Short time efficacy and safety of focused monopolar radiofrequency device for labial laxity improvement—noninvasive labia tissue tightening. A prospective cohort study

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. Lasers Surg. Med. 48:254–259, 2016. © 2016 Wiley Periodicals, Inc.