Objective Evaluate long-term effectiveness, safety and tolerability of OM-89 (Uro-Vaxom®), an oral immunostimulant derived from bacterial lysates of Escherichia coli, in the prophylactic management of recurrent urinary tract infections (rUTIs) in women in a real-world outpatient gynecology setting. Methods Retrospective, multicenter observational study based on data from women with a diagnosis of rUTI who received a single 90-day cycle of OM-89 therapy. Data were collected from medical records at the Mexican Institute for Infectious Diseases in Obstetrics and Gynecology (IMIGO) clinic in Monterrey, Mexico, between January 2023 and March 2024.. Primary outcomes included time to UTI recurrence, number of UTI episodes post-treatment, and use of antibiotics to treat a UTI. Secondary outcomes included recurrence-free interval and incidence of adverse events. Results A total of 208 women with recurrent UTIs were included. 72.1% received a single OM-89 90-day cycle, while 27.9% underwent two or more 90-day cycles. The mean recurrence-free interval after one OM-89 cycle was 5.3 ± 2.6 years, and 4.6 ± 2.5 years for those with OM-89 multiple cycles. Post-treatment bacterial cultures revealed a significant reduction in bacterial resistance 72.4% of urine samples and 37.0% of vaginal samples (p < 0.001). Conclusion A single 90-day course of OM-89 was associated with a long term reduction in UTI recurrences and antibiotic use in women with rUTIs. These findings support its use as a safe and effective non-antibiotic preventive strategy in clinical practice. Keywords: Recurrent urinary tract infections, OM-89, Uro-Vaxom®, oral immunotherapy, antibiotic stewardship, women's health, E. coli, resistance.
Tirán-Saucedo et al. (Tue,) studied this question.
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