027 VIVEVE I: VIveve Treatment of the Vaginal Introitus to Evaluate Effectiveness: An Interim Analysis

Abstract

Vaginal tissue laxity has often been overlooked as a contributing etiological factor to female sexual dysfunction. Vaginal looseness can lead to diminished physical sensation during intercourse. This reduction of sensation is often coupled with a reduction in sexual satisfaction, which can also impact a woman’s relationship with her sexual partner. The Viveve System is a monopolar radiofrequency system that uses surface cooling and radiofrequency (RF) energy delivery to provide a nonablative and minimally-invasive approach to creating heat deep within the layers of vaginal soft tissue, while keeping the surface cool. The Viveve procedure consists of a single, 30-minute, office-based, treatment of the vaginal introitus to improve sexual function. Interim prospective, controlled, randomized data is promising and presented here. A prospective, longitudinal, randomized, blinded, controlled, multi-center clinical study is ongoing. This study is the first of its kind ever done for the medical condition of vaginal laxity. Over 150 subjects were randomized in a 2:1 ratio to either the active treatment group (90 J/cm2) or sham group (1 J/cm2). Subjects will be followed up at 72 hrs, 10 days, and 1, 2, 3, and 6 months post-treatment. Clinical scales for assessment include Female Sexual Function Index (FSFI), Vaginal Introitus Laxity Inventory (VALI), Female Sexual Distress Scale-Revised (FSDS-R), and the Viveve System Questionnaire (VSQ).