Transcutaneous Temperature-controlled Radiofrequency for Vaginal Rejuvenation.

Abstract

Background: Vaginal laxity and sexual dysfunction are commonly experienced by women, but are typically stigmatized and considered inappropriate to discuss openly. This study was designed to assess the effectiveness and safety of transcutaneous temperature-controlled radiofrequency (TTCRF), in addressing these concerns. The study used a single-blinded randomized sham-control design.

Aims and objectives: The aim was to study the role of TTCRF for vaginal rejuvenation using subjective and objective measurements.

Materials and methods: Two hundred parous women were randomly assigned to either a treatment group (n = 110) or a sham group (n = 90). Participants who were between 35 and 55 years of age and reported complaints of vaginal laxity, as well as those who presented symptoms such as vaginal flatus or sexual issues, were included. The treatment group was administered TTCRF therapy, whereas the sham group had a placebo procedure to ensure blinding was maintained. The outcome measures included subjective assessments, such as the Female Sexual Function Index (FSFI), the Vaginal Laxity Questionnaire (VLQ), the Vaginal Flatus Score (VFS), and the Vaginal Laxity and Bother Score (VLBS), as well as objective measurements, such as the Modified Oxford Score (MOS) and the Genital Hiatus (GH) questionnaire.

Results: Baseline characteristics were comparable between the groups. Significant improvements in FSFI, VLQ, and VLBS were noted in the treatment group compared to sham at 1 month, 3 months, and 6 months. The MOS improvements did not reach statistical significance, suggesting potential limitations in its use as an objective measure. VFS showed improvement in both the groups, indicating a potential placebo effect. No significant changes were observed in GH. Adverse events were mild and transient, with no serious incidents reported.

Conclusion: Despite societal taboos, TTCRF demonstrated notable improvements in subjective measures of vaginal laxity and sexual dysfunction over a 6-month period. The safety and outpatient feasibility of TTCRF were established. The findings contribute to understanding the role of TTCRF in managing these sensitive concerns among women.