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

University of Cagliari50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Genitourinary Syndrome of Menopause

Interventions

The intervention involves non-ablative dual-wavelength diode laser therapy for treating Genitourinary Syndrome of Menopause (GSM). This includes three monthly sessions of the Leonardo® Diode laser (Biolitec®), with wavelengths of 980 nm and 1470 nm, delivering 8 pulses per centimeter along the vaginal canal, using local lidocaine gel as an anesthetic. Evaluations are conducted at baseline, 3 months, and 6 months post-treatment.

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 73 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Vaginal Dryness

Measurement of the change in vaginal dryness scores using the Visual Analog Scale (VAS). The Visual Analog Scale ranges from 0 to 10, with higher scores indicating worse vaginal dryness.

Time frame: Baseline, 3 months, 6 months after the final laser treatment

Change in Burning Sensation

Measurement of the change in burning sensation scores using the Visual Analog Scale (VAS). The Visual Analog Scale ranges from 0 to 10, with higher scores indicating worse burning sensation.