Evaluation of the Safety and Efficacy of a Novel Radiofrequency Device for Vaginal Treatment.

INTRODUCTION

Vaginal laxity and atrophy are caused mainly by aging and vaginal childbirth, which lead to a loss of strength and flexibility within the vaginal wall. As a result, women may experience vaginal, pelvic, sexual and urinary symptoms that significantly affect their quality of life.

OBJECTIVE

The aim of this study was to evaluate the safety and efficacy of a novel radiofrequency (RF) device for internal and external vaginal treatment.

METHODS

Thirty women who had been diagnosed with symptoms of vaginal laxity and pelvic relaxation received a single treatment that consisted of continuous RF in the internal genitalia and continuous RF followed by fractional RF in the external vulva. Three different treatment conditions were examined. The results were evaluated by questionnaires and photos at two months post-treatment compared to baseline.

RESULTS

For all parameters that were scored in the questionnaires, including vaginal symptoms, sexual matters, quality of life, pelvic floor impact and Stress Urinary Incontinence, significant improvements were found at a 2-month follow-up, compared to baseline (p<0.001). No significant or unexpected adverse events were noted.

CONCLUSIONS

The present results suggest that this novel RF-based device with continuous and fractional RF technologies is useful, safe and effective for treating vaginal relaxation and atrophy symptoms.