A Double-Blind Randomized Parallel Group Study of Alfuzosin 10mg OD Versus Placebo in the Management of Acute Urinary Retention in Patients With a First Episode Due to Benign Prostatic Hyperplasia (BPH)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 800
- 主要终点
- Successful voiding in initial period (using an active voiding trial)
研究概览
简要总结
To assess the efficacy of alfuzosin 10mg OD in the management of acute urinary retention associated with BPH.
To assess the safety of alfuzosin in this population and health care consumption.
详细描述
Double-blind, placebo controlled, randomized Multicenter, Phase III study comparing 2 parallel groups (alfuzosin 10mg OD or placebo) in patients with a first episode of acute urinary retention related to BPH.The acute episode is managed with catheterization and with study drug treatment for 2 to 3 days, followed by an active voiding trial to assess the patients' ability to void after catheter removal.
Those patients who successfully void will continue their randomized treatment for a total treatment duration of 6 months. For all patients who are prematurely withdrawn during the study, a post-study (clinic or phone) visit will be performed for collection of health care consumption data.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male aged over 50 years
- •Having given his written consent
- •Presenting with a first episode of painful acute urinary retention related to BPH
- •With a catheterized urine volume between mL and mL at the time of retention
排除标准
- •Associated urological diseases / troubles (e.g. infection or surgery of prostate, urinary retention f neurogenic origin
- •Iatrogenic causes of urinary retention
结局指标
主要结局
Successful voiding in initial period (using an active voiding trial)
No relapse during the 6 month treatment period
No need / indication for surgery during the initial or 6 month treatment periods
次要结局
- To assess the safety of alfuzosin in this population, and health care consumption