Exploratory Investigation on Performance and Safety of Newly Developed Intermittent Catheters in Female Users of Intermittent Catheters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Residual Urine at 1st Flow-stop During Nurse Catheterization
研究概览
简要总结
Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for females with a comparator catheter.
详细描述
The CP324 study investigated a novel non-CE marked intermittent catheter, designed in two different variants, Variant 1 and Variant 2, respectively, and was conducted in Denmark. The study was a randomized, single blinded, cross-over investigation comparing the two new variant catheters with a comparator catheter in 15 female IC users.
For each participant, the study thus contained three test visits/treatment arms (Comparator, Variant 1 and Variant 2, respectively), to which the 15 participants were randomized using a randomization sequence of six (i.e., there were six different random options for the order in which the participants tested the three catheters). There were 4-14 days between the test visits.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Minimum 18 years of age and with full legal capacity
- •Daily intermittent catheterization for bladder management, with at least two catheters used on average pr. day, during the last 3 months
- •Ability to self-catheterize
- •Written informed consent, signed letter of authority and signed secrecy agreement given
排除标准
- •Breastfeeding
- •Pregnancy (based on pregnancy test - urine)
- •Participation in any other clinical study during this investigation
- •Symptoms of urinary tract infection as judged by the investigator
- •Any know allergies towards ingredients in the products
- •Relevant medical history that would prevent the subject from participation (investigators judgement)
结局指标
主要结局
Residual Urine at 1st Flow-stop During Nurse Catheterization
时间窗: Immediately after the procedure/catheterization, up to 5 min.
The residual urine at 1st flow-stop during nurse catheterization (i.e., catheterization performed by the nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop.
Residual Urine at 1st Flow-stop During Self-catheterization
时间窗: Immediately after the procedure/catheterization, up to 5 min.
The residual urine at 1st flow-stop during self-catheterization (i.e., catheterization performed by the participant) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop.
次要结局
- Post-void Residual Urine After Self-catheterization(Immediately after the procedure/catheterization, up to 15 min.)
- Insertion Discomfort During Nurse Catheterization(Immediately after the procedure/catheterization, up to 5 min.)
- Urination Discomfort During Self-catheterization(Immediately after the procedure/catheterization, up to 5 min.)
- Withdrawal Discomfort During Self-catheterization(Immediately after the procedure/catheterization, up to 5 min.)
- Post-void Residual Urine After Nurse Catheterization(Immediately after the procedure/catheterization, up to 15 min.)
- Withdrawal Discomfort During Nurse Catheterization(Immediately after the procedure/catheterization, up to 5 min.)
- Urination Discomfort During Nurse Catheterization(Immediately after the procedure/catheterization, up to 5 min.)
- Overall Discomfort During Self-catheterization(Immediately after the procedure/catheterization, up to 5 min.)
- Overall Discomfort During Nurse Catheterization(Immediately after the procedure/catheterization, up to 5 min.)
- Insertion Discomfort During Self-catheterization(Immediately after the procedure/catheterization, up to 5 min.)