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

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.

Inclusion Criteria:

• Post-menopausal women aged 45-73 years.
• Sexually active.
• Experiencing physiological amenorrhea for more than 12 months.
• Exhibiting at least one symptom of Genitourinary Syndrome of Menopause (GSM).
• Not using lubricants or hormonal therapy in the previous 6 months.
• Able to provide written informed consent.

Exclusion Criteria:

• Untreated uterine or vulvovaginal cancers.
• Pacemaker or other implanted electrode carriers.
• Severe multi-organ or neurological diseases.
• Active sexually transmitted infections.
• Moderate to severe uterine prolapse.
• Active urinary tract infections.
• Acute or chronic dermatological conditions in the vulvar or vaginal area.
• Active genital herpes.
• Active high-risk Human Papillomavirus (HPV).
• Ischemic tissues, unhealed wounds, sores, or undiagnosed mucosal or epithelial alterations.
• Recent unhealed invasive or ablative surgeries.
• Bleeding disorders or anticoagulant therapy.
• Immunodeficiencies.
• Uncontrolled diabetes.