Use of radiofrequency ablation of the vaginal canal for genitourinary syndrome of menopause.

Abstract

Genitourinary syndrome of menopause (GSM) is a prevalent condition with a constellation of symptoms including burning, dryness, dyspareunia, and irritative lower urinary tract symptoms that result from vulvovaginal atrophic changes. Though hormonal therapy is a mainstay of treatment in GSM, some patients may pursue nonhormonal therapies. To determine the efficacy of radiofrequency ablation of the vaginal canal with the MorpheusV applicator in reducing the symptoms of GSM. We conducted a multicenter prospective case series of women with GSM as confirmed by Vaginal Health Index Score (VHIS). Subjects received 3 treatments of radiofrequency ablation ~4weeks apart with follow-up to 6-month posttreatment. The primary endpoint was VHIS at 6-month posttreatment. Secondary endpoints were VHIS at 3 months, Visual analog scale (VAS) pain with each treatment, 3- and 6-month measurements of urogenital distress inventory-6 (UDI-6), and female sexual function index (FSFI) questionnaires. From 2021 to 2023, 71 women were enrolled in the study with 51 followed to the 6-month follow-up time point. Treatments were found to be low in VAS pain score with mean values of 2.13 ± 2.1, 2.55 ± 2.38, and 2.18 ± 2.14 at treatments 1, 2, and 3 respectively. An improvement in VHIS score was seen from baseline to 3 months after the last treatment (15.00 ± 5.37 vs. 19.62 ± 4.44) and sustained at 6 months (20.23 ± 4.12) (P < .001). Significant improvements in both UDI-6 and FSFI were also noted. Between baseline and 6 months after treatment (FSFI: 18.81 ± 9.57 vs. 22.81 ± 10.34, P < 0.001; UDI-6: 39.58 ± 15.98 vs. 22.42 ± 14.03, P < 0.001). No adverse events were encountered by any subject during this study. A therapy that is safe and effective in the treatment of both GSM and lower urinary tract symptoms without the use of hormonal methods is clinically impactful for the many patients who cannot receive or do not desire to receive these medications. Strengths of this study include the utilization of 3 treatment sessions, with follow-up of subjects to 6-month posttreatment with a comprehensive assessment of patient symptoms. Limitations include the unblinded nature of the study and the lack of a comparator group. The data from this study suggests that radiofrequency ablation of the vaginal canal by the MorpheusV applicator is a safe and effective intervention for GSM. It also shows subjective improvements in stress urinary incontinence, urge urinary incontinence, and sexual function.