User Preference Study to Compare a 40cm Intermittent Catheter to a 30cm Intermittent Catheter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 4
- 主要终点
- Percentage of Participants
研究概览
简要总结
This is an unblinded, multi-center, randomized, controlled, cross-over study assessing wheel-chair bound, male user preference and catheter characteristics of two intermittent urinary catheters. Subjects enrolled in the study will be randomized to order of catheter use. Individual participation will consist of approximately 1 week of product use. The null hypothesis to be tested is there no difference between catheters.
详细描述
- is male and at least 18 years of age.
- is self-catheterizing at least 3 times a day.
- has been performing catheterizations for at least 2 months.
- is wheelchair bound.
- is able to use a size 12 or 14 French straight catheter.
- is willing and able to follow the study protocol and Investigator's instructions.
- is in the opinion of the Investigator, qualified to participate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •is male and at least 18 years of age
- •is self-catheterizing at least 3 times a day
- •has been performing catheterizations for at least 2 months
- •wheelchair bound
- •is able to use a size 12 or 14 French straight catheter
- •is willing and able to follow the study protocol and Investigator's instructions
- •is, in the opinion of the Investigator, qualified to participate
排除标准
- •has cognitive impairments that preclude completion of study protocol
- •cannot communicate as determined by the Investigator
- •has an existing medical condition that, in the opinion of the investigator, would interfere with the subject's ability to participate or in the interpretation of the results
- •has a symptomatic urinary tract infection determined by interview
- •has a retracted penis
- •has participated in a study during the previous 30 days involving catheterization
- •has been diagnosed with an enlarged prostate
- •has urethral strictures, false passages, or urethral obstruction
研究组 & 干预措施
30 cm Intermittent Catheter
Intervention was the test of a 30 cm catheter compared to standard commercial 40 cm catheter in a cross-over design.
干预措施: 30 cm Intermittent Catheter (Device)
40 cm Intermittent Catheter
Active comparator 40 cm commercial catheter was compared to experimental 30 cm catheter in a cross-over design.
干预措施: 40 cm Intermittent Catheter (Device)
结局指标
主要结局
Percentage of Participants
时间窗: 1 week
Percentage of participants that preferred the 40 cm catheter
次要结局
- Assessment of Ease of Use Characteristics(1 week)