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 catheterization.

Author(s): Rogers RG, Kammerer-Doak D, Olsen A, Thompson PK, Walters MD, Lukacz ES, Qualls C

Affiliation(s): University of New Mexico, and Lovelace Medical Center, Albuquerque, NM,University of Iowa, Iowa City, Iowa,Obstetric and Gynecological Associates, Houston, Tex,Cleveland Clinic Foundation, Cleveland, Ohio,and Kaiser Permanente, San Diego, Calif USA.

Publication date & source: 2004-07, Am J Obstet Gynecol., 191(1):182-7.

Publication type: Clinical Trial; Comparative Study ; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, P.H.S.

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 alpha 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 prophylaxis 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.