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Uro-vaxom (OM-89) for chronic UTI prevention: an updated meta-analysis, meta-regression and trial sequential analysis of recent clinical evidence

B. Porto, A. Almeida, B. Terada, F. G. Gonçalves, C. C. Passerotti, R. Sardenberg, J. P. Otoch, J. A. D. da Cruz

Minerva urology and nephrology, 2025

677 participants · 4 citations

Abstract

INTRODUCTION

Recurrent urinary tract infections (UTIs) are a common health issue that affects patients' quality of life and healthcare systems. To reduce antibiotic use, non-antimicrobial treatments, such as Uro-Vaxom (OM-89), have been proposed to prevent UTI recurrence by enhancing immune response. Still, despite being available for many years, the evidence for its effectiveness remains unclear. This updated systematic review and meta-analysis aims to evaluate the efficacy of OM-89 in reducing UTI recurrence, increasing sample size compared to previous reviews.

EVIDENCE ACQUISITION

A systematic review was conducted using MEDLINE, Embase, Scopus, Cochrane, Web of Science, and Google Scholar, following the PRISMA guidelines. We included randomized controlled trials (RCTs) comparing OM-89 with placebo in adult patients with a history of recurrent UTIs. Study selection and data extraction were performed by multiple reviewers, and a random-effects model was used for data pooling. Our primary outcome was the recurrence rate of symptomatic UTIs, while secondary endpoints included the rate of positive urine cultures at 3 and 6 months post-intervention. Risk of bias was assessed using the Cochrane Risk of Bias 2 tool, and statistical analysis was conducted using RStudio software. Additionally, we performed a meta-regression incorporating all included studies for primary endpoint.

EVIDENCE SYNTHESIS

We retrieved eight RCTs, comprising 674 patients in the OM-89 group and 677 patients…

How strong is the evidence?

Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 677 participants or records.

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