Prophylactic Antibiotics for Outpatient Urethral Bulking: Impact on Post-Procedural Urinary Tract Infection Rates
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Incidence of post-procedural urinary tract infection (UTI) within six weeks following urethral bulking procedure
研究概览
简要总结
The purpose of this study is to evaluate whether taking prophylactic (preventative) antibiotics at the time of standard of care clinic-based urethral bulking reduces the risk of post-procedural urinary tract infection (UTI).
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
- •Women ≥ 18 years of age.
- •Patients evaluated by a pelvic floor specialist (either urogynecologist or urologist) at the University of Miami with plans to undergo urethral bulking with Bulkamid for stress urinary incontinence or mixed urinary incontinence (stress predominant).
- •Negative testing for UTI in pre-procedural work-up, including either negative urine culture or urine dip negative for infection (infection is defined as the presence of nitrites and/or pyuria with >1+ leukocyte esterase on dipstick or >5 WBC/HPF).
- •Post-void residual volume of 150 mL or less (measured by either catheterization or bladder scan) before the procedure
- •Fluent in English or Spanish
- •Able and willing to provide informed consent
排除标准
- •Contraindications to both oral antibiotics including antibiotic allergies or significant renal disease (GFR <30)
- •Patient undergoing additional pelvic organ prolapse procedures or other urologic procedures concomitantly that also involve insertion [KB2.1]of a foreign object
- •Recurrent UTIs, defined as 3 or more UTIs within the past 12 months or 2 UTIs within the past 6 months
- •Patients currently taking daily antibiotic prophylaxis for any reason
- •Patients with immunosuppression due to underlying medical conditions
- •Patients who are pregnant
- •Recent antibiotic treatment within one week of the procedure
- •Unable or unwilling to provide informed consent or complete study procedures
研究组 & 干预措施
Prophylactic Antibiotic Group
Participants in this group will receive a single oral dose of either Bactrim (800 mg sulfamethoxazole + 160 mg trimethoprim), Keflex (500 mg cephalexin), Cipro (250 mg ciprofloxacin), or if allergic to sulfonamides, a single oral dose of Macrobid (100 mg nitrofurantoin) at the time of standard of care clinic-based urethral bulking procedure.
干预措施: Bactrim (800/160 mg), Keflex (500 mg), Cipro (250 mg), or Macrobid (100mg) (Drug)
No Prophylactic Antibiotic Group
Participants in this group will not receive prophylactic antibiotics at the time of standard of care clinic based urethral bulking procedure.
结局指标
主要结局
Incidence of post-procedural urinary tract infection (UTI) within six weeks following urethral bulking procedure
时间窗: 6 Weeks
The occurrence of urinary tract infection (UTI) within 6 weeks post-procedure will be compared between patients who receive prophylactic oral antibiotics administered in clinic at the time of urethral bulking and those who do not receive antibiotic prophylaxis. UTI will be defined by clinical diagnosis documented in the medical record, with or without supporting urine culture results.
次要结局
未报告次要终点
研究者
Katherine Amin
Assistant Professor of Clinical Urology
University of Miami