NCT04859660已完成2 期
Pre-operative Tamsulosin After Minimally Invasive Hysterectomy and Time to Spontaneous Void: A Randomized Controlled Trial
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
- 161
- 试验地点
- 2
- 主要终点
- Time to Spontaneous Void
研究概览
简要总结
The aim of this study is to determine if a one time dose of tamsulosin given pre-operatively decreases the time to void and the time to discharge after minimally invasive hysterectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18-80 undergoing outpatient minimally invasive hysterectomy
排除标准
- •Inability to provide informed consent
- •Bladder malignancy
- •Intra-operative bladder or ureteral injury; anticipated prolonged bladder catheterization
- •Plan for sling or anterior repair
研究组 & 干预措施
Tamsulosin- intervention group
Experimental
干预措施: Tamsulosin (Drug)
Placebo group
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Spontaneous Void
时间窗: 8 weeks
Each participant underwent a void trial post-operatively by backfilling their bladder with 200cc normal saline at the conclusion of the case and removing the foley. Patients needed to void at least 100cc to be considered to have "passed" their void trial.
次要结局
- Time to Discharge From the Post-anesthesia Care Unit(8 weeks)
研究者
研究点 (2)
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