A randomized, double-blind, placebo-controlled comparison of the effect of nitrofurantoin monohydrate macrocrystals on the development of urinary tract infections after surgery for pelvic organ prolapse and/or stress urinary incontinence with suprapubic c

Objective The purpose of this study was to determine if antibiotic prophylaxis with nitrofurantoin monohydrate macrocrystals (study drug) after pelvic organ prolapse and/or urinary incontinence surgery with suprapubic catheterization (SPC) decreases urinary tract infection (UTI) compared with placebo in a randomized, double-blind, multicenter trial. Study design Six centers participated in this study. After a negative preoperative urine culture, history, surgical and postoperative course, urine culture and symptoms at SPC removal, and at 6 to 8 weeks postoperative, any other UTI and adherence were recorded. To demonstrate a 50% decrease in the bacteruria rate from 20%, with 80% power and α of 0.05, 438 patients were required. Data were evaluated with Student t test and Fisher exact test. Results Of 449 patients enrolled, 211 randomized to study drug, and 224 randomized to placebo. No pre- or perioperative differences existed between groups (all P > .05). Antibiotic prophylaxis decreased positive urine cultures compared with placebo (46% vs 61%, P = .002), symptomatic UTI at SPC removal (7.2% vs 19.8%, P = .001), and any other symptomatic UTI 6 to 8 weeks postoperatively (18.9% vs 32.6%, P = .002). Antibiotic prophlylaxis did not decrease symptomatic UTI at the 6- to 8-week postoperative visit (1.8% vs 5.4%, P = .10). Conclusion Antibiotic prophylaxis with nitrofurantoin monohydrate macrocrystals decreases UTI compared with placebo after pelvic organ prolapse and/or urinary incontinence surgery with suprapubic catheterization.