Korean J Urol.  2007 Apr;48(4):428-432. 10.4111/kju.2007.48.4.428.

Efficacy and Safety of Uro-Vaxom Treatment for Patients with Recurrent Cystitis: An Open Multicenter Study

• Lee SJ
• Kim SJ
• Cho YH
• Woo YN
• Kim BW
• Kim YS
• Chang SG
• Kim ME
• Kim CS
• Lee JG
• Sim BS
• Kim HJ
• Chung BH
• Cho IR
• Lee SD

• KMID: 1997111
• DOI: http://doi.org/10.4111/kju.2007.48.4.428

Abstract

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 (> or =10(3)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.

Keyword

Female; Cystitis; Escherichia coli; Uro-Vaxom

MeSH Terms

Adult
Cystitis*
Dysuria
Escherichia coli
Female
Humans
Incidence
Recurrence

Figure

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  Fig. 1. Cumulative recurrence rate of cystitis by visit.

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  Fig. 2. Cumulative survival curve of the cystitis patients during the 6 months of the study.

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  Fig. 3. Ventilation of the cases as a function of the number of recurrences during the 6 months before the start of the study and their distribution during the 6 months of the study (p< 0.01).

• 

  Fig. 4. Frequency of symptoms over time.

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