Comparative Study of Two Different Urine Catheters.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Discomfort Measured on the Visual Analog Scale (VAS)
研究概览
简要总结
The purpose of this study is to evaluate the safety of a new developed catheter in comparison with an catheter on the market. The study is randomised.
详细描述
Intermittent catheterization is the preferred method for emptying the bladder in patients with spinal cord injury and neurogenic bladder dysfunction.
Coloplast has developed a new intermittent catheter. In this investigation this new test catheter will be compared with SpeediCath by assessing discomfort and pain associated with catheterization of healthy men. The reason for choosing healthy men is that many catheter users do not have full feeling in their urethra and therefore can not assess the discomfort.
Healthy men who are ≥ 18 years and have no signs of urinary tract infection and do not have abnormalities, disease or have had operational interventions in the urinary tract will be included. They are recruited through advertisements on the website www.forsoegsperson.dk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •18 years or older
- •signed informed Consent,
- •Neg. urine multistix
排除标准
- •Abnormalities,
- •diseases or surgical procedures performed in the lower urinary-tract
结局指标
主要结局
Discomfort Measured on the Visual Analog Scale (VAS)
时间窗: 10 minutes after each catheterisation at visit 1 and at visit 2 which is 5-25 days after visit 1
Outcome measured on a 10 cm Visual Analog Scale ranging from "no discomfort" (0cm) to "worst thinkable discomfort" (10cm).
次要结局
- Irritation During Voiding After Catheterization(10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1)
- Ease of Use Measured on a 5 Point Scale: Insertion Effort(10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1)
- Ease of Use Measured on a 5 Point Scale: Withdrawal Effort(10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1)
- Visible Blood(10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1)
- Haematuria(2 hours after catheterisation at visits 1 and 2)