Nitrofurantoin Administration for the Prevention of Short-Term Catheter Associated Urinary Tract Infection After Pelvic Surgery

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Atrium Health; Carolinas Healthcare System
• Treatments: Nitrofurantoin

Criteria

Inclusion Criteria:

• Age greater than 18

• Creatinine clearance greater than 30 ml/min

• Failed postoperative hospital voiding trial

Exclusion Criteria:

• Pregnant

• 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