Vaginal high-intensity focused ultrasound in women with genitourinary syndrome of menopause: a prospective exploratory study.

Introduction: Energy-based therapies for genitourinary syndrome of menopause (GSM) remain controversial, and evidence for vaginal high-intensity focused ultrasound (HIFU) is limited. The aim of this study was to evaluate the safety and exploratory efficacy of vaginal HIFU in women with GSM. Methods: In this prospective, single-arm, exploratory study, women with GSM underwent vaginal HIFU and were followed for 24 weeks. Women with prior gynecologic surgery or treated malignancy were eligible if ≥6 months had elapsed and clinical stability was confirmed. Patient-reported outcomes included visual analog scale (VAS) scores for GSM symptoms, the Vulvovaginal Symptoms Questionnaire (VSQ), the Female Sexual Function Index (FSFI), and the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). Objective measures included the Vaginal Health Index (VHI), vaginal pressure, pelvic organ prolapse quantification, vaginal pH, and vaginal microbiome profiling. The primary endpoint was the percent change from baseline to 12 weeks in the VAS score of the participant-identified most bothersome GSM symptom. Results: Eighteen women comprised the full analysis set. The primary endpoint showed a reduction in symptom severity (mean percent change -67.7%; 95% confidence interval [CI], -87.6% to -47.7%). Individual VAS scores decreased over time and were generally maintained throughout follow-up. The VSQ improved at 24 weeks (-40.4%; 95% CI, -64.6% to -16.2%), and the ICIQ-SF improved at 12 weeks (-29.0%; 95% CI, -54.6% to -3.4%), although this improvement was not sustained at 24 weeks. Total FSFI scores did not change. Improvements were observed in VHI and vaginal pressure, while vaginal pH and microbiome composition remained stable. No Grade ≥3 adverse events occurred. Discussion: In this exploratory study, vaginal HIFU was associated with improvements in the most bothersome GSM symptom and selected objective measures without serious adverse events. However, given its single-arm design and small sample size, no definitive conclusions regarding its efficacy or safety can be drawn, and further studies are needed to elucidate the mechanisms of action, optimize treatment parameters, characterize the safety profile, and determine the clinical utility of vaginal HIFU.