Intravaginal Negative Pressure Medical Device for Treatment of Genitourinary Syndrome of Menopause (GSM)

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2025
This pilot study aims to evaluate the safety and effectiveness of the VITA AV Clinical System over a period of up to three months after the last treatment, compared to a sham device. The study focuses on improving vaginal signs and symptoms of Genitourinary Syndrome of Menopause (GSM) in post-menopausal women who experience moderate to severe pain during intercourse (dyspareunia). Long-term follow-up visits will assess the ongoing effectiveness and durability of the treatment, while also collecting safety data.
Epistemonikos ID: f98b9d6c2a8d32a7867a2f93b848b25309704c59
First added on: Mar 27, 2025