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 vagina

SUBMITTER: Krychman M 

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

REPOSITORIES: biostudies-literature