Study of the Efficiency and Safety of Low-Intensity Neodymium Laser Radiation With a Nanosecond Pulse Duration for Treatment of the Vaginal Walls Atrophic Changes

What this Trial Is About

This research aims to study the changes in the vaginal wall after treatment with low-intensity nanosecond neodymium laser radiation at a wavelength of 1064 nm in postmenopausal women. The study evaluates and compares laser treatment, topical hormone therapy, and no treatment groups to assess improvements in vaginal wall condition. Up to 100 participants with vaginal atrophy and 20 without atrophy will be enrolled, with the primary goal of observing at least a 30% improvement after laser treatment compared to initial conditions and other treatments. Participants will be divided into three groups: one receiving laser treatment with the "Magic Max" laser in three procedures spaced 4-6 weeks apart, another receiving topical hormone therapy with estriol suppositories daily for two weeks followed by maintenance use twice weekly, and a third group with no treatment. Laser treatment involves three stages targeting the vaginal canal, vulva, and paraurethral area using different handpieces, performed without anesthesia. All groups will undergo the same schedule of tests and assessments at similar time intervals. Throughout the study, participants will attend multiple visits for clinical and specialized tests, including blood and urine analysis, vaginal smears, colposcopy, ultrasound, perineometry, optical coherence tomography, biopsy, and quality of life questionnaires. Follow-up visits occur at 1, 3, and 6 months after treatment completion to monitor changes. Researchers will measure outcomes such as vaginal health index scores, vaginal wall thickness, blood flow in vaginal vessels, and tissue changes. Safety and adherence to protocols will also be monitored during the study period ending in 2025.

Treatment of Vaginal Atrophy With Low Intensity Nanosecond Neodymium Laser