Gentamicin Intravesical Efficacy for Infection of Urinary Tract
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 370
- 试验地点
- 2
- 主要终点
- Post-operative Urinary Tract Infection
研究概览
简要总结
Urinary tract infection (UTI) is a common problem after surgery for pelvic organ prolapse and stress urinary incontinence. This prospective, randomized, single-masked (subject), two-parallel armed study aims to determine the effect of a single postoperative intravesical instillation of 80 mg of gentamicin sulfate in 50 mL of saline versus usual care on the proportion of women treated for UTI within 6 weeks following surgery for pelvic organ prolapse (POP) or stress urinary incontinence (SUI).
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
- Single (Participant)
盲法说明
The subject will be masked as to whether she has been assigned to the gentamicin arm or the control arm. The subject will be unmasked at the completion of the 6 week follow up period.
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
- •Adult women undergoing pelvic organ prolapse surgery and/or stress urinary incontinence surgery with surgical plan for at least 1 cystoscopy and will leave the operating room with a standard-of-care transurethral catheter.
- •Negative urine culture within 4 weeks or completion of UTI treatment ≥48 hours prior to surgery
排除标准
- •History of allergic reaction or anaphylaxis to gentamicin sulfate or to sodium metabisulfite (one of the preservatives in the gentamicin sulfate product)
- •Abnormal intraoperative urinary tract finding (e.g. bladder mass, stone, or fistula)
- •Intraoperative urinary tract injury
- •Suppressive recurrent UTI treatment
- •Chronic indwelling catheter/self-catheterization
- •Unable to provide informed consent
- •Severe renal impairment - glomerular filtration rate of less than 30 mL / minute
- •Current pregnancy
- •Currently incarcerated
研究组 & 干预措施
Gentamicin Arm
At the completion of the subjects surgery but prior to awakening from anesthesia, 80mg of gentamicin in 50 mL of normal saline will be infused into the subject's bladder through the standard-of-care transurethral catheter by the surgeon. The surgeon will then clamp the catheter and label the catheter with the clamping time. The catheter will be clamped to prevent the gentamicin from immediately flowing out of the bladder and thus allow the gentamicin time to have an effect. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care.
干预措施: gentamicin sulfate (Drug)
Control Arm
If the patient is randomized to no instillation, at the end of the surgery but prior to awakening from anesthesia, the surgeon will clamp the catheter and label the catheter with the clamping time. The purpose of clamping the catheter for subjects receiving usual care will be to ensure patients are masked to study arm assignment if they wake up and notice their catheter. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care.
干预措施: Catheter clamping only (Other)
结局指标
主要结局
Post-operative Urinary Tract Infection
时间窗: Within 6 weeks after surgery
Number of participants in each arm treated with antibiotics for urinary tract infection symptoms
次要结局
- Number of Participants With Isolated Uropathogen on Post-operative Urine Culture(Within 6 weeks after surgery)
- Adverse Events(Within 6 weeks after surgery)