NCT01056666已完成4 期
Evaluation de l'Impact Sur la qualité de Vie de l'Utilisation d'un système Collecteur Conveen( étuis pénien Conveen Optima Avec Poches de Recueil Conveen) Chez Des Hommes Souffrant d'Une Incontinence Urinaire modérée ou sévère, Comparativement à Leur Protection Absorbante Habituelle
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 主要终点
- Impact on quality of life
研究概览
简要总结
The objective of this investigation is to asses with validated scales, the impact on the quality of life of men suffering of moderate to severe incontinence of the use of Conveen Optima urisheath in comparison with their usual absorbent protection.
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
- 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
- •Patient over 18
- •Out clinic patient
- •Patient using absorbent protection for his urinary incontinence
- •Moderate to severe urinary incontinence (1 hour pad test > 10g)
- •All kind of stable urinary incontinence
- •Patient able to apply himself the device
- •Patient able to understand the questions
- •Patient having given his informed consent
- •Patient whose overall treatment for his urinary incontinence is not modified during the study
排除标准
- •Patient having a retracted penis
- •Patient having skin problem on the penis
- •Patient using urisheaths
- •Bedridden patient
- •Institutionalized patient
- •Patient with indwelling catheter or under intermittent catheterisation
- •Patient with fecal incontinence leading to the use of absorbent protection
- •Patient suffering of urinary tract infection
结局指标
主要结局
Impact on quality of life
时间窗: Days 0, 15, 30
次要结局
- Efficacy (leakages)(days 13, 14, 15 and days 28, 29, 30)
研究者
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