NCT04672993已完成不适用
Exploratory Study of a New Urine Collection Device for Men
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
- 20
- 试验地点
- 1
- 主要终点
- Percentage of Participants That Found the Product to be Comfortable to Wear
研究概览
简要总结
The aim of the investigation is to evaluate the subjects experience of a new collection device for men.
An open-labelled, single arm study design was chosen for this investigation with a duration of 1 week + up to 3 days extra.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Have given written informed consent
- •Be at least 18 years of age and have full le-gal capacity
- •Suffering from urinary incontinence equiva-lent to using up to 6 pads or 2 diapers per day
- •Have had current incontinence issues for at least 3 months
- •Able to understand patient information and able to change the product himself
- •Up to 6 of the subjects can be users who are using an intermittent catheter due to re-tention, but who are also dribble inconti-nent in-between catheterizations, and hence need a product to handle the inconti-nence.
- •Able to fit the test product.
排除标准
- •If experiencing incontinence less than once per week
- •Bedridden, using wheelchair or using a walking aids regularly
研究组 & 干预措施
Urine Collection Device for Men
Experimental
Test of Urine Collection Device for Men for 7 (+/- 3/0 days).
干预措施: Urine collection device for men (Device)
结局指标
主要结局
Percentage of Participants That Found the Product to be Comfortable to Wear
时间窗: One week
Questionnaire used to measure the frequency of success in support of "comfortable": "How comfortable was the product to wear?". The question was asked at the end of the trial.
次要结局
未报告次要终点
研究者
研究点 (1)
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