Non-ablative laser therapy for menopause-related vaginal issues
Non-ablative Diode Laser Therapy for Genitourinary Syndrome of Menopause: A Prospective Study on Efficacy, Safety, and Quality of Life and Sexuality Impact
This study is testing if a new laser treatment can help post-menopausal women with vaginal dryness and discomfort during sex who haven't found relief with hormone therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 45 Years to 73 Years |
| Sex | Female |
| Sponsor | University of Cagliari Academic / other |
| Locations | 1 site (Cagliari, CA) |
| Trial ID | NCT06503003 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the efficacy and safety of non-ablative dual-wavelength diode laser therapy in treating Genitourinary Syndrome of Menopause (GSM) in sexually active post-menopausal women who have not benefited from estrogen therapies. Participants will undergo three monthly laser treatment sessions and will be assessed for improvements in symptoms such as vaginal dryness and dyspareunia, as well as overall quality of life and sexual function. The study aims to compare the outcomes of the laser-treated group against their baseline measurements to determine the therapy's effectiveness.
Who should consider this trial
Good fit: Ideal candidates are sexually active post-menopausal women aged 45-73 experiencing symptoms of GSM who have not used lubricants or hormonal therapy in the past six months.
Not a fit: Patients with untreated cancers, severe health conditions, or active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a non-hormonal treatment option for women suffering from GSM, improving their quality of life and sexual health.
How similar studies have performed: While there is limited data on this specific laser approach, similar non-hormonal treatments for GSM have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cagliari, CA
- Division of Gynecology and Obstetrics Department of Surgical Sciences, University of Cagliari, Cagliari, Italy — Cagliari, Ca, Italy (Recruiting)
Study contacts
- Principal investigator: Stefano Angioni — University of Cagliari
- Study coordinator: Stefano Angioni
- Email: sangioni@yahoo.it
- Phone: +3907051093399
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.