Patient Reported Outcomes for Bladder Management Strategies in Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,479
- 试验地点
- 3
- 主要终点
- Neurogenic Bladder Symptom Score (NBSS): comparing change in: CIC, IDC, Voiding, and Surgery
研究概览
简要总结
The investigators goal is to create a better understanding of patient reported outcomes for bladder management strategies (clean intermittent catheterization (CIC), indwelling catheter (IDC) and bladder surgery.
详细描述
Our study is a longitudinal observational study between bladder management strategies, comparing outcomes measured by patient reported questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants with acquired spinal cord injury
- •Participants with neurogenic bladder
- •Participants must be undergoing or starting at least one of the following bladder management treatments at the time of enrollment. a) Clean intermittent catheterization (CIC) b) Have an indwelling catheter (IDC) c) Spontaneous voiding, and d) Have undergone bladder surgery
- •Age 18 or older
- •Willingness and ability to comply with study engagement
- •Able to provide consent
排除标准
- •Degenerative spinal cord issues, such as multiple sclerosis, neuromuscular dysfunction
- •Congenital spinal cord issues, such as spina bifida, myelomeningocele, or cerebral palsy
- •Participants that belong to a vulnerable population (pregnant, prisoners, mentally handicapped, etc)
- •Participants less than 18 years of age
结局指标
主要结局
Neurogenic Bladder Symptom Score (NBSS): comparing change in: CIC, IDC, Voiding, and Surgery
时间窗: Baseline and 1 year longitudinal follow up
The NBSS quantifies bladder symptoms
The Spinal Cord Injury Quality of Life Measurement System Bladder Management Difficulties (SCI-QOL Difficulties): comparing change in: CIC, IDC, Voiding, and Surgery
时间窗: Baseline and 1 year longitudinal follow up
The SCI-QoL Difficulties assesses feelings and psychosocial impact of bladder symptoms
The Spinal Cord Injury Quality of Life Measurement System Bladder Complications (SCI-QOL Complications): comparing change in: CIC, IDC, Voiding, and Surgery
时间窗: Baseline and 1 year longitudinal follow up
The SCI-QoL Complications assesses degree of bladder complications their psychosocial impact
次要结局
- NBSS Incontinence subdomain(Baseline and 1 year longitudinal follow up)
- NBSS Storage and Voiding subdomain(Baseline and 1 year longitudinal follow up)
- NBSS QoL Satisfaction(Baseline and 1 year longitudinal follow up)
- NBSS Consequences subdomain(Baseline and 1 year longitudinal follow up)
研究者
Jeremy Myers
Associate Professor - School of Medicine
University of Utah