NCT02966015已完成不适用
Product Evaluation of a Newly Developed Intermittent Catheter.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 主要终点
- Number of Participants Successfully Able to Insert Catheter
研究概览
简要总结
The aim of the study is to investigate the navigation of a newly developed catheter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- Male
- 接受健康志愿者
- 否
入选标准
- •Male and at least 18 years
- •Has used Intermittent self-catheterization at least 3 months
- •Has normal to slightly reduced hand mobility
- •Use catheter size CH12 or CH14 (must use same size during product evaluation)
排除标准
- •Currently receiving treatment for urinary tract infection
- •Currently receiving chemotherapy
研究组 & 干预措施
Testing the new Coloplast Test catheter
Experimental
The subjects used the new Coloplast Test catheter for 1 week
干预措施: Coloplast test catheter (Device)
结局指标
主要结局
Number of Participants Successfully Able to Insert Catheter
时间窗: 1 week
The subjects had to evaluate if it was possible to insert and navigate the Coloplast Test catheter through urethra by the 5-point Likert question: "How did you find the catheter navigates through the urethra during insertion" ( Very easily, Easily, Neither/nor, Difficultly, Very difficultly, Not possible). The catheterization was considered successful if it was possible to insert the catheter, meaning that ifthey selected any other answer than 'not possible'.
次要结局
未报告次要终点
研究者
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