VIVEVE I STUDY
The largest randomized, double-blind and sham-controlled study with 164 patients. Study showed a significant improvement in arousal, lubrication and orgasm versus the sham treatment. Pilot study showed sustained results out to 12-months.
Introduction: Vaginal laxity is a highly prevalent and undertreated medical condition.
Aim: To evaluate the efficacy and safety of surface-cooled, monopolar radiofrequency (RFc) therapy for the treatment of vaginal laxity in the VIVEVE I trial.
Methods: The VIVEVE I trial was a prospective, randomized, single-blinded, and sham-controlled study. Nine study centers in Canada, Italy, Spain, and Japan participated. Women presenting with vaginal laxity were screened and informed consent was obtained.Major study inclusion criteria were premenopausal status, age at least 18 years, at least one full-term vaginal delivery, and normal genito-pelvic examination results. Enrolled subjects were randomized (2:1) to receive RFc therapy (Active [90 J/cm2] vs Sham [1 J/cm2], respectively) delivered to the vaginal tissue.
Main Outcome Measures: The primary efficacy outcome was the proportion of randomized subjects reporting “no vaginal laxity” (Active vs Sham) at 6 months postintervention, which was assessed using the Vaginal Laxity Questionnaire. Treatment-emergent adverse events were evaluated in all treated subjects. Secondary efficacy end points included change on the Female Sexual Function Index (FSFI) and the revised Female Sexual Distress Scale (FSDS-R).
Results: No vaginal laxity was achieved by 43.5% and 19.6% (P ¼ .002) in the Active and Sham groups, respectively. Differences in FSFI and FSDS-R total scores (Active vs Sham) were 1.8 (P ¼ .031) and “2.42 (P ¼ .056), respectively, in favor of Active treatment. Treatment-emergent adverse events were reported by 11.1% and 12.3% of subjects in the Active and Sham arms, respectively.
Conclusion: The VIVEVE I trial is the first randomized, controlled, blinded, clinical study of RFc for the treatment of vaginal laxity. A single treatment of RFc therapy was found to be safe and associated with both improved vaginal laxity and improved sexual function. The results from this trial support the use of a novel nonsurgical therapy for vaginal laxity, a prevalent and undertreated condition.
Krychman M, Rowan CG, Allan BB, et al. Effect of Single-Treatment, Surface-Cooled Radiofrequency Therapy on Vaginal Laxity and Female Sexual Function: The VIVEVE I Randomized Controlled Trial.
J Sex Med 2017;14:215e225. Copyright 2016, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.
*Data was submitted to support our FDA clearance for coagulation and hemostasis.