Non-ablative Diode Laser Therapy for Genitourinary Syndrome of Menopause: A Prospective Study on Efficacy, Safety, and Quality of Life and Sexuality Impact
NCT Number: NCT06503003
Acronym: GSMLASER
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Genitourinary Syndrome of Menopause
Interventions: DEVICE: Leonardo® Diode laser
Sponsor: University of Cagliari
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-01
Completion Date: 2025-01-01
Locations: Division of Gynecology and Obstetrics Department of Surgical Sciences, University of Cagliari, Cagliari, Italy, Cagliari, CA, 09042, Italy

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.

Primary Outcome Measures: 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., 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., Baseline, 3 months, and 6 months after the final laser treatment|Change in Pain During Intercourse (Dyspareunia), Measurement of the change in pain during intercourse scores using the Visual Analog Scale (VAS). The Visual Analog Scale ranges from 0 to 10, with higher scores indicating worse pain during intercourse., Baseline, 3 months, and 6 months after the final laser treatment|Change in Vaginal Health Index Score (VHIS), Measurement of the change in the Vaginal Health Index Score (VHIS), which examines five aspects of vaginal health: elasticity, fluid volume, pH, epithelial integrity, and moisture. Each component is rated on a scale from 1 (indicating severe vaginal atrophy) to 5 (indicating no clinical signs of vaginal atrophy), with a total score below 15 confirming vaginal atrophy. Higher scores indicate better vaginal health., Baseline, 3 months, and 6 months after the final laser treatment|Change in Sexual Function, Measurement of the change in sexual function scores using the Female Sexual Function Index-6 (FSFI-6). The FSFI-6 is a six-item version of the Female Sexual Function Index-19 (FSFI-19) and includes one item from each original domain: desire, arousal, lubrication, orgasm, satisfaction, and pain. Responses range from 0 (no sexual activity) to 5 (optimal function), with higher scores indicating better sexual function. An FSFI-6 score of 19.0 or less indicates sexual dysfunction., Baseline, 3 months, and 6 months after the final laser treatment|Change in Sexual Quality of Life, Measurement of the change in scores on the Sexual Quality of Life-Female (SQOL-F) questionnaire. The SQOL-F questionnaire consists of 18 items that assess sexual self-esteem, emotional well-being, and relationship issues. Scores range from 18 to 108, with higher scores indicating better sexual quality of life., Baseline, 3 months, and 6 months after the final laser treatment|Change in Sexual Function, Measurement of the change in sexual function scores using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). The PISQ-12 is a 12-item questionnaire used to evaluate sexual function in patients suffering from urinary incontinence or pelvic organ prolapse. It explores three domains: behavioral-emotive, physical, and partner-related, scored on a 5-point Likert scale from 0 (always) to 4 (never), with reverse scoring for the first four items. Higher scores indicate better sexual function., Baseline, 3 months, and 6 months after the final laser treatment