Intermittent Catheterization in Spinal Cord Injured Men
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Residual Volume Less Than 100ml
研究概览
简要总结
The aim of this investigation is to study how the position of different catheters affect drainage of the bladder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 否
入选标准
- •Has given written informed consent
- •Is at least 18 years of age and has full legal capacity
- •Is a male
- •Has an Spinal Cord Injury diagnosis
排除标准
- •Participating in other interventional clinical investigations or have previously participated in this investigation
- •Known hypersensitivity toward any of the test products
- •Serious abdominal scars
- •Symptoms of urinary tract infections
结局指标
主要结局
Residual Volume Less Than 100ml
时间窗: 2-4 hours
The primary endpoint was "Residual volume less than 100 ml (Yes/No)" assessed after catheterization when placed at fixed heights (25, 20, 15, 10 and 0 cm) over the wheelchair seat. Prior to the catheterization corresponding to height 25 cm, a solution was instilled into the bladder to ensure a volume equal to 300 ml. The residual volume at height 25 cm was then calculated as 300 ml minus the volume emptied during catheterization. The residual volume corresponding to height 20 cm was calculated as the residual volume corresponding to height 25 minus the additional volume emptied at height 20. The residual volume corresponding to height 15, 10 and 0 cm were derived similarly. Calculated residual volumes were negative, likely due to faulty ultrasound scans performed on subjects in sitting position. Consequently, the changes in bladder volumes, re-worded from "300ml - collected volume \<100ml" to "collected volume \> 200ml", were used to interpret the primary endpoint.
次要结局
未报告次要终点