Patient Removal of Urinary Catheters After Urogynecologic Surgery: A Randomized Non-Inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Risk of Urinary Retention in the Early Postoperative Period
研究概览
简要总结
Management of postoperative urinary retention often requires the use of indwelling catheters. The purpose of this study is to see if patient removal of catheters at home is non-inferior to standard office removal.
详细描述
Voiding trials are a routine part of Urogynecologic surgery. Management of postoperative urinary retention often requires the use of indwelling catheters. However, patients often view the need for catheters as the worst part of their surgical experience, and follow-up voiding trials in the office utilize excess healthcare resources. Many Urology practices allow patient removal of catheters after procedures, though this has not been formally studied. The purpose of this study is to see if patient removal of catheters at home is non-inferior to standard office removal.
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
- 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
- 是
入选标准
- •All women undergoing prolapse or anti-incontinence surgery who fail their voiding trials prior to discharge
- •18+ years old
排除标准
- •Non-English speaking
- •Elevated PVR (>150 mL) or dependent upon catheterization to void pre-operatively
- •Urethral bulking injection surgery
- •Intra-operative complication requiring prolonged catheterization
- •Unable or unwilling to remove catheter at home
结局指标
主要结局
Risk of Urinary Retention in the Early Postoperative Period
时间窗: 2-5 days postoperatively
The percentage of patients who have urinary retention in the early postoperative period (failed voiding trial after discharge POD 2-5) will be measured.
次要结局
- Number of nursing calls and office visits for urinary issues in the six week postoperative period(6 week postoperative period)