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

Lasers Surg Med. 2016 Mar;48(3):254-9. doi: 10.1002/lsm.22450. Epub 2016 Jan 8.


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.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Cosmetic Techniques / instrumentation*
  • Female
  • Humans
  • Middle Aged
  • Patient Satisfaction
  • Prospective Studies
  • Radiofrequency Therapy*
  • Single-Blind Method
  • Treatment Outcome
  • Vulva / radiation effects*