NCT06843538招募中3 期
Peri-operative Tamsulosin and Impact on Voiding Trial Following Outpatient Urogynecology Surgery: a Randomized Controlled Trial
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Voiding trial on postoperative day 0
研究概览
简要总结
The purpose of this research study is to determine if taking tamsulosin preoperatively decreases your chances of being discharged after surgery with a Foley catheter (flexible tube that drains urine from the bladder into a collection bag).
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing any pelvic organ prolapse repair or incontinence surgery
排除标准
- •Any surgery involving a non-urogynecologist
- •Patients already on an alpha blocker
- •Baseline hypotension
- •History of syncope
- •Postural orthostatic tachycardia syndrome (POTS)
- •Non-English speaker or interpreter unavailable for Spanish-speaking patient
- •Impaired cognition impeding proper consenting
- •Any other medical contraindication for tamsulosin use
- •History of urinary retention requiring continuous or intermittent catheterization
- •Patients consented for the study but then due to intraoperative complication, routine voiding trial no longer indicated due to requiring indwelling catheter or intermittent catheterization on discharge will be excluded from primary outcome analysis
- •Pregnancy
研究组 & 干预措施
Study Arm
Active Comparator
干预措施: Tamsulosin (Drug)
Control Arm
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Voiding trial on postoperative day 0
时间窗: Day of surgery
Whether or not patients pass or fail their postoperative voiding trial
次要结局
- Secondary postoperative urinary retention(2 weeks following surgery)
- Postoperative urinary tract infection(30 days after surgery)
研究者
研究点 (1)
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