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Abstract
Purpose:
We wanted to investigate the efficacy and safety of the immuno- therapeutic 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 (>10 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:
Infill 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 く 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.
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 | Fig. 2.Cumulative survival curve of the cystitis patients during the 6 months of the study. |
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