Timing of Active Void Trials After Urogynecologic Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 231
- 试验地点
- 1
- 主要终点
- Pass Rate
研究概览
简要总结
The goal of this clinical trial is to learn about active void trial pass rates in patients undergoing urogynecologic surgery. The main question it aims to answer is the comparison in pass rate during active void trial between women who are given 30 minutes versus 60 minutes to void following urogynecologic surgery.
Patient will be randomized to two arms prior to scheduled surgery. During the active void trial, women will be allotted up to 30 minutes or up to 60 minutes to void depending on respective randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Women undergoing a urogynecologic surgery at Tampa General Hospital and who are seen preoperatively at the University of South Florid Urogynecology clinic
- •Women undergoing a urogynecologic surgery where a postoperative active void trial is indicated
- •Planned for same day surgery
- •Women able to consent for themselves
- •Speak English and/or Spanish as preferred language
排除标准
- •Imprisoned patients
- •Females under the age of 18 years old
- •Women who are unable or unwilling to consent to participation
- •Women who are planning to stay inpatient overnight
- •Women with history of urinary retention or neurogenic bladder
- •Women undergoing procedure that is not standard of care to perform a void trial (includes sacral neuromodulation, botox to the pelvic floor, cystoscopy with hydrodistension, urethral bulking, etc)
研究组 & 干预措施
Immediate
Patients will be given up to 30 minutes to void during the active void trial postoperatively.
干预措施: Time (Other)
Extended
Patients will be given up to 60 minutes to void during the active void trial postoperatively.
干预措施: Time (Other)
结局指标
主要结局
Pass Rate
时间窗: 60 minutes
to compare the active void trial pass rate between arms
次要结局
- Time in PACU(6 hours)
- Pass Rate After Failing(60 minutes)
- UTI(2 weeks)
- Surgical Procedures Performed Prior to Active Void Trial(2 years)
研究者
Simone Fertel
Primary Investigator
University of South Florida