Prevention of recurrent urinary tract infections with immuno-active E. coli fractions: a meta-analysis of five placebo-controlled double-blind studies

Abstract

A meta-analysis was performed on five studies conducted over the last decade to demonstrate a positive effect for the drug Uro-Vaxom compared with Placebo in double-blind studies in patients with urinary tract infection (601 women), with special reference to the prevention of recurrences over an observation period of 6 months, the treatment being given for the first 3 months. The five studies were similar in design. The analysis by means of the Wilcoxon-Mann-Whitney test showed superiority of Uro-Vaxom in all five studies, (P<1%). The summarising Mann-Whitney (MW) statistics also indicated superiority with the Mann-Whitney value being 0.684. In all studies, the Uro-Vaxom group was statistically significant and clinically relevant superior to control with respect to the reduction of the frequency of UTIs and to dysuria, bacteriuria and leucocyturia. The confidence intervals (CI)s were small (0.64-0.72). The drug was well tolerated and compliance of patients was excellent in all studies. Oral immunotherapy with the Uro-Vaxom Escherichia coli (E. coli) extract is an effective prophylactic approach in the prevention of UTIs.