NCT06503003

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: University of Cagliari · Academic / Other
• Sex: Female
• Age: 45 Years – 73 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Genitourinary Syndrome of Menopause

Interventions

Type	Name	Description
DEVICE	Leonardo® Diode laser	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.

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-12-01
• Completion: 2025-01-01
• First posted: 2024-07-16
• Last updated: 2024-07-16

Locations

1 site across 1 country: Italy