ஐ.எஸ்.எஸ்.என்: 2167-0420
Fernando M. Aznar Manas*, Jose Salas Molina
Background and Purpose: This study aims to evaluate the safety and efficacy of a focused, monopolar, 360° energy distribution radiofrequency (RF) device for non-invasive treatment of dyspareunia in menopausal women with genitourinary syndrome of menopause (GSM). Methods: Thirty-five postmenopausal women with severe dyspareunia and GSM, underwent three sessions of monopolar radiofrequency therapy delivered once a month. Participants were evaluated at baseline and 2 months after their last treatment. The primary outcome was determined by assessing the patient's satisfaction with sexual intercourse at the 2-month follow-up visit. Secondary outcomes included the Vaginal Maturation Index (VMI), Maturation Value (MV), Bachmann´s Vaginal Health Index (VHI), and vaginal pH measurement. Safety outcomes included monitoring any possible complications and adverse events, and patient discomfort was evaluated by the Visual Analogue Scale (VAS). Results: A total of 83.3% of women initially incapable of sexual intercourse due to severe dyspareunia, were able to fully engage in sexual intercourse without pain 2 months post-treatment. VMI and VHI increased significantly in all parameters for all subjects (P<0.01). The Bachmann´s Vaginal Health Index Score (VHI) improved significantly (P<0.01) by 11.2 points. The analysis of vaginal cells demonstrated complete vaginal restoration with the presence of vaginal Lactobacillus flora, a normal acidic vaginal pH, the absence of inflammatory cells, and even the presence of superficial vaginal epithelial cells in initially severely atrophic tissue. Ninety-eight percent of subjects reported mild to no discomfort during their last treatment. No serious side effects throughout the course of the study were reported. Conclusion: The present study demonstrates a positive effect of a focused monopolar RF device for non-invasive and non-hormonal vulvovaginal tissue restoration affected by severe GSM. The results indicate clinical improvement in severe dyspareunia as a bothersome symptom of GSM. The treatment is effective and safe with high patient satisfaction.