| CTRI Number |
CTRI/2026/01/100343 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
04/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Urodynamic study of patients with bladder dysfunction following primary spinal cord tumours : a prospective study |
|
Scientific Title of Study
|
Urodynamic profile of patients with neurogenic bladder dysfunction following primary spinal cord tumours : a prospective 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 |
DARSHANA S |
| Designation |
Post Doctoral Fellow |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
Room no 1, Neurorehabilitation OPD, Department of Neurological Rehabilitation, National Institute of Mental Health and Neurosciences (NIMHANS) Hospital, Hombegowda, Bangalore, Karnataka , Pin 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
9400746261 |
| Fax |
|
| Email |
darshanasurendran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anupam Gupta |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Room no 1, Neurorehabilitation OPD, Department of Neurological Rehabilitation, National Institute of Mental Health and Neurosciences (NIMHANS) Hospital, Hombegowda, Bangalore, Karnataka , Pin 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
9481207449 |
| Fax |
|
| Email |
drgupta159@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DARSHANA S |
| Designation |
Post Doctoral Fellow |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Room no 2, Neurorehabilitation OPD, Department of Neurological Rehabilitation, National Institute of Mental Health and Neurosciences (NIMHANS) Hospital, Hombegowda, Bangalore, Karnataka , Pin 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
9400746261 |
| Fax |
|
| Email |
darshanasurendran@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIMHANS HOSPITAL |
| Address |
Hombegowda, Bangalore, Pin 560029, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Darshana S |
National Institute of Mental Health and Neurosciences (NIMHANS) Hospital |
Room no 2, Neurorehabilitation OPD, Department of Neurological Rehabilitation
Bangalore
KARNATAKA |
9400746261
darshanasurendran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Mental Health and Neurosciences Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C720||Malignant neoplasm of spinal cord, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Operated cases of non-traumatic spinal cord injury due to primary spinal cord tumour
2. Neurogenic bladder symptoms
3. Age between 18 – 70 years
4. Willing to participate
|
|
| ExclusionCriteria |
| Details |
1. Non operated cases of primary spinal tumours
2. Traumatic and other non-traumatic causes of SCI
3. No bladder symptoms
4. Other coexisting bladder and urethral pathology like bladder carcinoma, urethral stricture
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Urodynamic parameters (filling and voiding cystometry)
2. American spinal injury association impairment scale
3. Neurological level of injury
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bladder wall thickness |
baseline |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
20/01/2026 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study is to understand the urodynamic profile of patients with neurogenic bladder dysfunction following spinal cord tumours and to find correlation between time since injury, severity of injury, level of injury with bladder pattern & also to find correlation between bladder wall thickness and bladder pattern in this population. As there are different types of neurogenic bladder patterns, it helps to predict the specific bladder pattern and the chronic bladder wall changes with the help of clinical findings of the patient. |