Safety, tolerability and short-term efficacy of transvaginal fractional bipolar radiofrequency therapy for symptoms of stress and or mixed incontinence in conjunction with genitourinary syndrome of menopause.

Abstract

Radiofrequency (RF) energy application stimulates collagen and elastin remodeling to restore the elasticity, and moisture of the superficial vaginal mucosa. This is the first study to report on the use of microneedling to deliver RF energy to the vaginal canal. Microneedling increases the response of the collagen contraction and neocollagenesis in deeper layers of tissue, thus increasing the support to the surface. The novel intravaginal microneedling device used in this study allows penetration of the needles to 1, 2, or 3 mm. A prospective study to evaluate the safety and short-term outcome of a single fractional RF treatment of the vaginal canal in a series of women with coexistent stress or mixed incontinence (MUI) and genitourinary syndrome of menopause (GSM). Twenty women who had symptoms of SUI and or MUI in conjunction with GSM were given a single vaginal treatment that consisted of fractional bipolar RF energy using the EmpowerRF platform with the Morpheus8V applicator (InMode). RF energy was delivered into the vaginal walls via 24 microneedles, at a depth of 1, 2, and 3 mm. Outcomes were evaluated by "cough" stress test, questionnaires (MESA SI, MESA UI, iQoL, UDI-6) and evaluation of vaginal tissue through the VHI scale at 1-, 3-, and 6-months post-treatment compared to baseline. Biopsies were performed at baseline and 3-months on five patients for histological reference and tissue evaluation. Eight out of eight outcomes measured from baseline to 6-months post-treatment showed improvement. The parameters scored in the questionnaires including frequency, urgency, nocturia, urge incontinence, and stress incontinence showed significant improvement in all areas at the 1-, 3-, and 6-month follow-up sessions compared to baseline. The results showed evidence that fractional RF energy delivered vaginally is safe, well tolerated, and provide short term improvement of SUI and or MUI in conjunction with GSM.