MedicalResearch.com Interview with:
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.
MedicalResearch.com: What types of patients may benefit?
Response: Vaginal laxity is a condition that is undergoing re-assessment in the medical and sexuality literature. We originally thought that laxity was only the result of childbirth trauma, however we now realize that millions of women suffer from this condition and have varying etiologies including aging, genetic predisposition, medical (asthma), hormonal, behavioral (smoking, etc.) and lifestyle influences that can all impact the integrity of the vaginal tissue and result in laxity. Millions of women with changes in sexual function as a result of reduced vaginal integrity or complaints of vaginal laxity can benefit.
MedicalResearch.com: What should readers take away from your report?
Response: Women need not suffer in silence – vaginal laxity is an underdiagnosed and under recognized medical condition and concern that can negatively impact sexual function, self-esteem, and quality of life.
Women can and should be empowered to be self-determined to enhance and improve their sexual function. Geneveve is a safe, effective, single session 30-minute outpatient procedure which has demonstrated efficacy in treating vaginal laxity.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: We are currently expanding our research initiative to include a large pivotal study to further validate our results. The company currently has an Investigational Device Exemption (IDE) under review by the Food and Drug Administration (FDA) to begin the VIveve Treatment of the Vaginal Introitus to EValuate Efficacy (VIVEVE II) study. The study will begin in the U.S. and Canada when the FDA completes its review and if approval is received. The study would be one of, if not the largest and most scientifically rigorous, energy-based trials in sexual medicine.
In addition, multiple research papers are in-press and others have been submitted for publication in peer reviewed journals.
MedicalResearch.com: Is there anything else you would like to add?
Response: It is important to know that Viveve Medical, Inc. is a global women’s health and wellness company advancing new therapeutic solutions to improve women’s overall well-being and quality of life and is committed to evidence-based science. The Viveve® System has been approved for use in more than 50 countries worldwide.
Disclosure: I am currently a medical consultant for the company and have served as the medical monitor for the published trial. I have a longstanding history of medical and scientific collaboration with this company.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Krychman, Michael et al.
The Journal of Sexual Medicine , Volume 14 , Issue 2 , 215 – 225
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.