INTRODUCTION AND OBJECTIVES: The main goal of the management of vesicoureteral reflux (VUR) is prevention of recurrent urinary tract infections (UTI) and thereby prevention of renal parenchymal damage possibly ensuing from these infections. Recommendations from the guidelines were that children with VUR could be initially managed medically with continuous antibiotic prophylaxis. However a few recent randomized controlled trials suggest that antibiotic prophylaxis offers no advantage in terms of prevention recurrent UTIs or new renal damage. To compare the incidence of UTI and rate of new renal scars in girls with primary VUR diagnosed after a febrile UTI while they were on prophylactic antibiotics or placebo.

METHODS: Our study was a randomized double-blind controlled trial performed at a university teaching hospital; The inclusion criteria were girls 3 months to 3 years of age with acute pyelonephritis and vesicoureteral reflux (grades I,II and III). Patients were assigned randomly to receive antibiotic prophylaxis (nitrofurantoin 1.5 mg/kg/day) or placebo. Patients were monitored every 2 months for 2 years. Urinalysis and urine culture were performed at each clinic visit and if symptoms of UTI were present. Renal ultrasound was performed every 6 months and Dimercaptosuccinic acid renal scans (DMSA) were repeated every 12 months. Avoiding cystourethrography (VCUG) was performed at the end of the study. The primary end point was recurrence rate of febrile urinary tract infections during 24 months. Secondary end point was the rate of renal scarring produced by recurrent urinary tract infections on DMSA after 24 months.

RESULTS: 107 patients were randomly assigned: 54 to antibiotic prophylaxis (group A) and 53 to the placebo group (group B). Groups were similar with respect to age, and reflux grade. The overall incidence of UTI was 33.6%. Among patients receiving urinary antibiotic prophylaxis the incidence was 35.2% (19 children) and among children receiving placebo was 32.1% (17 children). No statistically significant differences were found among the groups with respect to rate of recurrent UTI (p=0.734). No significant difference was found in the secondary outcome: 2 (3.7%) of 54 patients on prophylaxis versus 3 (5.7%) of 53 patients on placebo.

CONCLUSIONS: Continuous antibiotic prophylaxis was ineffective in reducing the rate of pyelonephritis recurrence and the incidence of new renal scars in girls with vesicoureteral reflux grades I to III.

Source of Funding: none