Explorative Study Investigating the Urinary Bladder and Prostate During Intermittent Catheterization in Healthy Male Adults by Use of MR-scanning.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Bladder behavior
研究概览
简要总结
Explorative study investigating the urinary bladder and prostate during intermittent catheterization in healthy male adults by use of MR-scanning.
详细描述
12 healthy male adults will be enrolled in the investigation. The study includes one study visit where MR-scans of the bladder and prostate will be performed during normal voiding as baseline measurement followed by measurements during emptying of the bladder with an intermittent catheter (SpeediCath CH12 standard male intermittent catheter).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Has given written informed consent
- •Be at least 18 years of age and have full legal capacity
排除标准
- •Participate in any other clinical investigation
- •Has symptoms of UTI (Investigator's judgement)
- •Has known abnormalities and/or diseases in the bladder and/ or the lower urinary tract
- •Has had previous disease or surgery in lower urinary tract
- •Has any MR-scanning contraindication - according to "MR check list"
研究组 & 干预措施
Intermittent catheter
Coloplast SpeediCath CH12 male intermittent catheter
干预措施: Coloplast SpeediCath CH12 standard male intermittent catheter (Device)
结局指标
主要结局
Bladder behavior
时间窗: Within 1 year after termination
Evaluate bladder behavior when emptying the bladder with an intermittent catheter evaluated by performance of 3D and dynamic MRI
Bladder morphology
时间窗: Within 1 year after termination
Evaluate bladder morphology and behavior during emptying of the bladder by performance of 3D and dynamic MRI
次要结局
未报告次要终点