Aplicação de radiofrequência não ablativa transvaginal no tratamento da incontinência urinária e síndrome geniturinária da menopausa: seguimento de estudo clínico cego, controlado e randomizado

Abstract

Background: Genitourinary syndrome of menopause (GSM) encompasses signs and symptoms related to estrogen deficiency and significantly affects the quality of life of postmenopausal women. Urinary incontinence (UI) is one of the most prevalent and disabling conditions in this population, with negative effects on self-esteem, sexual function, and overall well-being. Due to limitations of hormonal therapy and contraindications to surgical treatment, energy-based therapies such as non-ablative transvaginal radiofrequency (NATRF) have emerged as minimally invasive alternatives. NATRF delivers controlled thermal energy to promote tissue regeneration through neocollagenesis and neoelastogenesis, potentially improving urinary and genital symptoms. Objective: To evaluate the efficacy of NATRF in improving UI and GSM symptoms in postmenopausal women at a 6-month follow-up. Secondary objectives were to compare intervention and control groups regarding voiding function, GSM symptoms, pelvic floor muscle (PFM) strength, quality of life, and to assess the safety of the procedure. Methods: This is a 6-month follow-up of a blinded, randomized, controlled clinical trial conducted at the gynecology outpatient clinic of the University of Caxias do Sul (UCS). Postmenopausal women with UI and GSM were randomly assigned to an intervention group (IG), which received three sessions of NATRF (45°C, four minutes per vaginal quadrant, at three-week intervals), or to a control group (CG), which underwent a sham procedure. All participants received standardized guidance on PFM exercises. Outcomes were assessed using validated questionnaires for UI and GSM, PFM strength evaluated by the Oxford scale and perineometry, and vaginal pH measurement. Multivariate models and standardized factor scores were used for statistical analysis. Results: At 6 months, the IG showed a statistically significant improvement in voiding-related domains (DIARY_URINARY factor; p = 0.025) and genitourinary symptoms (GSM factor; p = 0.008). No significant between-group differences were observed in quality-of-life scores (KHQ) or PFM strength (Oxford scale), although a clinically favorable trend toward the IG was noted. NATRF was safe and well tolerated, with no relevant adverse events reported. Conclusion: NATRF demonstrated therapeutic potential and a favorable safety profile for the treatment of UI and GSM, with significant improvement in urinary and genitourinary symptoms at 6-month follow-up. [resumo fornecido pelo autor]