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
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 45
Maximum Age: 73
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Division of Gynecology and Obstetrics Department of Surgical Sciences, University of Cagliari, Cagliari, Italy
RECRUITING
Cagliari
Contact Information
Primary
Stefano Angioni
sangioni@yahoo.it
+3907051093399
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2025-01-01
Participants
Target number of participants: 50
Treatments
Laser Therapy Group
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.
Related Therapeutic Areas
Sponsors
Leads: University of Cagliari

This content was sourced from clinicaltrials.gov