Assessing the Utility of Prophylactic Antibiotics at Time of Urethral Bulking Using Bulkamid
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Risk of post operative urinary tract infections (UTI)
研究概览
简要总结
The primary aim of this study is to assess the utility of prophylactic oral antibiotics at time of Bulkamid transurethral bulking to reduce the incidence of urinary tract infection (UTI) in the immediate postoperative period. The secondary aims of the study include assessing UTI rates and success rates if patients require temporary indwelling catheter versus intermittent self-catheterization (ISC).
详细描述
Specific Aim 1: To determine if receiving prophylactic oral antibiotics at time of urethral bulking reduces the risk of post-operative urinary tract infection (UTI).
Patients will be randomized and blinded into two arms: oral antibiotic versus placebo. Patients will receive either the placebo pill or oral antibiotic in the pre-operative holding area prior to their procedure. Oral antibiotics will include trimethoprim/sulfamethoxazole (Bactrim, first line) or nitrofurantoin (Macrobid, second line), determined by patient allergies.
Specific Aim 2: To assess if factors such as patient discharge with ISC/indwelling foley or number of Bulkamid injection sites is correlated to improvement in Stress urinary incontinence (SUI) at 6 weeks postoperatively and at one year postoperatively.
Patients will complete a brief survey preoperative, at 6 weeks postoperatively after their procedure, and at 1 year postoperatively after their procedure. The survey will consist of prior validated urogynecologic surveys including the Pelvic Floor Disability Index/Urinary Distress Inventory (PFDI/UDI- 6) and the MESA questionnaires as well as an extended VAS scale to evaluate global improvement.
Specific Aim 3: To discern if any patient characteristics are associated with higher patient satisfaction following the procedure.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Neither participants, providers, investigators or outcome assessors will know to which of these groups participants are assigned. In case of an emergency, however, the study doctor can get this information.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Identical appearing placebo for a single dose
干预措施: Placebo (Drug)
Bactrim or Macrobid (single dose)
Bactrim (800/160mg) or Macrobid (100 mg) depending on participants' allergies
干预措施: Bactrim or Macrobid (Drug)
结局指标
主要结局
Risk of post operative urinary tract infections (UTI)
时间窗: 6 weeks after the procedure
Intervention (pre-operative oral antibiotics) and placebo groups will be compared for the risk of post-operative UTIs following urethral bulking procedures performed in the operating room. Patients who have symptoms, concerning for UTI during the immediate 6 week postoperative period will be asked to give a urine sample for culture. UTIs which are culture proven and symptomatic will be treated per individual provider preference. Positive urine cultures will be defined as cultures with greater than 50,000 CFU for voided specimens and greater than 5,000 CFU for catheter specimens. If a patient's urine culture is positive for mixed flora and cannot be speciated further by our microbiology laboratory, they will be asked to present for a straight catheter specimen in the office for definitive diagnosis; this is an established protocol which is already standard in our practice. All positive cultures during this time period will be recorded.
次要结局
- Drug Use and Side Effects(6 weeks and 1 year after the procedure, up to 1 year)
- Effects on higher patient satisfaction(6 weeks and 1 year after the procedure, up to 1 year)
研究者
Susanne Taege
MD, Assistant Professor
Ohio State University