The Effectiveness of Prophylactic Antibiotics for Urethral Bulking
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Rate of urinary tract infection (UTI)
研究概览
简要总结
The goal of this clinical trial is to evaluate if prophylactic antibiotics in urethral bulking are effective in reducing postprocedural urinary tract infections.
详细描述
Urethral bulking is a minimally invasive surgical treatment option for stress urinary incontinence (SUI). One commonly reported post-procedural complication is urinary tract infection (UTI). UTI rates are variable where studies have reported rates from as low as 0% to as high as 40%. Along with this variability, the instructional inserts for various bulking agents have inconsistent recommendations for use of prophylactic antibiotics. The American Urologic Association recommends antimicrobial prophylaxis for cystourethroscopy procedures involving minor manipulation. Currently, there are no clear guidelines regarding the utility of prophylactic antibiotics for urethral bulking. The objective of our study is to determine the effectiveness of prophylactic antibiotics in urethral bulking for reducing post procedural UTIs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients scheduled to undergo a urethral bulking procedure
- •Age 18 ≥ over
排除标准
- •History of recurrent urinary tract infections
- •Known history of urinary retention
- •Allergies or contraindications to multiple antibiotics
- •Inability to tolerate oral antibiotics
- •Concomitant surgical procedures at the time of urethral bulking
- •Pregnant or breastfeeding
研究组 & 干预措施
Antibiotic Group
Those randomized to this group will receive a one-time dose of an oral antibiotic prior to the urethral bulking procedure. The antibiotic will be based on the participants' allergies, medical history, and current medication list.
干预措施: Prophylactic antibiotics (Other)
结局指标
主要结局
Rate of urinary tract infection (UTI)
时间窗: Within 4 weeks after the procedure
The rate of UTI based on symptoms and a positive urine culture
次要结局
- Rates of other postoperative complications(Within 4 weeks after the procedure)
- Rate of postoperative urinary retention(Within 4 weeks after the procedure)
研究者
Erika Wasenda
MD
Atlantic Health System