Clinical Study Evaluating Safety of a New Catheter for Urinary Intermittent Catheter in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Discomfort during catheterisation measured by VAS-scale (0-10)
研究概览
简要总结
To evaluate discomfort of a new coating and catheter material compared to SpeediCath (SC)
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 have developed a new intermittent catheters. In this investigation this new test catheter will be compared with SpeediCat 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.
55 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
- Supportive Care
- 盲法
- Single (Investigator)
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
- •Signed informed consent
- •Negative urine stix (erythrocytes, leucocytes and nitrite)
排除标准
- •• Abnormalities, diseases or surgical procedures performed in the lower urinary tract
结局指标
主要结局
Discomfort during catheterisation measured by VAS-scale (0-10)
时间窗: 10 measurements in an 11 week period. 10 min after each catheterisation
A subject is assesing a VAS scale after each catheterisation.
次要结局
- Discomfort during urination post catheterisation(10 measurements in an 11 week period. 10 min after each catheterisation)
- Safety(During the investigation 11 Weeks per subject)
- Haematuria(10 measurements in an 11 week period. 10 min after each catheterisation)
- Handling during insertion, withdrawal(10 measurements in an 11 week period. 10 min after each catheterisation)