Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Number of Participants With a Positive Urinary Tract Infection
研究概览
简要总结
The aim of this study is to determine whether antibiotics prophylaxis at the time of urinary catheter removal decreases the number of symptomatic urinary tract infections in patients after radical prostatectomy. In addition, the investigators aim to determine whether antibiotic prophylaxis is potentially harmful to patients (e.g. adverse reactions from antibiotic use, resistant bacteria in the urine, Clostridium difficile infections etc.). The investigators also aim to identify specific populations that may be at higher risk of developing urinary tract infections with urinary catheter use after radical prostatectomy.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects will include patients undergoing radical prostatectomy for prostate cancer. Subjects will be randomized into control or treatment group.
排除标准
- •Subjects with a history of adverse reaction to ciprofloxacin, or any other quinolone will be excluded. Subjects being treated with tizanidine or with a history of myasthenia gravis will be excluded. In addition, we will exclude patients with major immediate post-operative complications after prostatectomy including significant post-operative bleeding with known pelvic hematoma and known urine leak.
研究组 & 干预措施
Ciprofloxacin
Antibiotic
干预措施: Ciprofloxacin (Drug)
结局指标
主要结局
Number of Participants With a Positive Urinary Tract Infection
时间窗: 12 months
After removal of the catheter, urine was tested for infection whenever symptoms were experienced by the participants from the time they enrolled to 12 months following their operation.
次要结局
- Number of Participants Positive for Clostridium Difficile(3 months)
- Number of Participants With Bacteria in Urine(3 months)
研究者
Jean Joseph
Professor of Urology and Oncology
University of Rochester