Radiofrequency Non-ablative Treatment for Genitourinary Syndrome of Menopause with Kinesiotherapy

What this Trial Is About

This research aims to evaluate the use of a non-ablative radiofrequency device in women experiencing Genitourinary Syndrome of Menopause, which causes symptoms like vulvovaginal atrophy and urinary tract issues. The study focuses on women in menopause who have clinical complaints related to this syndrome. Participants will be treated and assessed to understand the impact of radiofrequency treatment on their condition over time. Participants receive five weekly sessions of radiofrequency treatment using the CAPENERGY device, which delivers energy through an intra-vaginal electrode and a coupling electrode placed on the back. The treatment maintains a temperature of 41°C for 2 minutes on the anterior vaginal wall and 2 minutes on the posterior wall in each session. In addition to radiofrequency, all participants undergo kinesiotherapy once a week for five sessions, including guidance on pelvic floor muscle contraction. During the study, participants are regularly evaluated by a physical therapist through vaginal pH tests, cell maturation index exams, and questionnaires assessing quality of life, urinary incontinence, sexual function, and genital self-image. These assessments occur at one week, one month, and then every three months up to one year post-treatment. The trial is randomized and double-blinded, with safety and treatment effects monitored throughout the year-long follow-up period.

Radiofrequency Non-ablative in the Treatment of Genitourinary Syndrome of Menopause