A Randomized, Crossover Study Confirming Performance of a New Single-use Compact Intermittent Catheter vs. Infyna Chic in a Pop-ulation of Adult Female Intermittent Catheter Users.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP)
研究概览
简要总结
The study is a randomised, single-blinded, controlled crossover study. The total study duration for the individual subject will be between two days - two weeks, consisting of three site visits. Visits 0 and 1 can be performed on the same day. Visit 2 can be performed the day after visit 1. For visit 1 and 2, catheterizations will be performed in a hospital setting by a health care professional for bladder emptying assessment and collection of urine samples for haematuria assessment. A sub-group of subjects (all enrolled subjects at DK sites) will be asked to conduct a self-catheterization at visit 2 after hcp catheterization and evaluate discomfort and PVR.
The total study duration for the individual subject will be up to 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Is Female
- •Is at least 18 years of age and has full legal capacity
- •Has signed an informed consent form
- •Has used clean intermittent self-catheterisation (CISC) (CH12 or CH14) for at least one month up to inclusion
- •Is using intermittent self-catheterisation for a minimum of 3 times per day for bladder emptying
- •Has used a compact catheter 50% of the time (or more) for the last two weeks prior to entering the study
- •Has the ability (assessed by investigator) and willingness to follow study procedures or is able to use a compact catheter assessed by investigator
排除标准
- •Is participating in any other clinical study during this investigation
- •Has previously participated in this study
- •Has symptoms of urinary tract infection at time of inclusion, as judged by the investigator (if the patient recovers within the recruitment period, a second inclusion is allowed, under a different subject id)
- •Is an individual with a history of - suspected to be - or showing signs of producing an excessive amount of mucus or large/clustered sediments or debris
- •Has any known allergies towards ingredients in the investigational device
- •Is pregnant
- •Is breastfeeding
结局指标
主要结局
Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP)
时间窗: At Visit 1 and Visit 2
Measure residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile, \[mL\]
次要结局
- Number of Flowstops (Catheterisation Performed by a Healthcare Professional)(At Visit 1 and Visit 2)
- Residual Volume Post Catheterisation(At Visit 1 and Visit 2)
- Number of Adverse Events(At Visit 1 and Visit 2)