Clinical Study in Healthy Volunteers Evaluating the Performance and Handling of a Urinary Intermittent Catheter With a Newly Developed Swelling Media.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Overall Discomfort During Nurse Catheterization
研究概览
简要总结
Investigation of novel swelling media for CE marked intermittent urinary catheters. The study was a randomized, single blinded, cross-over investigation comparing a novel swelling media with a comparator swelling media in 22 adult, healthy, male volunteers.
详细描述
The CP279 study investigated a novel swelling media for male intermittent urinary catheters. The study was conducted in Denmark and was a single-site, randomized, single blinded, cross-over investigation, testing inferiority of a novel catheter swelling media against a comparator swelling media in 22 adult, healthy, male volunteers.
Each participant was randomized to one of two treatment arms, using a randomization sequence of two (i.e., with two different random options for the order in which the participants tested the two swelling media). The study thus contained two test visits, for which the 22 participants tested the two different swelling media, respectively. There was 4-14 days between the test visits and all catheterizations were performed by trained nurses. Due to a visual difference between the products, it was only possible to blind the subjects.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Written informed consent given
- •Minimum 18 years of age and with full legal capacity
- •Male gender
- •Willing to refrain from using analgesics up to 24 hours prior to catheterization visits
- •Negative urine multistix analysis for erythrocytes (microscopic hematuria)
- •Negative urine multistix analysis for leukocytes and nitrite, or if positive, subsequent negative for bacterial growth in urine culture
排除标准
- •Abnormalities, diseases or surgical procedures performed in the lower urinary tract
- •Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)
- •Participating in other clinical investigations related to urinary tracts system during this investigation (inclusion to termination) or previously participation in this investigation
- •Known hypersensitivity toward any of the investigational device
结局指标
主要结局
Overall Discomfort During Nurse Catheterization
时间窗: Immediately after the procedure/catheterization, up to 5 min.
Discomfort measured for the entire catheterization procedure (performed by nurse), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.
次要结局
- Urination Discomfort After Catheterization(Immediately after first normal void, up to 5 min.)
- Catheter Handling During Insertion(Immediately after the procedure/catheterization, up to 5 min.)
- Touch of Catheter Coating(Immediately after the procedure/catheterization, up to 5 min.)
- Insertion Discomfort During Nurse Catheterization(Immediately after the procedure/catheterization, up to 5 min.)
- Withdrawal Discomfort During Nurse Catheterization(Immediately after the procedure/catheterization, up to 5 min.)
- Catheter Handling During Withdrawal(Immediately after the procedure/catheterization, up to 5 min.)
- Visual Blood During Catheterization(Immediately after the procedure/catheterization, up to 5 min.)
- Microscopic Blood in Catheter-collected Urine(Immediately after the procedure/catheterization, up to 30 min.)