NCT00453908终止3 期
Does Alfuzosin OD vs. Placebo in Male Patients Facilitate Spontaneous Voiding During Clean Intermittent Self-Catheterization Following Acute Urinary Retention?
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Number of patients with satisfying spontaneous voiding after 14 days measured by bladder scan at day 14.
研究概览
简要总结
The primary objective of the study is to investigate if 14 days of treatment with Alfuzosin compared to placebo, will increase the number of patients with satisfying spontaneous voiding after acute urinary retention treated with Clean Self-Catheterization.
Furthermore is investigated the safety of the medical treatment and self-catheterization.
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
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
- •Men with acute urinary retention and catheterized
- •Benign hypertrophia of prostate
- •Patient is diagnosed in Emergency room or at a acute hospitalization
排除标准
- •Known prostate cancer
- •Prior urinary retention within 30 days
- •Urinary retention occurring in relation to surgery
- •Blood in urine
- •Difficult or impossible catheterization
- •Fever > 38 degree Celsius
- •Decreased kidney function
- •Permanent catheter > 14 days
- •Treatment with alfa 1 blocker within 30 days
- •Meeting contraindications to treatment with Alfuzosin
- •Treatment with other drugs for urinary problems
- •The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial.
结局指标
主要结局
Number of patients with satisfying spontaneous voiding after 14 days measured by bladder scan at day 14.
次要结局
- Number of days until termination of self catheterization
- Number of patients with urinary infection requiring treatment
- Pressure of voiding, volume of voiding, residual urine after voiding, measured by urine culture and bladder scan at day 14.
研究者
研究点 (1)
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