurthy |
| Designation |
PhD scholar |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher education and research
Department of Pediatric urology
Porur
Chennai
Sri Ramachandra Institute of Higher education and research
Department of Pediatric urology
Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9445971098 |
| Fax |
|
| Email |
arunaa.ms9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Babu |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher education and research
Department of Pediatric urology
Porur
Chennai
Sri Ramachandra Institute of Higher education and research
Department of Pediatric urology
Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9445971098 |
| Fax |
|
| Email |
drrameshbabu1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Babu |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher education and research
Department of Pediatric urology
Porur
Chennai
Sri Ramachandra Institute of Higher education and research
Department of Pediatric urology
Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9840359062 |
| Fax |
|
| Email |
drrameshbabu1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research
Porur
Chennai-116
Tamil Nadu
India |
|
|
Primary Sponsor
|
| Name |
Arunaa Sathyamurthy |
| Address |
Sri Ramachandra Institute of Higher Education and Research
Porur
Chennai- 600116
Tamil Nadu
India |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Ramesh Babu |
Sri Ramachandra Institute of Higher education and research |
Sri Ramachandra Institute of Higher education and research
Department of Pediatric Urology
Porur
Chennai
Chennai
TAMIL NADU |
9840359062
drrameshbabu1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee -Sri Ramachandra Institute of Higher education and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N318||Other neuromuscular dysfunction ofbladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Medical management |
Duration will be 1 month (once daily for 4 weeks) |
| Comparator Agent |
NA |
NA |
| Intervention |
Para-sacral Trancutaneous electrical nerve stimulation |
Duration of the treatment will be 1 month (20 mins daily for 4 weeks) |
| Intervention |
Transcutaneous Electrical Nerve Stimulation |
Patient will undergo TENS-a nerve stimulation (no pain, discomfort and no risk) for overactive bladder condition ) which is devoid of side effects when compared to gold standard medical management for overactive bladder |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
•Age 5-18 years
•Lower urinary tract symptoms of recent onset
•Bowel symptoms evaluated and treated
|
|
| ExclusionCriteria |
| Details |
•Neurological abnormality (X- ray Spine)
•Obstructive uropathy (Ultrasound of Kidney Ureter Bladder)
•Active Urinary Tract Infection(Urine routine (culture if needed)
•Uncontrolled bowel bladder dysfunction (X-ray abdomen/Ultrasound)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To show significant improvement in symptoms post administration of Trancutaneous electrical Nerve Stimulation |
This will be assessed after 4 weeks of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To provide that Trans-cutaneous Nerve Stimulation is devoid of side effects & provide a standard follow up period |
It will be assessed after 3 months & 6 months post treatment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
17/02/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
Systematic review and meta analysis on the role of Transcutaneous electrical Nerve Stimulation in children with overavctive bladder - A pooled analysis of nine randomized controlled trials |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Overactive bladder encompasses a wide range of conditions in children which present with incontinence. Overactive bladder in children often causes urgency, frequency, incontinence and daytime wetting leading to low self-esteem & depression in school going children. Over active bladder (OAB) is a symptom complex consisting of urgency, with or without urge incontinence, usually with frequency and nocturia. The prevalence of overactive bladder is 5–12% in children and 0.5% in adolescents with a slight male preponderance. It is possible that TENS is more effective than current medical management in overactive bladder as children could be more compliant, due to the ease of the procedure and lack of side effects. In future TENS may also become useful in other groups of secondary bladder dysfunction – like valve bladders, neurogenic bladders etc. |