Abstract
Vaginal laxity (VL) and genitourinary syndromes of menopause (GSM) create physical, psychological, and functional problem for women and their partners. We aimed to evaluate the efficacy and safety of micro-focused ultrasound (MFU) therapy performed twice in the vaginal canal in a patients with VL and GSM. A total of 20 women with GSM and VL were treated with MFU Ultravera by Hironic. The treatment course consisted of two vaginal applications of MFU at an interval of 6 weeks. The clinical effects of the protocol were evaluated using the Vaginal Laxity Questionnaire (VLQ), the Vaginal Health Index (VHI), and the Female Sexual Function Index (FSFI). The overall values of the vaginal laxity evaluation for the total subject population showed a statistically significant improvement between the baseline and the findings at 3 and 6 months after treatment. The effect of therapy was consistent across all domains of FSFI. It peaked at the 6 week follow-up visit (from 26.5 to 32) and plateaued at 12 weeks and 6 months. There was a significant VHI improvement over time, with the greatest and most significant change between the study entry and 21 days after treatment; the VHI score leveled off up to 3 months after the procedures. MFU therapy, performed twice in the vaginal canal, showed promising efficacy and safety profiles, meriting further investigation.