Is Uriexo (Uro-Vaxom) Effective for Urinary Conditions?
Yes, Uro-Vaxom (OM-89) is effective and recommended for preventing recurrent urinary tract infections in women, with strong evidence showing it reduces UTI recurrence for 6-12 months compared to placebo. 1
Evidence for Effectiveness
Guideline-Level Recommendations
The 2018 Journal of Urology guidelines on recurrent UTI treatment explicitly state that Uro-Vaxom is safe and effective in reducing UTI recurrence for 6 to 12 months compared to placebo, based on meta-analyses of randomized controlled trials. 1
The 2024 European Association of Urology guidelines give a strong recommendation to use immunoactive prophylaxis (which includes Uro-Vaxom) to reduce recurrent UTI in all age groups. 1
Clinical Trial Evidence
A high-quality double-blind RCT of 120 patients showed that Uro-Vaxom significantly decreased the number of UTI recurrences, total antibiotic consumption, bacteriuria, and dysuria compared to placebo over 6 months, with protective effects lasting an additional 5 months after treatment cessation. 2
A 2025 systematic review confirmed that Uro-Vaxom decreased UTI recurrence, was well-tolerated, and reduced the need for antibiotic therapies, though it noted methodological limitations in some included studies. 3
Mechanism and Dosing
Uro-Vaxom is an oral vaccine containing a lyophilized lysate of 18 selected Escherichia coli strains that triggers immunity through increased lymphocyte and macrophage activity. 1
Longer protection (beyond 6-12 months) may be achieved with 3 monthly 10-day booster courses. 1
Clinical Context and Positioning
When to Use Uro-Vaxom
Use Uro-Vaxom as part of a stepwise approach to recurrent UTI prevention: first counsel on risk factor avoidance, then try non-antimicrobial measures (including immunoactive prophylaxis), and reserve continuous antimicrobial prophylaxis for when these interventions fail. 1
For postmenopausal women, vaginal estrogen replacement receives a strong recommendation and should be prioritized alongside or before Uro-Vaxom. 1
Antibiotic Stewardship Benefits
A critical advantage of Uro-Vaxom is reducing antibiotic exposure, which is essential given that fluoroquinolones and cephalosporins cause significant collateral damage to fecal microbiota and increase Clostridium difficile infection risk. 1
By the sixth month of treatment in clinical trials, patients receiving Uro-Vaxom were consuming no antibiotics, compared to ongoing antibiotic use in placebo groups. 2
Safety Profile
- Uro-Vaxom is safe with a low rate of adverse events, with only mild side effects reported in approximately 3% of patients (4 out of 120 in one trial). 1, 2
Important Caveats
The available evidence focuses almost exclusively on women; data in men are limited. 3
While effective, the retrospective nature of several studies and variability in study design prevent precise quantification of treatment effect magnitude. 3
Uro-Vaxom is available in Europe but may not be accessible in all countries, including the United States where it is not FDA-approved.