Background and objective: To evaluate safety and efficacy of focused monopolar radio frequency (RF) device for non-invasive labia tissue tightening and improvement of labial laxity.
Methods: This prospective cohort study participants were 17 female subjects aged between 27 and 56 years with lax skin at the labia area. All subjects received four consecutive treatments at 7-day intervals with RF device (Exilis Protege IntimaR, BTL Industries Inc., Boston, MA). The primary efficacy outcome measure was defined as one or more point improvement on 1-4 scale for vulva appearance determined by three blinded evaluators. Digital photographs were taken at the baseline and 1 month after the last treatment. Sexual gratification was assessed with Female Sexual Functioning Index (FSFI) and patient discomfort by Visual Analogue Scale (VAS).
Results: An average 2.9 (of maximum 4) points improvement rate in vulvar appearance was observed (P < 0.01). Mean of the total FSFI score enhanced from initial 75-87% (P < 0.001). Resultant 4.7 (18%) points increase was achieved. Ninety four percent of subjects reported mild to none discomfort during the treatment. No adverse events during the study course were reported.
Conclusion: The present study demonstrates the positive effect of focused monopolar RF device for non-invasive labia tissue tightening. The treatment is effective and safe with high patient satisfaction.
Keywords: radio-frequency; vulvar laxity.
© 2016 Wiley Periodicals, Inc.