Purpose: We wanted to investigate the efficacy and safety of the immunotherapeutic Uro-Vaxom for treating uncomplicated recurrent cystitis in female patients only. Materials and Methods: Adult female patients were enrolled in this multicenter, open-label study if they had acute cystitis at the enrollment visit and positive results on urine culture (≥103 CFU/ml). The patients were treated for 3 months with one capsule daily of Uro-Vaxom after antibiotic therapy, and they were observed for another 3 months. The primary efficacy criteria were the cystitis recurrence rates over 6 months, the distribution of cystitis and the proportion of patients with cystitis. Results: A total of 50 patients were evaluated. During the 6-month trial, the number of cystitis recurrences was significantly reduced in comparison with the 6-month pretrial period (on the average 0.64 as compared to 3.0 recurrences, respectively p < 0.001). The incidences of frequency, urgency and dysuria remained low until the end of the trial. Uro-Vaxom was well tolerated: side-effects were mentioned by 8% of the 50 patients, and there was no case leading to treatment withdrawal. Conclusions: Uro-Vaxom significantly reduced the incidence of cystitis during the 6 months of this study, including the 3 months of treatment. These results demonstrate that Uro-Vaxom is a valuable agent for prophylaxis of recurrent cystitis.
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