NCT03524339已完成2 期
Perioperative Administration of Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Postoperative Urinary Retention
研究概览
简要总结
This is a placebo controlled randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients must be 18 years or older as well as willing and able to provide informed consent
- •Patients must be undergoing a scheduled surgery for pelvic organ prolapse or urinary incontinence
- •Standard postoperative plan must include admission to the hospital with foley catheterization overnight the night after surgery, and planned removal of foley catheter and active voiding trial on postoperative day 1.
排除标准
- •Patient unable or unwilling to provide informed consent
- •Severe allergy to sulfa drugs
- •Known allergy to tamsulosin or another alpha antagonist medication
- •History of urinary retention
- •Planned bladder catheterization greater than 24 hours after surgery
- •Current use of alpha antagonist medication for hypertension
- •End stage renal or liver disease
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo oral capsule (Drug)
Tamsulosin
Experimental
干预措施: Tamsulosin (Drug)
结局指标
主要结局
Postoperative Urinary Retention
时间窗: Within 72 hours of surgery
Failed voiding trial upon removal of catheter
次要结局
- Sent Home With Catheterization(within 6 weeks of surgery)
- Postoperative Urinary Tract Infection(Within 6 weeks after surgery)
- International Prostate Symptom Score(Within 1 week of surgery)
研究者
Graham Chapman
Principal Investigator
University Hospitals Cleveland Medical Center
研究点 (2)
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