| CTRI Number |
CTRI/2026/02/103903 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Burden of urinary incontinence and sexual abnormalities on living standard in individuals suffering from spinal cord injury. |
|
Scientific Title of Study
|
A cross- sectional study on the combined burden of bladder, bowel and sexual dysfunction as predictors of quality of life in individuals with chronic spinal cord injury |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akanksha Srivastava |
| Designation |
PG student |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
Amity University, Sector-125, Noida.
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
8595580609 |
| Fax |
|
| Email |
akkuchinu82@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Sharma |
| Designation |
Professor |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
Amity University, Sector-125, Noida.
Amity University, Sector-125, Noida.
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9760835605 |
| Fax |
|
| Email |
sharmanidhiphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Sharma |
| Designation |
Professor |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
Amity University, Sector-125, Noida.
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9760835605 |
| Fax |
|
| Email |
sharmanidhiphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Amity Institute of Health Allied Sciences |
| Address |
Amity University, Sector-125, Noida |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Self |
Amity University, Sector-125, Noida |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Virendra Vikram Singh |
Kusum Spine And Neurorahbilitation Centre |
D-42, Nangal Dewat Road, Sector-D, Vasant Kunj, New Delhi, Delhi, 110070.
South West
DELHI |
09891666133
ksnr.rehabilitation@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G952||Other and unspecified cord compression, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
NIL |
The participants will be assessed by using Neurogenic bowel dysfunction score for bowel difficulty, SCI-QOL bladder management difficulty for bladder dysfunction, Integrated index of sexual function for sexual dysfunction and WHO-QOLBREF for quality of life. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
individuals diagnosed with neurological level of injury of mid-thoracic T6 to T12 Lumbar L1 to L4 and Lumbo-sacral L5 to S1.
Diagnosed with motor deficit according t the international standards for the neurological classification of SCI with an American spinal injury association impairment scale A to D.
twelve months following the start of the spinal cord injury, post-acute rehabilitation was finished.
married individuals
diagnosed with bowel dysfunction with a minimum duration of six months with neurogenic bowel dysfunction score of 14
In case of female participants how many times a female have conceived?
Willing to complete SCI-QOL bladder management difficulty Neurogenic bowel dysfunction score Integrated index for sexual function and WHO-QOL BREF |
|
| ExclusionCriteria |
| Details |
Acute or subacute SCI less than 12 months since injury
severe cognitive impairment or psychiatric illness interfering with questionnaire completion
Active severe medical illness that may affect the study participation
Recent major pelvic bowel urological or genital surgery within the last 3 months
Pregnant individuals
Participation in another interventional study related to bladder bowel or sexual function
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| World health organization quality of life BREF version |
At the baseline only i.e., on 1st day of assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Spinal cord injury quality of life bladder management difficulty, Neurogenic bowel dysfunction score & integrated index of sexual function. |
One time study on the 1st day of meeting with the participants for 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
24/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/02/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="1" |
|
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 research examines the effects of long-term spinal cord injuries (SCI) on an individual’s everyday life. Numerous people with SCI face multiple health challenges simultaneously, particularly in relation to bladder, bowel, and sexual functions. While these complications have been analyzed separately, this study seeks to evaluate their "combined burden" to determine how they together influence a person’s overall quality of life. Participants will fill out standardized questionnaires regarding their physical and mental health, which will take roughly 30 to 45 minutes. By pinpointing which of these factors most significantly impacts life satisfaction, the research aims to assist healthcare providers and therapists in creating improved, tailored rehabilitation strategies to enhance long-term results for individuals living with chronic spinal cord injuries. |