A Randomised, Cross-over, Open-labelled Study Evaluating the Acceptance of Test Catheters Compared to SpeediCath Catheters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort.
研究概览
简要总结
The purpose of this study is to evaluate that the test catheter is no less accepted than the SpeediCath (SC) catheter.
详细描述
See brief summary
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •At least 18 years of age
- •Has normal/impaired sensation in the urethra
- •Self-catheterises at least 4 times per day
- •Has used clean self-intermittent catheterisation for at least 14 days
- •Is able to open and prepare the catheters for catheterisation
- •Has signed the informed consent before any study related-activities.
排除标准
- •Has a symptomatic urinary tract infection as assessed by the investigator
- •Is mentally unstable as assessed by the investigator
研究组 & 干预措施
test intermittent catheter
CH 12 hydrophilic coated catheter
干预措施: test intermittent catheter (Device)
intermittent catheter
CH 12 hydrophilic coated catheter
干预措施: Intermittent catheterization (Device)
结局指标
主要结局
Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort.
时间窗: 14 days
Participants were to test the catheter by self-catheterising a minimum of 4 catheters each day for 14 days. At the end of each study period participants were asked to indicate how they would rate the discomfort experienced during the catheterisation procedures. Discomfort was measured by the participants own rating of discomfort on a VAS scale from 0 (no discomfort) to 10 (worst imaginable discomfort)
次要结局
未报告次要终点