Effect of Single-Session, Cryogen-Cooled Monopolar Radiofrequency Therapy on Sexual Function in Women with Vaginal Laxity: The VIVEVE I Trial

J Womens Health (Larchmt). 2018 Mar;27(3):297-304. doi: 10.1089/jwh.2017.6335. Epub 2017 Nov 28.


Objective: This subanalysis of the VIVEVE I trial aimed to evaluate the impact of cryogen-cooled monopolar radiofrequency (CMRF) therapy, for the treatment of vaginal laxity, on the domains of sexual function included in the Female Sexual Function Index (FSFI).

Materials and methods: The VIVEVE I clinical trial was prospective, randomized, single-blind, and Sham-controlled. Nine clinical study centers in Canada, Italy, Spain, and Japan were included. This subanalysis included premenopausal women with self-reported vaginal laxity who had ≥1 term vaginal delivery and a baseline FSFI total score ≤26.5, indicating sexual dysfunction. Enrolled subjects were randomized (2:1) to receive CMRF therapy [Active (90 J/cm2) vs. Sham (≤1 J/cm2)] delivered to the vaginal tissue. Independent analyses were conducted for each FSFI domain to evaluate both the mean change, as well as the clinically important change for Active- versus Sham-treated subjects at 6 months post-intervention.

Results: Subjects randomized to Active treatment (n = 73) had greater improvement than Sham subjects (n = 35) on all FSFI domains of sexual function at 6 months postintervention. The analysis of covariance change from baseline analyses showed statistically significant improvements, in favor of Active treatment, for sexual arousal (p = 0.004), lubrication (p = 0.04), and orgasm (p = 0.007). In addition, Active treatment was associated with clinically important and statistically significant improvements in sexual desire [Odds ratio (OR) = 3.01 (1.11-8.17)], arousal [OR = 2.73 (1.06-7.04)], and orgasm [OR = 2.58 (1.08-6.18)].

Conclusions: This subanalysis showed CMRF therapy is associated with statistically significant and clinically important improvements in sexual function in women with vaginal laxity. These findings provide the first randomized, placebo-controlled energy-based device evidence for functional improvements associated with a nonsurgical modality for a highly prevalent and undertreated condition.

Keywords: FSFI; FSFI domains; nonsurgical; radiofrequency therapy; sexual function; surface cooled; vaginal laxity; vaginal looseness.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Canada
  • Delivery, Obstetric / adverse effects*
  • Elasticity / physiology
  • Elasticity / radiation effects*
  • Female
  • Humans
  • Italy
  • Japan
  • Middle Aged
  • Personal Satisfaction
  • Premenopause*
  • Prospective Studies
  • Radiofrequency Therapy*
  • Sexual Dysfunction, Physiological / physiopathology
  • Sexual Dysfunction, Physiological / therapy*
  • Single-Blind Method
  • Spain
  • Surveys and Questionnaires
  • Treatment Outcome
  • Vagina / pathology
  • Vagina / physiopathology*