12-Years Real-Life Data on Successful Management of Recurrent Urinary Tract Infections by OM-89 and Its Impact on...

Evaluate long-term effectiveness, safety and tolerability of OM-89 (Uro-Vaxom®), an oral immunomodulator 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.

Retrospective, single center observational study based on data from women with a diagnosis of rUTI who received OM-89 as a single 90-day cycle or two or more cycles. 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 outcome was the time free of UTI recurrence. Secondary outcomes were the risk factor profiles in the treated groups, urine and vaginal antibiotic resistance profiles and the incidence of adverse events.

A total of 208 women with rUTI 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 showed a significant reduction in bacterial resistance in 72.4% of urine samples and in 37.0% of vaginal samples (p < 0.001).

A single 90-day course of OM-89 was associated with a long-term reduction in UTI recurrences and antibiotic resistance in women with rUTIs. These findings support its use as a safe and effective nonantibiotic preventive strategy in clinical practice.