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Tissue structure post-ThermiVa

Clinical and patient-reported results show transcutaneous temperature-controlled radiofrequency (RF) treatment, with ThermiVa (Thermi), improves sexual satisfaction, atrophic vaginitis and vulvovaginal laxity. Now, histological findings are helping to validate results, including, for the first time, showing evidence of treatment-related neurogenesis, according to a small study published May 2018 in Dermatologic Surgery.

Ten women, ages 23 to 60 years, with mild-to-moderate vulvovaginal laxity, underwent ThermiVA treatment. Five of those women agreed to pre- and post-treatment biopsies. The women had three ThermiVa treatments, performed four weeks apart.

Researchers found significant improvement in mild-to-moderate vulvovaginal laxity through 120 days post-treatment. They also found sexual satisfaction improved significantly by day 60. Atrophic vaginitis significantly improved by day 120. And while orgasmic dysfunction, which impacted 80% of subjects, and stress urinary incontinence, affecting 90% of the women, improved steadily through 120 days, those were not significant changes.

Histology showed post-treatment increases in collagen, elastin, vascularity and small nerve endings, according to the study.

Sexual Satisfaction Measures

Subjects reported a mean 2.8 in sexual satisfaction scoring at the study’s start. At baseline, day 10, 30, 60 and 120, subjects completed the Millheiser Sexual Satisfaction Questionnaire, rating satisfaction from vaginal intercourse as 1 (none) to 6 (excellent). They also completed the Female Sexual Function Index, looking at sexual function and satisfaction. According to the study, there was an insignificant uptick in the mean sexual satisfaction score at day 10 and a significant change, with a mean 4.9 score, at day 60. At day 120, the mean was 4.3.

Interestingly, women in the study reported a significant uptick in sexual interest from baseline at day 120. They also reported a notable increase in sexual arousal during intercourse.

“Perhaps more importantly, subjects reported improved confidence in their ability to become aroused during sexual activity from baseline,” the authors write.

About the Histologic Findings

Post-treatment biopsies confirmed subtle but significant results linked with rejuvenated skin and mucosa. This included improved epithelial maturation, vaginal transudate restoration, increased collagen, new elastic fibers and increased vascularity, they write.

In what the researchers write is the first report of neurogenesis or neuroregeneration post transcutaneous temperature controlled RF treatment, they found a subtle increase in nerve fibers in three of the five samples. But they note their assessment of small nerve fiber density using neuronal stain was not done in an ideal manner and should be confirmed using more standardized methods for such an assessment.

Orgasmic dysfunction improvement with ThermiVa treatment was more evident in a clinical report by ThermiVa’s inventor Red Alinsod, M.D., published in Lasers in Surgery and Medicine in 2016. In that study of 25 women, 23 subjects reported an average 50% reduction in time to orgasm, post ThermiVa treatment. While two of the women had a minimal response, the others reported vaginal tightening, increased vaginal moisture and improved sensitivity.

“All anorgasmic patients reported the ability to achieve orgasms,” according to Dr. Alinsod, a uro-gynecologist and aesthetic vulvovaginal surgeon, who practices in Laguna Beach, Calif.

Nine patients in Dr. Alinsod’s study reported experiencing more intense orgasms.

Dr. Alinsod, says that, since 2015, when ThermiVa was launched, about 85,000 treatments have been performed worldwide. No serious adverse reactions, including blisters, burns or scarring, have been reported. 


Disclosure:
ThermiGen supported the study in Dermatologic Surgery. Dr. Alinsod is a consultant for and receives royalties from Thermi and Cooper Surgical, and is a consultant for Hautlabs, BTL and Lutronic.