Nitrofurantoin Prophylaxis During Catheter-managed Acute Urinary Retention After Pelvic Reconstructive Surgery
Status:
Completed
Trial end date:
2018-05-12
Target enrollment:
Participant gender:
Summary
The specific aim of this randomized double-blind placebo-controlled trial is to determine if
extended release nitrofurantoin antibiotic prophylaxis decreases the incidence of symptomatic
urinary tract infection (UTI) compared with placebo for patients undergoing short term
indwelling or clean intermittent self-catheterization (CISC) for acute postoperative urinary
retention following pelvic organ prolapse and/or urinary incontinence surgery.
Consented patients who undergo urogenital surgery and fail their post-operative voiding trial
will be randomized to either extended release nitrofurantoin 100mg or an identical appearing
placebo capsule to be taken daily while performing CISC or while indwelling catheter is in
place. The primary outcome will be symptomatic and culture confirmed UTI within six weeks of
surgery. Secondary outcomes include adverse events associated with nitrofurantoin use, and
incidence of nitrofurantoin-resistant isolates from urine culture of symptomatic women.
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 33% to 13%, with 80% power, and a two-sided alpha of 0.05,
and a 10% dropout rate, we should recruit a total of 154 patients.