Non-ablative Diode Laser Therapy for Genitourinary Syndrome of Menopause: A Prospective Study on Efficacy, Safety, and Quality of Life and Sexuality Impact

The goal of this observational study is to evaluate the efficacy, safety, and impact on quality of life and sexuality of non-ablative dual-wavelength diode laser treatments in managing Genitourinary Syndrome of Menopause (GSM) in sexually active post-menopausal women who cannot use or have not benefited from local estrogen-based therapies. The main questions it aims to answer are: Does non-ablative dual-wavelength diode laser therapy improve vaginal dryness, burning sensation, and dyspareunia in post-menopausal women? What is the impact of this therapy on the vaginal health index and sexual function? Researchers will compare the laser-treated group to their baseline measurements to see if non-ablative dual-wavelength diode laser therapy effectively treats GSM. Participants will: Undergo three monthly sessions of dual-wavelength diode laser therapy. Participate in follow-up evaluations at three and six months post-treatment. Complete self-assessments of GSM symptoms and questionnaires evaluating sexual function and quality of life at each follow-up. This study aims to provide preliminary evidence that non-ablative dual-wavelength diode laser therapy is a safe and effective non-hormonal treatment for GSM, addressing a gap in existing treatments for women who cannot use or have not benefited from hormonal therapies.

NCT Number	NCT06503003
Lead Sponsor	University of Cagliari
Conditions	Genitourinary Syndrome of Menopause
Enrollment	50 participants
Start Date	2023-09-01
Primary Completion	2024-12-01 (estimated)
Study Completion	2025-01-01 (estimated)
Updated on ClinicalTrials.gov	2024-07-16