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

University of Cagliari

Status: Enrolling

Conditions: Genitourinary Syndrome of Menopause

Treatments: Device: Leonardo® Diode laser

Study type: Observational

Funder types: Other

Identifiers

NCT06503003

NP/2022/4057

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 45 to 73 years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Laser Therapy Group

Description:

Participants will receive non-ablative dual-wavelength diode laser therapy for Genitourinary Syndrome of Menopause (GSM). The intervention includes three monthly sessions using the Leonardo® Diode laser (Biolitec®) with wavelengths of 980 nm and 1470 nm. Each session lasts about 20 minutes and involves 8 pulses per centimeter along the vaginal canal. Local lidocaine gel is used as an anesthetic. Evaluations occur at baseline, 3 months, and 6 months post-treatment.

Treatment:

Device: Leonardo® Diode laser