Vaginal Estrogen for Urinary Tract Infection Prevention: A Narrative Review of Evidence, Guidelines, and Regulatory Gaps
Abstract
BACKGROUND: Recurrent urinary tract infections (rUTIs) are common in peri- and postmenopausal women and impose substantial symptom, quality of life, and antimicrobial stewardship burdens, with particularly high incidence and hospitalization costs documented in England and UK primary care populations. Vaginal estrogen, by restoring urogenital epithelium and the Lactobacillus-dominant microbiome, is recommended in several guidelines for preventing rUTI, including UK antimicrobial prescribing guidance for rUTIs and European Association of Urology recommendations. However, most formulations are licensed only for genitourinary syndrome of menopause, not for urinary tract infection (UTI) prophylaxis. This creates a mismatch between the growing clinical evidence base and the absence of a specific regulatory indication for rUTI prevention across major regulatory agencies, including the US Food and Drug Administration (FDA), the European Medicines Agency, and the UK Medicines and Healthcare products Regulatory Agency, which may contribute to underuse and clinician uncertainty. OBJECTIVES: The objective of this review is to summarize the evidence on vaginal estrogen for prevention of rUTIs in peri- and postmenopausal women, with a particular focus on its use alone and in combination with antibiotic therapy, and on the gap between clinical guideline recommendations and regulatory product labeling. METHODS: We conducted a structured narrative review focusing on randomized controlled…
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