Effectiveness of Individualized Autovaccine Immunotherapy in Women With Recurrent Urinary Tract Infections: A Prospective Cohort Study

Abstract Background Recurrent urinary tract infections (rUTIs) disproportionately affect older women and are frequently driven by nonmodifiable risk factors (nmRFs). This study evaluated the effectiveness, safety, and patient-reported outcomes (PROs) of personalized sublingual immunoprophylaxis in women with rUTIs. Methods Prospective, single-center, noncomparative observational cohort study. Women with rUTIs received a Uromune® autovaccine prepared from inactivated strains isolated from each patient's urine culture (UC). Recurrence episodes and UC results were recorded at baseline and at 3, 9, and 12 months. PROs (daily activity, QAct; emotional distress, QEm) were assessed in a predefined substudy. Longitudinal mixed-effects and population-averaged models evaluated change over time and explored baseline risk factors as effect modifiers. Results Of 119 screened women, 100 were enrolled (median [IQR] age: 73 [61–80] years); most presented multiple nmRFs. Median (IQR) rUTI episodes decreased from 4 (3–5) at baseline to 0 (0–2) at 3 months and remained 1 (0–2) and 1 (0–3) at 9 and 12 months (all P < .001). Approximately 40% were UTI-free in each follow-up interval. UC negativity was 50.7% at 3 months, decreased at 9 months (25.9%), and increased again at 12 months (45.5%), remaining higher than baseline. QEm improved significantly at 3 and 12 months; QAct showed a trend toward improvement. Vaccine-related adverse events were uncommon (6%) and mild. Conclusions Individualized sublingual immunoprophylaxis was safe and associated with sustained reductions in rUTI episodes, improved microbiological findings, and better emotional well-being, suggesting a potential role as a nonantibiotic preventive strategy. These observational findings are hypothesis-generating and warrant confirmation in controlled studies.