Indwelling Urinary Catheterization Versus Clean Intermittent Catheterization for the Management of Acute Urinary Retention: Multicenter, Randomized, Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Assessment of the quality of life
研究概览
简要总结
This is a prospective, comparative, multicenter, randomized controlled trial. The aim of this study is to compare the efficacy, safety and quality of life within patients with acute urinary retention managed by the intermittent catheterization compared or indwelling Foley catheter.
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
- None
入排标准
- 年龄范围
- 21 Years 至 95 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men with acute urinary retention due to prostatic hyperplasia
排除标准
- •Patient's with serious conditions and incapacity
- •Previous urethral or prostate surgery.
- •Urethral stricture.
- •Urethrorrhagia.
- •Injuries of urethra and perineum.
- •Attempts of bladder catheterization within 15 days before the acute urinary retention episode.
- •Urinary tract infection.
- •Neurogenic bladder.
- •Chronic urinary retention with a bladder volume of more than 1 liter.
- •Obstructive uropathy due to the acute urinary retention.
研究组 & 干预措施
intermittent catheterization (group B)
Procedure/Surgery: The acute urinary retention in group B is managed by clean intermittent catheterization along with alpha-blockers during 3 period. After 3 days the ability of spontaneous voiding is assessed and registered as an outcome.
干预措施: intermittent catheterization (Procedure)
intermittent catheterization (group B)
Procedure/Surgery: The acute urinary retention in group B is managed by clean intermittent catheterization along with alpha-blockers during 3 period. After 3 days the ability of spontaneous voiding is assessed and registered as an outcome.
干预措施: alpha-blockers (Drug)
Catheter Foley (group A)
The acute urinary retention in group A is managed by trial without catheter along with alpha-blockers during 3 period. After 3 days the indwelling Foley catheter is removed and ability of spontaneous voiding is assessed and registered as an outcome.
干预措施: trial without catheter (Procedure)
Catheter Foley (group A)
The acute urinary retention in group A is managed by trial without catheter along with alpha-blockers during 3 period. After 3 days the indwelling Foley catheter is removed and ability of spontaneous voiding is assessed and registered as an outcome.
干预措施: alpha-blockers (Drug)
结局指标
主要结局
Assessment of the quality of life
时间窗: 2 months
Assessment of the quality of life according to the SF-36 questionnaire on the first, second, or third day after the start of intermittent catheterization
次要结局
- Assessment of the restoration of self-urination.(2 months)