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

ABSTRACT: 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.

SUBMITTER: Krychman M

PROVIDER: S-EPMC5865245 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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

Krychman Michael M Rowan Christopher G CG Allan Bruce B BB Durbin Scott S Yacoubian Ashley A Wilkerson Deborah D

Journal of women's health (2002) 20171128 3

<h4>Objective</h4>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).<h4>Materials and methods</h4>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 premen ...[more]

PMID: 29182498

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Dataset Information

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

Publications

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

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