FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/092144 [Registered on: 01/08/2025] Trial Registered Prospectively
Last Modified On: 31/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective study 
Study Design  Other 
Public Title of Study   Study to see effect of different methods of managing bladder issues in patients with spinal cord injury 
Scientific Title of Study   Optimizing Bladder Management in Neurorehabilitation of Spinal cord injury patients: a Retrospective 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  Dr Arvind Kumar Sharma 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Raebareli 
Address  Room 22/28, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Munshiganj, Madhupuri, Uttar Pradesh-229405.

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  6388930133  
Fax    
Email  arvindkgmu25@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arvind Kumar Sharma 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Raebareli 
Address  Room 22/28, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Munshiganj, Madhupuri, Uttar Pradesh-229405.


UTTAR PRADESH
229405
India 
Phone  6388930133  
Fax    
Email  arvindkgmu25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arvind Kumar Sharma 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Raebareli 
Address  Room 22/28, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Munshiganj, Madhupuri, Uttar Pradesh-229405.


UTTAR PRADESH
229405
India 
Phone  6388930133  
Fax    
Email  arvindkgmu25@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Raebareli 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Raebareli, Uttar Pradesh 
Address  All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arvind Kumar Sharma  All India Institute of Medical Sciences, Raebareli, Uttar Pradesh  Room 22/28, Ground floor, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd,Munshiganj,Madhupuri, Uttar Pradesh 229405
Rae Bareli
UTTAR PRADESH 
6388930133

arvindkgmu25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC), AIIMS Raebareli, Uttar Pradesh, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G822||Paraplegia,  
 
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  Patient with spinal cord injury having neurogenic bladder.
Age of the patient 18-70 years.
Patient willing to give consent to participate in the study
 
 
ExclusionCriteria 
Details  Patient with uncontrolled Diabetes, chronic kidney disease
Patient who is not haemodynamically stable, in sepsis.
Patient not willing to participate in the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Functional Independence Measure (FIM) score
World Health Organization Quality of Life (WHO- QOL)-BREF scale
 
At baseline, 3months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Modified Caregiver strain index (MCSI) scale  At baseline, 3months and 6 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   11/08/2025 
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)   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  

TITLE: Optimizing Bladder Management in Neurorehabilitation of Spinal cord injury patients: a Retrospective study

Aim: To evaluate various bladder management strategies used in neurorehabilitation in spinal cord injury patients.

Primary objectives

To assess and compare the various bladder management techniques among spinal cord injury patients.

To determine the relationship between injury characteristics (level and completeness of spinal cord injury) and the choice or success of bladder management techniques.

To assess and compare the challenges in terms of complications and barriers faced by SCI patients with neurogenic bladder using different methods of voiding.

To evaluate adherence to bladder care protocols and its correlation with rehabilitation outcomes.

Secondary objectives

To assess the improvement in functional independence in performing activities of daily living (ADLs) among SCI patients with neurogenic bladder undergoing neurorehabilitation.

To compare changes in quality of life (QOL) among SCI patients with neurogenic bladder managed with different methods of bladder voiding.

To assess the impact of caregiver support and involvement on the effectiveness and adherence to bladder management techniques in SCI patients with neurogenic bladder.

To evaluate and compare the level of caregiver burden associated with various bladder management techniques used in SCI patients with neurogenic bladder.

To evaluate the effect of home environment and living situation on bladder management outcomes and adherence to among SCI patients with neurogenic bladder.

Rationale:

Bladder management is a critical aspect of neurorehabilitation in SCI, aimed at preserving renal function, preventing infections, achieving continence, and improving quality of life. Several management options exist, including clean intermittent catheterization (CIC), indwelling urethral catheterization, suprapubic catheterization, reflex voiding with or without pharmacological agents, and surgical interventions.

Indwelling catheters (either urethral or suprapubic) are commonly used for bladder management in SCI patients. While they provide continuous drainage and are easy to manage, indwelling catheters are associated with a higher risk of urinary tract infections, catheter blockage, bladder spasms, and urethral trauma. Long-term use can lead to complications such as bladder stones, hematuria, and increased healthcare costs. Despite these drawbacks, indwelling catheters remain a practical option in certain clinical scenarios, especially for patients with limited mobility or poor hand function. Clean intermittent catheterization (CIC) was introduced in 1972 by Lapides and is considered as the gold standard to regularly, efficiently and autonomically empty the bladder in the case of neurogenic bladder for SCI patients. CIC is a nonsterile but “clean” technique for the management of chronic retention and infection.

During CIC, the patient or caregiver introduces a catheter transurethrally into the bladder and drains the urine through the catheter into a urine bag or directly into the toilet. Thus, in this study, we would like to assess the compliance, challenges in social life, and community integration, perspectives and experiences of SCI patients in using CIC as a long term option for neurogenic bladder.

This study is undertaken to evaluate the effectiveness, complications, and patient outcomes associated with different bladder management strategies, particularly focusing on the use of indwelling catheters versus other methods, in spinal cord injury patients undergoing neurorehabilitation. By retrospectively analyzing real-world clinical data, we aim to identify best practices that optimize bladder care, reduce complications, and improve the overall quality of life for this vulnerable population. The findings will help in clinical decision-making, patient and caregiver education and counselling regarding appropriate methods of voiding in the management of neurogenic bladder as per the patients’ need according to their functional status and architectural barriers in real-life situation.

Materials and Methods

Study design: Retrospective study

Study duration: 6 months

Study setting: Department of Physical Medicine and Rehabilitation (PMR) at All India Institute of Medical Sciences (AIIMS) Raebareli

Inclusion criteria:

Patient with spinal cord injury having neurogenic bladder.

Age of the patient 18-70 years.

Patient willing to give consent to participate in the study

Exclusion criteria:

Patient with uncontrolled Diabetes, chronic kidney disease

Patient who is not haemodynamically stable, in sepsis.

Patient not willing to participate in the study.

Procedure: Patients of SCI with neurogenic bladder who were admitted in the In-patient Department of Physical Medicine and Rehabilitation at AIIMS Raebareli from May 2022 till May 2025 and were taught CIC included in the study. After taking informed consent from the patients, their demographic details will be recorded in the working case proforma, along with time since injury, neurological level of injury (NLI), ASIA impairment scale.

Change in Functional Independence Measure (FIM) score for the subjects will be recorded to assess the change in ability to carry out ADL. Change of quality of life (QOL) will be done using World Health Organization Quality of Life (WHO- QOL)-BREF scale. Change in caregiver strain will be evaluated using Modified Caregiver strain index (MCSI) scale. ICDQ (intermittent catheterization difficulty questionnaire will be used to assess the difficulties and barriers faced by patients while doing CIC.

Statistical Analysis:

The collected data will be entered in Microsoft Excel and then will be analysed and statistically evaluated using SPSS-PC-25 version.

 

 
Close