A Randomized Controlled Pilot Trial Evaluating the Efficacy of Intravaginal and Extravaginal K-Laser Therapy as a Personalized Non-Hormonal Treatment for Genitourinary Syndrome of Menopause

Abstract

Background/Objectives: Genitourinary Syndrome of Menopause (GSM) negatively affects quality of life in postmenopausal women, causing sexual dysfunction, vaginal atrophy, and pelvic discomfort. Personalized medicine highlights the need for individualized, non-hormonal therapeutic options for women with contraindications to or preferences against hormonal treatment. Non-hormonal therapies, such as laser treatments, have emerged as potential alternatives, but evidence comparing intravaginal and extravaginal K-Laser therapy remains limited. This study aimed to evaluate the efficacy of intravaginal and extravaginal K-Laser therapy on the symptoms of Genitourinary Syndrome of Menopause (GSM) in postmenopausal women. Methods: In this single-center, randomized, single-blind, placebo-controlled trial, 57 postmenopausal women were randomly assigned to receive either intravaginal and extravaginal K-Laser Cube Plus 30 therapy (n = 36) or a simulated control treatment (n = 21). The primary outcome was sexual function, measured by the Female Sexual Function Index (FSFI). Secondary outcomes included vaginal pH and pelvic floor muscle function assessed via the PERFECT protocol. Outcomes were assessed at baseline and after 6 weeks. Results: Sixty-seven women were enrolled, and ten were lost to follow-up. The treatment group showed significant improvements over the control group in FSFI (mean difference = 6.38; p < 0.001), PERFECT protocol scores (mean difference = 0.78; p = 0.004), CPPQ-Mohedo (mean difference = 5.44; p < 0.001), and Menopause Rating Scale (mean difference = 6.50; p = 0.017). Significant reductions were also observed in vaginal dryness, vulvar dystrophy, and atrophy (p < 0.001). Conclusions: Intravaginal and extravaginal K-Laser therapy appears to be a safe and effective non-hormonal treatment for GSM and may support personalized management strategies. However, further well-designed randomized clinical trials with larger samples, longer follow-up of both laser-treated and control groups, and objective outcome measures are needed to provide higher-quality evidence regarding efficacy and identify the patients most likely to benefit.