SAN DIEGO – The first randomized, sham-controlled study of a radiofrequency energy-based device for vaginal laxity showed a significant and sustained effect, and likely raises the bar on vaginal rejuvenation options, , said during a presentation at the annual Masters of Aesthetics Symposium.
“There are a lot of women who have vaginal laxity, vaginal atrophy, and other issues, and this is something that seems to help,” she said. No devices have yet received female rejuvenation/vaginal function indications from the Food and Drug Administration.
Current in-office procedures involve the delivery of radiofrequency (RF) energy, which appears to stimulate collagen production, and the use of fractionated lasers to target the epithelium. “RF devices tend to be easier to use,” said Dr. Kilmer, director of the Laser and Skin Surgery of Northern California, Sacramento. “They’re smaller devices, do not require as much laser training, and they tend to be less expensive. There’s no plume or odor with any of the RF devices.”
She discussed the results of the Viveve Treatment of the Vaginal Introitus to Evaluate Effectiveness (Viveve I) study, conducted at nine sites in four countries, which examined thein 155 premenopausal women. The study subjects were randomized to one of two groups: the treatment group received 90 J/cm2 for five passes and the sham group received 1 J/cm2 for five passes ( ).
The researchers used the Vaginal Laxity Questionnaire (VSQ), which grades vaginal tone on a 7-point scale that ranges from very loose (0) to very tight (7), and the Female Sexual Function Index (FSFI) to collect patient-reported outcomes at one, three, and six months. Subjects had to have a VSQ score of 3 or less to participate in the study.
At 6 months, patients in the treatment group were more than 3 times as likely to have no vaginal laxity, compared with their counterparts in the sham group (P less than or equal to 0.006). In addition, more than half of patients in the treatment group moved at least 2 points on the VSQ scale toward a “tighter” vagina.
“Even a one-point increase in tightness will be significant for women,” said Dr. Kilmer, who has used the Viveve device in her practice but was not part of this study.
Based on responses to the FSFI questionnaire, the researchers observed a significant and sustained improvement in sexual function after a single treatment among patients in the treatment group, compared with those in the sham group. The placebo effect didn’t rise above “dysfunctional” at six months, and rate of treatment emergent adverse events was similar between the treatment and sham groups (11.1% vs. 12.3%, respectively), she said.
The researchers also reported the following patient tolerability variables: warmth during the procedure (96% in the treatment group vs. 19% in the sham group, respectively); cool sensation during the procedure (42% vs. 75%), and stopped procedure due to discomfort (1% in each group).
Dr. Kilmer explained that RF heating of the skin and mucosa provides immediate contraction of collagen, long-term stimulation of new collagen production, as well as increased blood flow and restoration of nerve signaling, which results in normal vaginal lubrication. “The critical RF temperature is in the 35 to 47 degree range,” she said. “Very few people can tolerate above 42 degrees.”
Similarly, good results were noted in a pilot study of themanufactured by ThermoGen in 23 patients who underwent three treatments one month apart ( ). All patients experienced significant change with about a 50% reduction in symptoms.
“Patients are very happy with this treatment,” said Dr. Kilmer, who is also a professor of dermatology at the University of California, Davis Medical Center. “It may not be the absolute home run, but I think it’s very safe ... Most people say it lasts about six months then they’ll start to see some of their symptoms coming back.”
Dr. Kilmer reported that she is a member of the medical advisory board for Allergan, Cytrellis, Lumenis, Merz, Miramar, Sienna Labs, Syneron/Candela, Zarin, Zeltiq, and Zift. She has also received research support from those companies as well as from Cutera, Cynosure, Lutronic, R2 Derm, Solta/Valeant, and Ulthera.