Histologic and Clinical Changes in Vulvovaginal Tissue After Treatment With a Transcutaneous Temperature-Controlled Radiofrequency Device

Dermatol Surg. 2018 May;44(5):705-713. doi: 10.1097/DSS.0000000000001453.


Background: Although transcutaneous temperature-controlled radiofrequency (TTCRF) may effectively treat vulvovaginal laxity (VVL), atrophic vaginitis (AV), orgasmic dysfunction (OD), and stress urinary incontinence (SUI), there is a lack of histopathologic evidence to validate its use.

Objective: Evaluate clinical and histological changes induced by vulvovaginal TTCRF.

Materials and methods: This was a prospective, nonrandomized trial. Ten female subjects with mild-to-moderate VVL, with or without AV, OD, and/or SUI underwent 3 TTCRFs at 4-week intervals. Five subjects underwent pre- and post-treatment biopsies of the labia majora and vaginal canal for histology. Assessments were performed at baseline and Days 10, 30, 60, and 120.

Results: Investigator-rated VVL improved significantly from baseline to Day 10, with improvement maintained through Day 120 (p = .001 and .001, respectively). Sexual satisfaction improved significantly by Day 60 (p = .001). Improvement in AV reached significance at Day 120 (p = .048). Although OD and SUI improved steadily, the difference in improvement did not reach statistical significance. Histology revealed that post-treatment increases in collagen, elastin, vascularity, and small nerve fibers.

Conclusion: Transcutaneous temperature-controlled RF resulted in significant improvements in AV, VVL, and sexual satisfaction with milder improvements in OD and SUI. Post-treatment histology demonstrated neocollagenesis, neoelastogenesis, neoangiogenesis, and the first reported finding of TTCRF-related neurogenesis.

Publication types

  • Comparative Study

MeSH terms

  • Adult
  • Atrophy / therapy
  • Biopsy
  • Elastin / radiation effects
  • Female
  • Humans
  • Middle Aged
  • Patient Satisfaction*
  • Prospective Studies
  • Radio Waves*
  • Radiofrequency Therapy
  • Sexual Dysfunction, Physiological / therapy
  • Surveys and Questionnaires
  • Temperature
  • Treatment Outcome
  • Vagina / pathology
  • Vagina / radiation effects*
  • Vulva / pathology
  • Vulva / radiation effects*


  • Elastin