The Burden of Intermittent Catheterization in Adult Individuals With Neurogenic Lower Urinary Tract Dysfunction Following Spinal Cord Injury - Part 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Difference in convenience to perform intermittent catheterization between two types of catheters
研究概览
简要总结
This study investigates the burden of intermittent catheterization in adult individuals with neurogenic lower urinary tract dysfunction (NLUTD) following spinal cord injury (SCI).
Individuals will be recruited to compare two types of catheters. Each participant will use a non-hydrophilic catheter at one time point and a hydrophilic catheter at a different time point to perform intermittent catheterization. The order that participants use either a non-hydrophilic or a hydrophilic catheter will be determined randomly. The purpose of the study is to provide evidence for time spent on bladder management (performing intermittent catheterization) as well as consumer satisfaction on using both catheters.
详细描述
NLUTD and its management is of high priority for individuals living with SCI as it significantly reduces quality of life and interferes with their daily life. Intermittent catheterization in individuals with NLUTD following SCI is considered the preferred method of bladder emptying, i.e. gold standard.
Although intermittent catheterization offers reduced risk for urinary tract infection (UTI) compared to other methods of bladder emptying, the burden of complications including UTI and their management remains high. Another important aspect for individuals following SCI is improving quality of life. Since bladder management is a time-consuming and demanding task, reducing the time needed for intermittent catheterization and improving comfort during this procedure, i.e. convenience and ease of handling could significantly benefit quality of life for individuals living with SCI. Therefore, the investigators intend to compare hydrophilic versus non-hydrophilic catheters; time needed to perform intermittent catheterization and the convenience/ease of handling in this present study.
This is a prospective, randomized controlled crossover trial investigating the burden of intermittent catheterization in adult individuals with NLUTD following SCI.
Brief outline of study:
Visit 1 - Screening assessment to determine study eligibility. After providing informed consent, individuals will be assigned a unique study number and the following information will be collected:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male
- •18 years of age or older
- •Presenting with a chronic SCI (i.e. greater than one year post-injury) at any level and with any severity (i.e. American Spinal Injury Association scale grade A to E )
- •Hand function sufficient to perform intermittent catheterization for management of urinary bladder drainage
- •Willing and able to comply with all clinic visits and study-related procedures
- •Must provide informed consent and be able to understand and complete study-related instructions (must be able to understand and speak English)
- •Women must not be pregnant
- •Must not have any urinary diversion procedure, such as bladder augmentation, cystectomy, neo bladder, pouch reservoir, ileal conduit, Mitrofanoff appendicovesicostomy or similar
排除标准
- •In addition to not fulfilling the inclusion criteria:
- •Presence of severe acute medical issue that in the investigator's judgement would adversely affect the individual's participation in the study
- •Individuals who do not perform intermittent catheterization
- •Individuals who are members of the investigational team and immediate family
结局指标
主要结局
Difference in convenience to perform intermittent catheterization between two types of catheters
时间窗: Through study completion, an average of two weeks
To assess the difference in convenience (ease of handling) for two catheters, i.e. using a hydrophilic vs. a non-hydrophilic catheter, as determined by using a survey.
Differences in time needed to perform intermittent catheterization between two types of catheters
时间窗: Through study completion, an average of two weeks
A measure of time (seconds) taken to perform intermittent catheterization using a 13 step pre-determined intermittent catheterization protocol where the first catheter will be different from the later catheter (i.e. hydrophilic vs. non-hydrophilic catheter).
次要结局
未报告次要终点
研究者
Andrei Krassioukov
Principal Investigator
University of British Columbia