Prevention of recurrent urinary tract infections in female children

The aim of this randomized, controlled, open-label pilot study was to compare the efficacy and tolerability of long-term immunotherapy (OM-89) with that of nitrofuran chemotherapy (nitrofurantoin) to prevent recurrent urinary tract infections (UTIs) in female children. Of the 40 patients participating in this study (mean age, 6.5 years; range, 2 to 10 years), 22 were randomly assigned to group A (OM-89) and 18 to group B (nitrofurantoin). The study was carried out in three 6-month phases. In phase I (run-in) both groups were given nitrofurantoin 1 mg/kg/d (a standard prophylactic dose); in phase II, group A received one capsule per day of OM-89 (6 mg/d, active compound), and group B continued the nitrofurantoin treatment. Phase III was a follow-up phase without medication. The diagnosis of a bacterial UTI was based on clinical symptoms (dysuria) and positive urine culture (significant bacteriuria and pyuria). The results show that the oral OM-89 treatment elicits a highly significant decrease in UTIs compared with baseline (6-month prestudy data). The efficacy of the long-term administration of OM-89 in this study was comparable to that of nitrofurantoin during phase II (months 6 to 12) and phase III (months 12 to 18). OM-89 can be considered as an alternative to chemotherapeutic prophylaxis; OM-89 is well tolerated and effective in decreasing the incidence of UTIs in female children prone to recurrences.