Optimal Duration of Indwelling Urethral Foley Catheter Following Bulbar Urethroplasty: A Pragmatic Multi-Institutional Randomized Controlled Non-Inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Number of Participants who Experience a Stricture Recurrence
研究概览
简要总结
The goal of this clinical trial is to learn when is the best time to remove a Foley catheter (tube used to drain urine from the bladder) after surgery in adult men who have a specific type of urethral stricture disease (narrowing of the tube that carries urine from the body). The main question it aims to answer is:
- Is there a difference between removing the catheter at 7-10 days versus 18-21 days?
Researchers will compare Foley removal at 7-10 days to removal at 18-21 days to see if there is a difference in problems after surgery or if the narrowing returns.
Participants will:
- Complete a survey before surgery, when the catheter is removed, and within 12 months after surgery
- Complete follow-up visits after surgery based on your specific medical needs and standard of care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Cis-male patients
- •Age 18-70, inclusive
- •Bulbar urethral stricture undergoing a urethroplasty
- •Urethral stricture defect less than or equal to 7cm in length
- •First time urethroplasty
- •Negative urine analysis or urine culture
排除标准
- •History of pelvic radiation
- •Diabetes with Hba1c greater than 8%
- •Penile urethral stricture
- •Posterior urethroplasty
- •Bulbar stricture greater than 7cm
结局指标
主要结局
Number of Participants who Experience a Stricture Recurrence
时间窗: 1 year
Number of Participants who Experience a Perioperative Complication
时间窗: From Foley insertion to Foley removal
次要结局
- Rate of Retrograde Urethrograms Performed on Day of Foley Removal(Foley Removal)
研究者
Jane Kurtzman
Assistant Professor
University of Utah