NCT04635566已完成不适用
Pharmacological Enhancement for Nocturnal Incontinence in Orthotopic Bladder Substitute. A Randomised Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- assess the 3-months nocturnal continence rate
研究概览
简要总结
In this randomised trial, we hypothesised that mebeverine could enhance nocturnal continenece of Orthotopic Bladder Substitute (OBS) patients by decreasing the frequency and reduce maximum amplitude of uninhibited contractions of OBS ileum, and consequently it would increase the OBS capacity
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- 否
入选标准
- •nocturnal enuresis
排除标准
- •daytime incontinence
- •Orthotopic Bladder Substitute (OBS) reconstruction surgery ≤2 years
- •chronic kidney disease
- •local tumor recurrence
- •adjuvant chemotherapy and/or radiotherapy
- •chronic retention requiring use of clean intermittent catheterization or indwelling urethral catheterization
- •suspected or known narrow-angle glaucoma
- •sensitivity to mebeverine.
研究组 & 干预措施
Mebeverine
Active Comparator
Mebeverine 200 mg sustained-release (Coloverine® SR, Chemipharm pharmaceutical, Egypt) one time/day at the evening.
干预措施: mebeverine 200 mg sustained-release (Coloverine® SR, Chemipharm pharmaceutical, Egypt) one time/day at the evening. (Drug)
Placebo
Placebo Comparator
Placebo one time/day at the evening.
干预措施: Placebo (Drug)
结局指标
主要结局
assess the 3-months nocturnal continence rate
时间窗: 3 months
comparing Urinary function domain from the bladder cancer index (BCI) questionnaire
次要结局
未报告次要终点
研究者
研究点 (1)
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