Early Patient Removal of Urinary Catheters After Urogynecologic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Number of patients with ongoing urinary retention (noninferiority)
研究概览
简要总结
Management of postoperative urinary retention often requires the use of indwelling catheters. In a previous study, the investigators determined that patient removal of catheters at home is non-inferior to standard office removal on postoperative day three or four (POD3-4). The purpose of this study is to determine whether patient removal of catheters at home on postoperative day one (POD1) is noninferior to removal on POD 3-4.
详细描述
Randomized, controlled, non-inferiority trial to compare the risk of urinary retention between patient urinary catheter removal on POD1 versus POD3-4 after urogynecologic surgery.
Aim One: Is the risk of urinary retention non-inferior with patient removal of transurethral catheters on POD1 versus POD3-4 after urogynecologic surgery?
Aim Two: Does healthcare resource utilization (nursing calls, patient messages, and office visits) differ between patient removal of transurethral catheters on POD1 versus POD3-4?
Aim Three: Does the patient experience differ between patient removal of transurethral catheters on POD1 versus POD3-4?
Aim Four: Does the incidence of postoperative UTI differ between patient removal of transurethral catheters on POD1 versus POD3-4?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（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.
排除标准
- •Non-English speaking (due to limited resources to consent non-English speaking patients)
- •Postvoid residual (PVR) >150 mL or dependent upon catheterization to void pre-operatively
- •Intra-operative complication requiring prolonged catheterization
研究组 & 干预措施
Early Catheter Removal
Participants in this arm will be asked to remove their catheters POD1.
干预措施: Early catheter removal (Procedure)
Standard Catheter Removal
Participants in this arm will be asked to remove their catheters POD3-4.
结局指标
主要结局
Number of patients with ongoing urinary retention (noninferiority)
时间窗: From Postoperative day 1 through postoperative week 8
Defined as need for catheter replacement or clean intermittent self catheterization (CISC) after catheter removal on POD1 vs POD3-4. A 95% confidence interval of the difference in proportions between the two groups will be used to assess the tenability of a non-inferiority proposition.
次要结局
- Number of patients treated for postoperative UTI.(From Postoperative day 1 through postoperative week 8)
- Number of patient contacts for voiding dysfunction by Type(From Postoperative day 1 through postoperative week 8)
- Patient Satisfaction Survey Score-Satisfaction(Postoperative week 2)
- Patient Satisfaction Survey Score-Pain(Postoperative week 2)
- Patient Satisfaction Survey Score-Ease of Use(Postoperative week 2)
- Total patient contacts for voiding dysfunction Combined(From Postoperative day 1 through postoperative week 8)
- Number of patients with ongoing urinary retention(From Postoperative day 1 through postoperative week 8)
- Patient Satisfaction Survey Score-Likelihood to Use Again(Postoperative week 2)