Genitourinary Syndrome of Menopause
Conditions
Keywords
Genitourinary Syndrome of Menopause, Diode laser, Vaginal Atrophy, Menopause, Sexual Function
Brief 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.
Interventions
DEVICELeonardo® 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.
Sponsors
University of Cagliari
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 73 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vaginal Dryness | Baseline, 3 months, 6 months after the final laser treatment | 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 | Baseline, 3 months, and 6 months after the final laser treatment | 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) | Baseline, 3 months, and 6 months after the final laser treatment | 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) | Baseline, 3 months, and 6 months after the final laser treatment | 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. |
| Change in Sexual Function | Baseline, 3 months, and 6 months after the final laser treatment | 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. |
| Change in Sexual Quality of Life | Baseline, 3 months, and 6 months after the final laser treatment | 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. |
Countries
Italy
Contacts
Primary ContactStefano Angioni
Outcome results
None listed