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 - 25/08/11
Abstract |
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 ⍺ 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.
Le texte complet de cet article est disponible en PDF.Keywords : Prophylaxis, Urinary tract infection, Incontinence
Plan
 | Presented at the Twenty-fourth Annual Meeting of the American Urogynecologic Society, Hollywood, Fla, September 11-13, 2003. This study has been sponsored by an unrestricted educational grant from Proctor and Gamble in the amount of $25,610, and also supported by grant RR 00059 from the National Institutes of Health General Clinic Research Centers Program, Bethesda, Maryland, and supported by General Clinic Research Center grant no. M01 RR 00997 from the National Center for Research Resources. Reprints will not be available. |
Vol 191 - N° 1
P. 182-187 - juillet 2004 Retour au numéro
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