Nitrofurantoin Prophylaxis Following Short-Term Transurethral Catheterization: A Randomized Controlled Trial

Abstract

Study Objective To evaluate if nitrofurantoin prophylaxis following discontinuation of transurethral catheterization decreases the rate of urinary tract infection. Design Double-blind, Placebo controlled, Randomized trial. Setting Academic. Patients or Participants Women with postoperative urinary retention following pelvic reconstructive surgery managed with transurethral catheterization. Interventions Twice daily dosing of nitrofurantoin or placebo for five days following transurethral catheter removal. Measurements and Main Results This trial was conducted across two clinical sites between October 2017 and April 2019. Once participants passed the postoperative in-office voiding trial, they were randomized to receive oral nitrofurantoin 100mg or placebo twice daily for five days and keep a medication diary to evaluate medication compliance. The primary outcome was clinically suspected urinary tract infection (defined as dysuria, frequency, and irritation in the absence of vaginal discharge) and/or culture-proven urinary tract infection (defined as greater than 105 colony forming units of a single organism) within 30 days of surgery. Secondary outcomes included evaluation of adverse events related to study medication and study medication compliance. Data from 164 consented participants were eligible for analysis (nitrofurantoin, n=82; placebo, n=82). There were no significant demographic and intraoperative differences between groups except for body mass index (27.1±4.7 vs 28.6±5.0 kg/m2, p=0.05) and race ([96.3% vs 87.8% Caucasian, p=0.04] vs [1.2% vs 9.8%, p=0.03]). Median duration of postoperative transurethral catheterization was 3 days (IQR 2-5 days, p=0.12). Fifteen women in the nitrofurantoin group and 14 women in the placebo group experienced urinary tract infections within 30 days (18.3% vs 17.1%, p=0.84, odds ratio [95% CI] 1.09 [0.49-2.43]). There were no study medication allergies, however, nausea was the most common intolerance. Most women in each group completed the study drug treatment (91.5% vs 86.4%, p=0.30). Conclusion Nitrofurantoin prophylaxis following removal of the transurethral catheter did not reduce risk of urinary tract infection in women with postoperative urinary retention following pelvic reconstructive surgery.