NCT01523743已完成4 期
Quality of Life Intermittent Catheter Study - A Prospective, Randomized, Cross-over, Multicenter Study Comparing Quality of Life Using Compact Versus Standard Urinary Intermittent Catheters
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 11
- 主要终点
- Quality of Life (0-100 Point)
研究概览
简要总结
The purpose of this study is to compare compact intermittent catheters with standard coated intermittent catheters with regard to quality of life, using the Intermittent Self-Catheterisation Quality of life Measure.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is at least 18 years of age
- •Has given written informed consent
- •Has neurogenic bladder dysfunction
- •Has used coated intermittent catheter as primarily bladder emptying method for at least 6 months
- •Is able to self-catheterise
- •Is able to use SpeediCath® compact catheters
- •If spinal cord injury subject, injury must have occurred more than 12 months ago
- •Covered by Social security system
排除标准
- •Has used SpeediCath® compact catheters (not including screening for this investigation)
- •Is admitted to rehabilitation centre
- •Subjects using primarily catheter sets
- •Is pregnant or breast-feeding
研究组 & 干预措施
Compact catheter
Experimental
Compact intermittent catheter
干预措施: SpeediCath Compact (Device)
Standard Care
Active Comparator
Standard Care: Coated intermittent catheter normally used by subject
干预措施: Standard care (Device)
结局指标
主要结局
Quality of Life (0-100 Point)
时间窗: 6 weeks
Difference in intermittent self-catheterisation quality of life measure, comparing compact versus standard urinary intermittent catheters The range of the scale is 0-100 where a high score indicating a high level of Quality of Life.
次要结局
未报告次要终点
研究者
研究点 (11)
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