Exploratory Study Investigating the Acute Effect of Intermittent Catheterization on the Bladder Mucosa of Healthy Volunteers With a Prototype Micro Hole Zone Catheter Compared to a Conventional 2-eyelet Catheter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Change in Appearance of the Bladder Mucosa (∆=Pre-catheterisation at Baseline and Post-catheterization and Visit 2) Rated on a 4-point Scale.
研究概览
简要总结
This investigation is a randomized, single-blinded, parallel, single-center investigation. In total, up to 50 subjects (40 completers) were included and each subject had two test visits overseen by the Principal Investigator (PI), or designee. Each subject were enrolled in the investigation, which lasted up to 3 days (if Day 0 and Day 1 were not on same day). The subjects were randomly assigned to test either the prototype product or the comparator product, with at least 20 subjects assigned to each product.
详细描述
This investigation was a randomized, single-blinded, parallel, single-center investigation. Up to 50 subjects (40 completers) will be included and each subject will have two test visits overseen by the Principal Investigator (PI), or designee. Each subject will be enrolled in the investigation, which can be up to 3 days (if Day 0 and Day 1 are not on same day). The subjects will be randomly assigned to test either the prototype product or the comparator product, with at least 20 subjects assigned to each product. The subjects will undergo cystoscopy and catheterization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Has given written informed consent
- •Is at least 18 years and have full legal capacity
- •Has a negative urine Multistix dipstick test for erythrocytes (haematuria)
排除标准
- •Has used an internal urinary catheter or cystoscopy within the past month
- •Has prior history of bladder surgery
- •Is symptomatic and/or on medication for overactive bladder
- •Has evidence of ongoing, active, symptomatic urinary tract infection (UTI) (assessed by PI, or delegate)
- •Is pregnant and/or breast-feeding
- •Is participating in other clinical investigations during this investigation
- •Is menstruating during study period
结局指标
主要结局
Change in Appearance of the Bladder Mucosa (∆=Pre-catheterisation at Baseline and Post-catheterization and Visit 2) Rated on a 4-point Scale.
时间窗: 2 days
Change in appearance of the bladder mucosa (∆=pre-catheterisation at baseline and post-catheterization and visit 2) rated on a 4-point scale. The 4-point scale defined as such: 1. no lesions evident; 2. minor mucosal and blood vessel lesions; 3. major blood vessel lesions, and 4. major mucosal and blood vessel lesions,
次要结局
未报告次要终点