Abstract
Objective: Genitourinary syndrome of menopause (GSM) is a prevalent disorder that can negatively impact the overall health, sexual function, and quality of life of affected women; however, available data do not support specific treatment protocols. A novel product enables the noninvasive transdermal administration of carboxytherapy with a topical gel (CO2Lift®, Lumisque, Inc.; Weston, FL). The following randomized, placebo-controlled pilot study assessed the safety and efficacy of the transdermal carboxytherapy gel for treating GSM-related vulvovaginal changes. Methods: Menopausal or postmenopausal women 40 to 70 years old with signs or symptoms of vulvovaginal atrophy and Female Sexual Dysfunction were randomized to receive topical carboxytherapy gel (n=40) or placebo gel (n=10) in a randomized, double-blind fashion. The assigned treatments were placed into the vagina and on the vulva for 45 minutes before removal. Treatment was applied daily for 5 days, stopped for 2 days, then continued for 5 additional days. Subjects completed four validated pre- and posttreatment questionnaires to assess female sexual function, sexual health, and genital self-image. Additionally, control (n=10) and treatment subjects (n=10) were randomized to undergo 3 mm pre- and posttreatment punch biopsies of vulva and vaginal tissue. Results: Overall, carboxytherapy-treated subjects achieved significant improvements in Female Sexual Function Index scores with strong positive correlations between sexual desire and arousal, arousal and sexual satisfaction, and sexual satisfaction and desire. The Day-to-Day Impact of Vaginal Aging Questionnaire results demonstrated a significant difference in mean pre- and posttreatment values for each assessment among subjects receiving topical carboxytherapy. Biopsy improvements included hyperplasia of the keratinized squamous epithelium, discrete hyperplasia of the basal layer and neovascularization, and increased thickness of mucous squamous epithelium. There were no adverse events. Conclusion: Transdermal carboxytherapy represents a safe, noninvasive means of treating the genitourinary syndrome of menopause symptoms and is suitable for home use. Additional research on this treatment is warranted.
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