Foley Catheter vs a Self-contained Valved Urinary Catheter for Patients Who Are Being Discharged Home With a Catheter After Urogynecologic Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of urinary tract infections
研究概览
简要总结
The purpose of this study is to compare UTI rates and patient satisfaction associated with indwelling Foley catheter verses a valved catheter in patients who are being discharged home with a catheter after urogynecologic procedures via a Randomized Clinical Trial.
详细描述
The purpose of this study is to compare UTI rates and patient satisfaction associated with indwelling Foley catheter verses a valved catheter in patients who are being discharged home with a catheter after urogynecologic procedures via a Randomized Clinical Trial. Total number of participants will be 100. Inclusion criteria is all patients undergoing pelvic reconstructive surgery/anti-incontinence procedures who are planned to be discharged home with a catheter. Exclusion criteria is intra-operative bladder injury during index surgery; intra-operative complication requiring continuous bladder drainage; and/or dementia/altered cognitive function.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing pelvic reconstructive surgery/anti-incontinence procedures who are planned to be discharged home with a catheter.
排除标准
- •Intra-operative bladder injury during index surgery
- •Intra-operative complication requiring continuous bladder drainage
- •Dementia / altered cognitive function
结局指标
主要结局
Number of urinary tract infections
时间窗: Up to 4 weeks after surgery
Number of urine cultures positive for infection (taken at voiding trial visit and post-operative visit).
次要结局
- Patient satisfaction(Up to 5 days after surgery)
- Number of days until spontaneous void/Number of calls for device-related issues(Up to 4 weeks after surgery)
研究者
charbel salamon
Charbel Salamon, MD, MS, FACOG
Atlantic Health System