| CTRI Number |
CTRI/2024/11/077471 [Registered on: 28/11/2024] Trial Registered Prospectively |
| Last Modified On: |
29/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Neuromodulation by nerve stimulation] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of electrical pulses in reducing urinary leaks in patients with spinal cord injury |
|
Scientific Title of Study
|
Posterior tibial nerve Vs Sham transcutaneous tibial nerve stimulation as neuromodulation therapy in treatment of detrusor overactivity in patients with spinal cord injury: A randomized control study |
| Trial Acronym |
Restore Continence - RCT1 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Joy Darshan Gurindapalli |
| Designation |
Junior Resident |
| Affiliation |
Department of Physical Medicine and Rehabilitation Christian Medical College |
| Address |
Department of Physical Medicine and Rehabilitation
Christian Medical College, Vellore – 4
Vellore
TAMIL NADU
632002
India |
| Phone |
04162283020 |
| Fax |
|
| Email |
fedjoyshan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajdeep Ojha |
| Designation |
Associate Professor |
| Affiliation |
Department of Physical Medicine and Rehabilitation Christian Medical College |
| Address |
Department of Physical Medicine and Rehabilitation
Christian Medical College, Vellore
Vellore
TAMIL NADU
632002
India |
| Phone |
04162205274 |
| Fax |
|
| Email |
rajdeep@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jacob George |
| Designation |
Senior Professor |
| Affiliation |
Department of Physical Medicine and Rehabilitation Christian Medical College |
| Address |
Department of Physical Medicine and Rehabilitation
Christian Medical College, Vellore – 4
Vellore
TAMIL NADU
632002
India |
| Phone |
04162205274 |
| Fax |
|
| Email |
jacobg@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| TIDE Division, Department of Science and Technology, Govt. of India, Technology Bhavan, New Mehrauli Road, New Delhi, India-110016 |
|
|
Primary Sponsor
|
| Name |
TIDE Division Department of Science and Technology |
| Address |
TIDE Division, Department of Science and Technology, Govt. of India, Technology Bhavan, New Mehrauli Road, New Delhi, India-110016 |
| Type of Sponsor |
Government funding agency |
|
|
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 Joy Darshan Gurindapalli |
Christian Medical College Vellore |
Rehabilitation Institute,
Bagayam,
Christian Medical College Vellore
Vellore
TAMIL NADU |
9834519128
fedjoyshan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Christian Medical College Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, (2) ICD-10 Condition: S342||Injury of nerve root of lumbar andsacral spine, (3) ICD-10 Condition: S242||Injury of nerve root of thoracic spine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
POSTERIOR TIBIAL NERVE STIMULATION |
surface electric transcutaneous posterior nerve stimulation for 30 mins twice daily for 14 consecutive days |
| Comparator Agent |
SHAM STIMULATION |
SHAM transcutaneous tibial nerve stimulation for 30 minutes per session twice daily for 14 consecutive days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
-age 18 years and above
-Patient with spinal cord injury trojan having at least one leak per day(not stress leak) as reported in the voiding chart.
-Clean intermittent catheterization
-Presence of ankle jerk
-CMG proven Detrusor overactivity
|
|
| ExclusionCriteria |
| Details |
-Urinary Tract Infection
-Peripheral Neuropathy
-Pregnant Women
-Psychiatric ailment
-Symptoms of stress incontinence
-Presence of implantable devices such as cochlear implant, pace makers, metallic implantable plates. |
|
|
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 |
1. Reduction in number of leaks as observed by voiding diary
2. Increase in fluid intake as observed by voiding diary
3. Improvement in bladder capacity as observed by the voiding diary |
Outcome 1,2 and 3 are to be monitored one week prior to the start of the stimulation and during the period of stimulation i.e. for 3 weeks everyday. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Reduction of maximum detrusor pressure as observed through Cystometrogram (CMG)
2. Improvement in cystometric capacity as observed by CMG |
Above secondary outcomes will be assessed on Day 1 and Day 15 i.e. Pre and Post Intervention |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 2 |
|
Date of First Enrollment (India)
|
09/12/2024 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Previously two studies were conducted in regard to the neuromodulation of urinary bladder reflex pathway and our findings have been published as below. Both the studies have reported that the use of electrical stimulator on tibial nerve, dorsal penile and medial plantar nerve have reduced the episodes of urinary incontinence as measured by voiding diary in patients with spinal cord injury. Pre and Post Urodynamics studies on these participants have shown reduction in the detrusor overactivity. This study is RCT to study the effect of electrical stimulation in these group of participants on the posterior tibial nerve. 1. Ojha R, George J, Chandy BR, Tharion G, Devasahayam SR. Neuromodulation by surface electrical stimulation of peripheral nerves for reduction of detrusor overactivity in patients with spinal cord injury: A pilot study. J Spinal Cord Med. 2015 Mar;38(2):207-13. doi: 10.1179/2045772313Y.0000000175. Epub 2014 Jan 3. PMID: 24621046; PMCID: PMC4397203.2. Ojha R, Singh A, George J, Chandy BR. Neuromodulation of spinal reflex pathway for the treatment of detrusor overactivity by medial plantar nerve stimulation at surface of sole of foot in patients with spinal cord injury. J Neurosci Rural Pract. 2023 Jul-Sep;14(3):495-500. doi: 10.25259/JNRP_27_2023. Epub 2023 Aug 16. PMID: 37692814; PMCID: PMC10483192. |