PURPOSE:Antibiotic prophylaxis (low dose chemoprophylaxis) has been prescribed since the introduction of clean intermittent catheterization in children with spina bifida. We hypothesized that stopping low dose chemoprophylaxis does not increase the number of urinary tract infections in these patients. MATERIALS AND METHODS: A total of 176 patients with spina bifida participated in a randomized controlled trial (ISRCTN trial number 56278131) of either continuation or discontinuation of low dose chemoprophylaxis. During the 18-month study period biweekly urine samples were evaluated for leukocyturia and bacteriuria with dipsticks and cultures. Asymptomatic significant bacteriuria (positive culture results without clinical symptoms) and urinary tract infections (significant bacteriuria with clinical symptoms and leukocyturia) were analyzed. RESULTS: Discontinuation of low dose chemoprophylaxis resulted in higher rates of asymptomatic significant bacteriuria (incidence rate ratio 1.23, 95% CI 1.08-1.40, p = 0.002) and urinary tract infection (IRR 1.44, 95% CI 1.13-1.83, p = 0.003). For urinary tract infection the number needed to harm was 2.2, that is if 2 patients discontinued low dose chemoprophylaxis for a year, 1 extra urinary tract infection would result. Febrile urinary tract infection occurred once in every 30 patient-years and slightly more often in the discontinuation group (relative risk 2.0, 95% CI 0.38-10.6, p = 0.4). Of 88 patients allocated to discontinuation of low dose chemoprophylaxis 38 (43%) switched back to chemoprophylaxis. The urinary tract infection rate was nonsignificantly higher in the presence of vesicoureteral reflux. Male gender and a low pre-study rate of urinary tract infection predicted successful discontinuation. CONCLUSIONS:Patients with spina bifida on clean intermittent catheterization and antibiotic prophylaxis for urinary tract infections can safely discontinue this prophylaxis, in particular males, patients with low urinary tract infection rates and patients without vesicoureteral reflux. Copyright Â
RCT Entities:
PURPOSE: Antibiotic prophylaxis (low dose chemoprophylaxis) has been prescribed since the introduction of clean intermittent catheterization in children with spina bifida. We hypothesized that stopping low dose chemoprophylaxis does not increase the number of urinary tract infections in these patients. MATERIALS AND METHODS: A total of 176 patients with spina bifida participated in a randomized controlled trial (ISRCTN trial number 56278131) of either continuation or discontinuation of low dose chemoprophylaxis. During the 18-month study period biweekly urine samples were evaluated for leukocyturia and bacteriuria with dipsticks and cultures. Asymptomatic significant bacteriuria (positive culture results without clinical symptoms) and urinary tract infections (significant bacteriuria with clinical symptoms and leukocyturia) were analyzed. RESULTS: Discontinuation of low dose chemoprophylaxis resulted in higher rates of asymptomatic significant bacteriuria (incidence rate ratio 1.23, 95% CI 1.08-1.40, p = 0.002) and urinary tract infection (IRR 1.44, 95% CI 1.13-1.83, p = 0.003). For urinary tract infection the number needed to harm was 2.2, that is if 2 patients discontinued low dose chemoprophylaxis for a year, 1 extra urinary tract infection would result. Febrile urinary tract infection occurred once in every 30 patient-years and slightly more often in the discontinuation group (relative risk 2.0, 95% CI 0.38-10.6, p = 0.4). Of 88 patients allocated to discontinuation of low dose chemoprophylaxis 38 (43%) switched back to chemoprophylaxis. The urinary tract infection rate was nonsignificantly higher in the presence of vesicoureteral reflux. Male gender and a low pre-study rate of urinary tract infection predicted successful discontinuation. CONCLUSIONS:Patients with spina bifida on clean intermittent catheterization and antibiotic prophylaxis for urinary tract infections can safely discontinue this prophylaxis, in particular males, patients with low urinary tract infection rates and patients without vesicoureteral reflux. Copyright Â
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