Status:
RECRUITING
Non-ablative Diode Laser Therapy for Genitourinary Syndrome of Menopause: A Prospective Study on Efficacy, Safety, and Quality of Life and Sexuality Impact
Lead Sponsor:
University of Cagliari
Conditions:
Genitourinary Syndrome of Menopause
Eligibility:
FEMALE
45-73 years
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 S...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06503003
Start Date
September 1 2023
End Date
January 1 2025
Last Update
July 16 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Division of Gynecology and Obstetrics Department of Surgical Sciences, University of Cagliari, Cagliari, Italy
Cagliari, CA, Italy, 09042