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.
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).
Untreated uterine or vulvovaginal cancers.
Pacemaker or other implanted electrode carriers.
Severe multi-organ or neurological diseases.
Active sexually transmitted infections.
The study population consists of post-menopausal women aged 45-73 years who are experiencing symptoms of Genitourinary Syndrome of Menopause (GSM). These women are sexually active and have experienced physiological amenorrhea for more than 12 months. The participants have not used lubricants or hormonal therapy in the previous six months. The study targets those who cannot use or have not benefited from local estrogen-based therapies.
Cohort
Prospective
Leonardo® Diode laser
DeviceThe 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.
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.
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.
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.
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.
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