Efficacy of a Mixed Wavelength Laser for Vaginal Health in Postmenopausal Women: A Randomized Controlled Trial

Juan Salinas Pena,1,* Sara Tameish,1,* Carmen Guilarte Calzada,2 Pere Cavallé Busquets1 1Department of Obstetrics & Gynecology, Hospital Universitari Sant Joan de Reus, Reus, Spain; 2Department of Pathology, Hospital Universitari Sant Joan de Reus. Universitat Rovira I Virgili, Reus, Spain*These authors contributed equally to this workCorrespondence: Juan Salinas Pena, Hospital Universitari Sant Joan de Reus, Avinguda del Doctor Josep Laporte, 2, Reus, Tarragona, 43204, Spain, Email [email protected]: Genitourinary syndrome of menopause (GSM) is a chronic and progressive condition. The adverse events (AEs) and contraindications of hormonal therapy have generated interest in vaginal laser treatment. The non-ablative wavelength 1540 nm (GaAs) in this mixed laser synergistically enhances the 10,600 nm (CO2) effect, providing a deeper hyperthermic stimulation of collagen and elastin without damaging the superficial layers. This results in fewer AEs, and reverses vaginal atrophy (VA) while reducing the 10,600 nm laser power to 5W. The aim of the study is to evaluate the efficacy and safety of a mixed-wavelength laser in alleviating GSM symptoms compared to sham.Patients and Methods: A randomized single-blind sham-controlled trial was conducted. 31 postmenopausal women with Vaginal Maturation Value (VMV < 50%) were randomized into laser or sham intervention groups, receiving three monthly treatments. VMV, vaginal pH, and GSM symptoms severity were measured at 3- and 9-months post-intervention, and AE were assessed.Results: 27 patients completed the study; 14 were randomly assigned to the laser and 13 to the sham group. At 3 months, VMV improved by 12.4% compared to the sham group (P= 0.033), indicating a significant reversal of VA and a significant patient global improvement (P=0.030). At 9 months, dyspareunia decreased significantly (P = 0.049), while other symptoms and patient satisfaction demonstrated a significant improvement trend. However, VMV in the laser group returned to baseline values. Vaginal pH remained unchanged. The laser intervention was well tolerated, with mild and self-limited AEs.Conclusion: The mixed wavelength laser enables a reduction of 10,600 nm laser power, enhancing its safety profile while achieving promising outcomes in GSM. It is a safe, well-tolerated, and effective alternative for GSM treatment when conventional therapies fail. Further studies with larger samples, varied settings, and extended follow-up are needed to assess its long-term efficacy and side effects.Keywords: vaginal rejuvenation, vaginal atrophy, genitourinary syndrome of menopause, hybrid laser, 1,540 nm, non-ablative laser