Typically, radiofrequency device treatments:
- are used for outpatient procedures
- do not require topical anesthesia
- are constructed to emit focused electromagnetic waves
- are applied to vaginal, vulvar, or vaginal introital or vestibular tissue
- deliver energy to the deeper connective tissue of the vaginal wall architecture.
Radiofrequency device energy can be monopolar, unipolar, bipolar, or multipolar depending on design. Design also dictates current and the number of electrodes that pass from the device to the grounding pad. Monopolar is the only type of radiofrequency that has a grounding pad; bipolar and multipolar energy returns to the treatment tip.
Radiofrequency devices typically are FDA 510(k)-cleared devices for nonspecific electrocoagulation and hemostasis for surgical procedures. None are currently FDA cleared in the United States for the treatment of vaginal or vulvar laxity or genitourinary syndrome of menopause (GSM). These energy-based devices aim to induce collagen contraction, neocollagenesis, vascularization, and growth factor infiltration to restore the elasticity and moisture of the underlying vaginal mucosa. Heat shock protein activation and inflammation activation are thought to be the underlying mechanisms of action.2–5
Treatment outcomes with 2 radiofrequency devices
Multiple prospective small case series studies have reported outcomes of women treated with the ThermiVa (ThermiAesthetics LLC) radiofrequency system.3,4 Typically, 3 treatments (with a between-treatment interval of 4 to 6 weeks) were applied. The clinical end point temperature had a range of 40°C to 45°C, which was maintained for 3 to 5 minutes per treated zone during 30 minutes’ total treatment time.
Some participants self-reported improvement in vaginal laxity symptoms with the 3 treatments. In addition, women reported subjective improvements in both vaginal atrophy symptoms and sexual function, including positive effect in multiple domains. No serious adverse events were reported in these case series. However, there was no placebo-controlled arm, and validated questionnaires were not used in much of this research.3,4
In another trial, the ThermiVa system was studied in a cohort of 25 sexually active women with self-reported anorgasmia or increased latency to orgasmic response.6 Participants received 3 treatments 4 weeks apart. Approximately three-quarters of the participants reported improved orgasmic responsivity, vaginal lubrication, and clitoral sensitivity. Notably, this research did not use validated questionnaires or a placebo or sham-controlled design. The authors suggested sustained treatment benefits at 9 to 12 months. While repeat treatment was advocated, data were lacking to support the optimal time for repeat treatment efficacy.6
A cryogen-cooled monopolar radiofrequency device, the Viveve system (Viveve Medical, Inc) differs from other radiofrequency procedures because it systematically cryogen cools and protects the surface of the vaginal mucosal tissue while heating the underlying structures.
The Viveve system was evaluated in 2 small pilot studies (24 and 30 participants) and in a large, randomized, sham-controlled, prospective trial that included 108 participants (VIVEVE I trial).5,7,8 Results from both preliminary small studies indicated that participants experienced significant improvement in overall sexual function at 6 months. In one of the small studies (in Japanese women), sustained efficacy at 12 months posttreatment was reported.7 Neither small study included a placebo-control arm, but they did include the use of validated questionnaires.
In the VIVEVE I trial (a multicenter international study), treatment in the active group consisted of a single, 30-minute outpatient procedure that delivered 90 J/cm2 of radiofrequency energy at the level just behind the hymenal ring behind the vaginal introitus. The sham-treated group received ≤1 J/cm2 of energy with a similar machine tip.8
Statistically significant improvements were reported in the arousal and orgasm domains of the validated Female Sexual Function Index (FSFI) for the active-treatment group compared with the sham-treated group. In addition, there were statistically significant differences in the FSFI and the Female Sexual Distress Scale–Revised total scores in favor of active treatment. Participants in the active-treatment arm reported statistically significant improvement in overall sexual satisfaction coupled with lowered overall sexual distress.8
These data are provocative, since the Viveve treatment demonstrated superior efficacy compared with the sham treatment, and prior evidence demonstrated that medical device trials employing a sham arm often demonstrate particularly large placebo/sham effects.9 A confirmatory randomized, sham-controlled multicenter US-based trial is currently underway. At present, the VIVEVE I trial remains the only published, large-scale, randomized, sham-controlled, blinded study of a radiofrequency-based treatment.
New emerging data support the efficacy and safety of this specific radiofrequency treatment in patients with mild to moderate urinary stress incontinence; further studies confirming these outcomes are anticipated. The Viveve system is approved in many countries for various conditions, including urinary incontinence (1 country), sexual function (17 countries), vaginal laxity (41 countries), and electrocoagulation and hemostasis (4 countries, including the United States).