Nitrofurantoin Administration for the Prevention of Short-Term Catheter Associated Urinary Tract Infection After Pelvic Surgery (NAUTICA): A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- UTI
研究概览
简要总结
The specific aim of this randomized double-blind placebo-controlled trial is to evaluate the efficacy of administration of nitrofurantoin prophylaxis after catheter discontinuation for the prevention of catheter-associated urinary tract infections in patients with postoperative short-term catheterization following pelvic reconstructive surgery and/or urinary incontinence surgery.
Patients that undergo pelvic organ prolapse and/or urinary incontinence surgery and fail their post-operative voiding trial will be included in the study. Upon successfully passing and in-office voiding trial at the time of catheter removal, they will be randomized to either nitrofurantoin 100mg twice daily or an identical appearing placebo capsule twice daily for 5 days following catheter removal. The primary outcome will be the treatment of clinically suspected and/or culture-proven UTI within 30 days of surgery. Secondary outcomes include adverse events associated with nitrofurantoin use and medication compliance.
Primary and secondary outcomes will be evaluated with Student t test and chi squared or Fisher exact test as appropriate. Assuming a decrease in symptomatic UTIs attributable to nitrofurantoin prophylaxis from 32% to 14%, with 80% power, and a two-sided alpha of 0.05, we should recruit a total of 164 patients.
详细描述
Urinary tract infections (UTI) are the most common hospital-acquired infections, accounting for nearly 30% of cases of nosocomial infections and affecting nearly 1 million people per year.
Following pelvic reconstructive and urinary incontinence surgery, UTIs are one of the most common complications with a risk between 8.9%-34%. The baseline risk of UTI associated with pelvic floor surgery ranges between 5-35%, increasing greatly with catheterization.
Postoperative voiding dysfunction and incomplete bladder emptying is common following pelvic reconstructive and incontinence surgeries, with incidence ranging from 2.5 % to 31%. As a result, these women may have additional catheterization for a short period of time, which increases the risk of UTI. There is a 15-20% risk of developing a postoperative UTI with short-term catheterization, even if the catheter remains in place for merely 24 hours. The risk of UTI increases 5-10% each day the catheter is left in place.
Numerous studies have been conducted to evaluate different prophylactic antibiotic regimens to help decrease the rate of postoperative catheter-associated UTIs. Many of these studies have shown precedent for the use of antibiotic prophylaxis.
Nitrofurantoin has been evaluated as a prophylactic regimen for use during short-term catheterization. These studies had favorable results, decreasing the incidence of UTI postoperatively.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age greater than 18
- •Creatinine clearance greater than 30 ml/min
- •Failed postoperative hospital voiding trial
排除标准
- •History of glucose-6-phosphate dehydrogenase deficiency
- •History of renal insufficiency, renal transplant, or nephropathy
- •Allergy to nitrofurantoin
- •History of recurrent UTI (defined as greater than two culture-proven infections in six months or three infections in one year)
- •Urinary Tract Infection (UTI) within 14 days one month of surgery
- •Non-English speaking
- •Urinary tract infection while Foley catheter is in place
- •On antibiotic therapy for other non-urological reasons
- •Sustained intraoperative bladder injury requiring prolonged catheterization greater than 5 days
- •Undergoing mesh excision from within the bladder, fistula repair, cystotomy repair, urethral diverticulectomy, sacral neuromodulation, urethral surgery, or any other procedure requiring prolonged catheterization and bladder decompression
- •Placement of a suprapubic catheter
- •Participants that request intermittent self-catheterization
- •Neurologic conditions affecting urinary tract system and normal voiding mechanisms
- •History of hepatic impairment due to prior nitrofurantoin use
- •Inability to provide consent/decisionally impaired
- •More than two in-office voiding trials
研究组 & 干预措施
Nitrofurantoin
Receives twice daily 100mg nitrofurantoin for 5 days following catheter removal
干预措施: Nitrofurantoin 100 MG (Drug)
Placebo
Receives twice daily matching placebo for 5 days following catheter removal
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
UTI
时间窗: within 30 days of surgery
Number of participants with a urinary tract infection in the first 30 days following pelvic reconstructive surgery
次要结局
- Medication Compliance(within 30 days of surgery)
- Adverse Events(within 30 days of surgery)