Urinary Catheter Self-Discontinuation After Urogynecology Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 118
- 试验地点
- 8
- 主要终点
- Number of Participants With Postoperative Urinary Retention
研究概览
简要总结
The goal of this randomized clinical trial is to determine if removal of transurethral urinary catheters by patients at home is as safe as catheter removal in the office following urogynecologic surgery.
Participants will be randomized to either standard catheter removal in the office or catheter self-removal at home.
详细描述
This is a prospective, randomized, two-parallel arm, non-inferiority trial to evaluate two methods of catheter discontinuation in women with post-operative urinary retention (POUR) after surgery for pelvic organ prolapse (POP) or stress urinary incontinence (SUI). This study will evaluate whether self-discontinuation of transurethral catheter by patients is non-inferior to standard office discontinuation based on rates of persistent POUR on post-operative day (POD) 1.
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
- •Are at least 18 years of age
- •Are fluent and able to read in English or Spanish
- •Undergo POP and/or SUI surgery (uterosacral ligament suspension, sacrospinous ligament fixation, sacral colpopexy, anterior colporrhaphy, posterior colporrhaphy, and/or mid-urethral sling) that occurs on Monday - Thursday
- •Have transurethral catheter in place at the conclusion of surgery as part of standard care
- •Are diagnosed with POUR on POD0 based on ultrasound bladder scan PVR of 100 mL or more
- •Are discharged home on the same day of surgery (POD 0)
排除标准
- •Have preoperative voiding dysfunction requiring self-catheterization or indwelling transurethral catheter
- •Have physical or mental impairment that would impact their ability to remove their catheter themselves.
- •Undergo urethral bulking injections as part of surgery
- •Have undergone a planned or unplanned urinary tract procedure requiring prolonged catheterization as standard of care (e.g. cystotomy repair, ureteral reimplantation, vesicovaginal fistula repair, urethral diverticulum repair)
结局指标
主要结局
Number of Participants With Postoperative Urinary Retention
时间窗: Post-operative day 1
Non-inferiority comparison of the rates of persistent POUR on POD1 between catheter self-discontinuation and standard office catheter. Persistent POUR is defined as PVR greater than 100 mL by bladder scan on POD1.
次要结局
- Rates of postoperative urinary tract infection (UTI)(within 6 weeks of surgery)
- Incidence of recurrent POUR(within 6 weeks of surgery)
- Number of postoperative patient encounters(within 6 weeks of surgery)
- Patient satisfaction assessment via the Acceptability of Intervention Measure (AIM) Questionnaire(Post-operative day 1)
- Patient satisfaction assessment via the the Surgical Satisfaction Questionnaire - 8 (SSQ-8).(Post-operative day 1)