title: Short time efficacy and safety of focused monopolar radiofrequency device for labial laxity improvement-noninvasive labia tissue tightening. A prospective cohort study.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Health Studies, University of Split, Split, Croatia.
authors.forename: Ivan
authors.initials: I
authors.lastname: Fistonić
authors.affiliation: Teaching Institute of Public Health, Rijeka, Croatia.
authors.forename: Iva
authors.initials: I
authors.lastname: Sorta Bilajac Turina
authors.affiliation: Department of Ob/Gyn, University Hospital Merkur, Zagreb, Croatia.
authors.forename: Nikola
authors.initials: N
authors.lastname: Fistonić
authors.affiliation: Department of Ob/Gyn, University Hospital Sveti Duh, Zagreb, Croatia.
authors.forename: Ingrid
authors.initials: I
authors.lastname: Marton
mesh_terms: D000328:Adult; D003357:Cosmetic Techniques / Q000295:instrumentation*; D005260:Female; D006801:Humans; D008875:Middle Aged; D017060:Patient Satisfaction; D011446:Prospective Studies; D000078702:Radiofrequency Therapy; D016037:Single-Blind Method; D016896:Treatment Outcome; D014844:Vulva / Q000528:radiation effects*
keywords: radio-frequency; vulvar laxity