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.
Healthy postmenopausal subjects from 1 to 15 years since their last menstrual cycle.
Willingness to refrain from using alternative therapies for treatment of symptoms of GSM, unless medically necessary, through the duration of this study.
Moderate to severe dyspareunia associated with GSM. (i.e., ≥4 on the 11-point patient-reported numeric rated dyspareunia scale).
Subjects who are sexually active (i.e. have had or have attempted to have sexual activity with vaginal penetration within approximately 1 month of screening visit).
Subjects on Hormone Therapies (HT), systemic or local, or within 6 months of cessation of HT prior to inclusion in the study.
Subjects with bleeding disorders.
Subjects with any sexually transmitted disease.
Subjects on prescribed anticoagulants such as antiplatelets and anticoagulants (Heparin, Warfarin, Clopidogrel, Apixaban, Rivaroxaban).