MedicalResearch.com Interview with:
Dr. Michael Krychman
Dr. Krychman is Executive Director, President, and CEO of the Southern California Center for Sexual Health and Survivorship Medicine and Associate Clinical Professor at the University of California, Irvine, Department of Obstetrics and Gynecology. He is a Member of the International Society for the Study of Women’s Sexual Health (ISSWSH), The International Society for Sexual Medicine (ISSM) and a Certified Sexual Counselor by the American Association of Sexuality Educators, Counselors and Therapists (AASECT). He served as a member of the Standards Committee for the International Society for Sexual Medicine during their 2016 International Consensus Meeting.
MedicalResearch.com: What is the background for this technology and study? What are the main findings?
Response: Viveve Medical, Inc. is a women’s health and wellness company committed to advancing new solutions to improve women’s overall well-being and quality of life. The internationally patented Viveve® technology and the GENEVEVE™ treatment, incorporates clinically-proven, cryogen-cooled monopolar radiofrequency (CMRF) energy to uniformly deliver non-ablative, deep penetrating volumetric heat into the submucosal layer of the vaginal introitus (opening) while gently cooling surface tissue to generate robust neocollagenesis. One 30-minute in-office session tightens and restores the tissue around the vaginal introitus addressing the common medical condition of vaginal laxity and can improve a woman’s sexual function.
VIVEVE I is a landmark study. Results of the VIVEVE I clinical study, “Effect of Single-Treatment, Surface-Cooled Radiofrequency Therapy on Vaginal Laxity and Female Sexual Function: The VIVEVE I Randomized Controlled Trial,” were recently published in the February 2017 issue of the Journal of Sexual Medicine (JSM) under the Female Sexual Function category. Some of my high-level thoughts to reiterate from this study are:
It is the first-ever large, randomized, sham-controlled study to demonstrate the safety and efficacy of energy-based procedures in gynecological applications, including vaginal laxity, which is a significant medical condition affecting millions of women worldwide that may lead to a reduction in sexual function.
The primary endpoint of the VIVEVE I study was a comparison of the proportion of women reporting no vaginal laxity in the treatment group versus the sham group at 6 months post-treatment.
Subjects receiving the active treatment were three times more likely to report no vaginal laxity at six months versus the sham group (p-value = 0.006).
Statistically significant and sustained improvement in sexual function (baseline FSFI total score ≤26.5) after a single treatment, with an adjusted mean difference in the active group vs sham group of 3.2 at 6 months (p-value = 0.009). “Placebo Effect” in the sham group did not rise above dysfunctional (FSFI ≤26.5) and diminished at 6 months.
Statistically significant improvement in sexual function was achieved in 93% of subjects in the active group vs the sham group in two individual key domains of FSFI (p-value = 0.007).
Bottom line: Geneveve is a safe effective treatment that can be performed as an outpatient in one 30-minute visit to improve sexual function as it has been affected by vaginal laxity.