J Korean Med Sci.  2010 Mar;25(3):435-439. 10.3346/jkms.2010.25.3.435.

A Prospective Multi-center Trial of Escherichia coli Extract for the Prophylactic Treatment of Patients with Chronically Recurrent Cystitis

• Kim KS
• Kim JY
• Jeong IG
• Paick JS
• Son H
• Lim DJ
• Shim HB
• Park WH
• Jung HC
• Choo MS

• KMID: 1778040
• DOI: http://doi.org/10.3346/jkms.2010.25.3.435

Abstract

We have assessed the efficacy and safety of Escherichia coli extract (ECE; Uro-Vaxom(R)) which contains active immunostimulating fractions, in the prophylactic treatment of chronically recurrent cystitis. Forty-two patients with more than 2 episodes of cystitis in the proceeding 6 months were treated for 3 months with one capsule daily of ECE and observed for a further 6 months. The primary efficacy criterion was the number of episodes of recurrent cystitis during the 6 months after treatment compared to those during the 6 months before treatment. At the end of the 9-month trial, 34 patients (all women) were eligible for statistical analysis. Their mean age was 56.4 yr (range, 34-75 yr), and they had experienced recurrent urinary tract infections for 7.2+/-5.2 yr. The number of recurrences was significantly lower during the 6-month follow-up period than during the 6 months preceding the trial (0.35 vs. 4.26, P<0.001). During the follow-up, 28 (82.4%) patients had no recurrences and 4 (11.8%) had 1 each. In patients who relapsed, ECE alleviated cystitis symptoms, including painful voiding, frequency and urgency. There were no serious adverse events related to the study drug. Our study demonstrates the efficacy and safety of ECE in the prophylactic treatment of chronically recurrent cystitis.

Keyword

Cystitis; Immunization; Escherichia coli; OM-8930; Prevention and Control

MeSH Terms

Adult
Aged
Cell Extracts/immunology/*therapeutic use
Cystitis/*drug therapy/immunology/microbiology/*prevention & control
Escherichia coli/*chemistry/immunology/pathogenicity
Female
Humans
Middle Aged
Prospective Studies
Recurrence
Cell Extracts

Figure

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  Fig. 1 Changes of urgency in recurred patients (n=6).

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  Fig. 2 Changes of painful voiding symptom in recurred patients (n=6).

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  Fig. 3 Changes of frequency in recurred patients (n=6).

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