Device-based treatment for vaginal wellness.

Abstract

Genitourinary syndrome of menopause (GSM), encompassing the disorders of atrophic vaginitis, urinary incontinence, and pelvic prolapse, affects the majority of postmenopausal women, as well as patients who are undergoing breast cancer treatement, post-ovarectomy, post-radiation, and breast-feeding. There is a need for better treatment options for these common conditions that adversely affect physical function and quality of life and that are often underserved by existing options. Lasers have been used to treat genitourinary tissue for over 40 years, and over the past decade, several lasers and radiofrequency devices have been developed and clinically tested for the treatment of GSM, with an accumulating body of evidence demonstrating their safety and efficacy. Fractional lasers, including carbon dioxide, erbium: YAG and hybrid technologies, as well as monopolar radiofrequency devices, work by resurfacing and/or stimulating via heat the vaginal lining resulting in a re-epithelialization, neovascularization, and remodeling of the vaginal tissue from an atrophic postmenopausal state to a thickened, glycogen-rich and well-vascularized state similar to premenopausal vaginal lining. These changes are correlated clinically with improved function on a variety of validated vaginal health scales and urinary incontinence tests. Currently cleared for general application to genitourinary tissue, clinical trials are underway for FDA clearance or approval for specific GSM indications.