Optimizing Bladder Management in Neurorehabilitation of Spinal cord injury patients: a Retrospective study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Functional Independence Measure (FIM) score
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •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.
排除标准
- •Patient with uncontrolled Diabetes, chronic kidney disease Patient who is not haemodynamically stable, in sepsis.
- •Patient not willing to participate in the study.
结局指标
主要结局
Functional Independence Measure (FIM) score
时间窗: At baseline, 3months and 6 months
World Health Organization Quality of Life (WHO- QOL)-BREF scale
时间窗: At baseline, 3months and 6 months
次要结局
- Modified Caregiver strain index (MCSI) scale(At baseline, 3months and 6 months)
研究者
Dr Arvind Kumar Sharma
All India Institute of Medical Sciences, Raebareli
