Effect of Single-Treatment, Surface-Cooled Radiofrequency Therapy on Vaginal Laxity and Female Sexual Function: The VIVEVE I Randomized Controlled Trial

Michael Krychman, Christopher G. Rowan, Bruce B. Allan, Leonard Derogatis, Scott Durbin, Ashley Yacoubian, Deborah Wilkerson

Research output: Contribution to journalArticle

Abstract

Introduction Vaginal laxity is a highly prevalent and undertreated medical condition. Aim To evaluate the efficacy and safety of surface-cooled, monopolar radiofrequency (RFc) therapy for the treatment of vaginal laxity in the VIVEVE I trial. Methods The VIVEVE I trial was a prospective, randomized, single-blinded, and sham-controlled study. Nine study centers in Canada, Italy, Spain, and Japan participated. Women presenting with vaginal laxity were screened and informed consent was obtained. Major study inclusion criteria were premenopausal status, age at least 18 years, at least one full-term vaginal delivery, and normal genito-pelvic examination results. Enrolled subjects were randomized (2:1) to receive RFc therapy (Active [90 J/cm2] vs Sham [1 J/cm2], respectively) delivered to the vaginal tissue. Main Outcome Measures The primary efficacy outcome was the proportion of randomized subjects reporting “no vaginal laxity” (Active vs Sham) at 6 months postintervention, which was assessed using the Vaginal Laxity Questionnaire. Treatment-emergent adverse events were evaluated in all treated subjects. Secondary efficacy end points included change on the Female Sexual Function Index (FSFI) and the revised Female Sexual Distress Scale (FSDS-R). Results No vaginal laxity was achieved by 43.5% and 19.6% (P = .002) in the Active and Sham groups, respectively. Differences in FSFI and FSDS-R total scores (Active vs Sham) were 1.8 (P = .031) and −2.42 (P = .056), respectively, in favor of Active treatment. Treatment-emergent adverse events were reported by 11.1% and 12.3% of subjects in the Active and Sham arms, respectively. Conclusion The VIVEVE I trial is the first randomized, controlled, blinded, clinical study of RFc for the treatment of vaginal laxity. A single treatment of RFc therapy was found to be safe and associated with both improved vaginal laxity and improved sexual function. The results from this trial support the use of a novel non-surgical therapy for vaginal laxity, a prevalent and undertreated condition.

Original languageEnglish (US)
Pages (from-to)215-225
Number of pages11
JournalJournal of Sexual Medicine
Volume14
Issue number2
DOIs
StatePublished - Feb 1 2017
Externally publishedYes

Keywords

  • Non-Surgical
  • Radiofrequency Therapy
  • Sexual Function
  • Surface Cooled
  • Vaginal Laxity
  • Vaginal Looseness

ASJC Scopus subject areas

  • Medicine(all)
  • Reproductive Medicine
  • Obstetrics and Gynecology
  • Urology

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