Tamsulosin to Facilitate Early Catheter Removal After Urinary Retention in Older Women Hospitalized for an Acute Medical Condition
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- early catheter removal failure
研究概览
简要总结
Catheter-associated urinary infections are the most common hospital-acquired infections and can be prevented by early catheter removal. This study evaluates tamsulosin to reduce the failure of early catheter removal has been studied in elderly women hospitalized for an acute condition and experiencing acute urinary retention: 448 women 75-year old or more without an anatomical or neurological cause of urinary retention will be randomized to a 6 days course of tamsulosin 0.4 mg or placebo. Catheter removal will be attempted after the third dose of tamsulosin and the need to replace another catheter within 72 hours will define a failed attempt.
详细描述
Background: Urinary tract infections are the most frequent hospital-acquired infections. A majority is catheter-associated and the main risk factor is the duration of catheterization. Early removal is therefore a priority. Treatment with alpha-blockers in men with acute urinary retention due to prostatic disease increases the rate of successful early catheter removal. No intervention has been studied in elderly women in whom urinary retention is usually favored by an acute health issue. However, alpha-blockers have proved effective in other circumstances, as the prevention of acute urinary retention after hysterectomy and the treatment of chronic voiding disorders.
Objective: To evaluate the benefit of tamsulosin for 6 days in older women hospitalized for an acute medical condition and experiencing urinary retention.
Primary endpoint: Rate of failed early catheter removal (day 3), requiring placement of another catheter within the following 72 hours.
Secondary endpoints: rate of hospital-acquired urinary tract infections, rate of hypotension, length of hospitalization.
Design: Double-blind and multicentric randomized controlled trial (tamsulosin 0.4 mg/day or placebo orally for 6 days).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •75-year or older women hospitalized in an internal medicine or geriatric ward and with a bladder catheter for less than 48 hours for acute urinary retention.
排除标准
- •chronic urinary retention;
- •acute retention with an anatomical (pelvic tumor, pelvic surgery) or neurological cause (peripheral neuropathy, spinal cord compression, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease);
- •catheter placed for another indication (pressure ulcer protection, urine output monitoring);
- •patient at the end of life;
- •contra-indication to alpha-blockers.
研究组 & 干预措施
tamsulosin
Tamsulosin (0.4 mg/j) (1 tablet / day for 6 days)
干预措施: Tamsulosin (0.4 mg/j) (Drug)
placebo
1 tablet / day for 6 days
干预措施: Placebo (Drug)
结局指标
主要结局
early catheter removal failure
时间窗: between days 3 and 6
need to replace a catheter within 72h following day 3 catheter removal
次要结局
- orthostatic hypotension(days 1 to 6)
- hospital-acquired urinary tract infection(between days 1 and 12)
- length of hospitalization(from day 1)