Non-ablative Diode Laser Therapy for Genitourinary Syndrome of Menopause: A Prospective Study on Efficacy, Safety, and Quality of Life and Sexuality Impact
- Conditions
- Genitourinary Syndrome of Menopause
- Interventions
- Device: Leonardo® Diode laser
- Registration Number
- NCT06503003
- Lead Sponsor
- University of Cagliari
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 50
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Laser Therapy Group Leonardo® Diode laser 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.
- Primary Outcome Measures
Name Time Method 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.
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 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 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 Sexual Function Baseline, 3 months, and 6 months after the final laser treatment 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Division of Gynecology and Obstetrics Department of Surgical Sciences, University of Cagliari, Cagliari, Italy
🇮🇹Cagliari, CA, Italy