Actively Recruiting
Non-ablative Diode Laser Therapy for Genitourinary Syndrome of Menopause: A Prospective Study on Efficacy, Safety, and Quality of Life and Sexuality Impact
Led by University of Cagliari · Updated on 2024-07-16
50
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Non-ablative Diode Laser Therapy for Genitourinary Syndrome of Menopause: A Prospective Study on Efficacy, Safety, and Quality of Life and Sexuality Impact
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Post-menopausal women aged 45-73 years
- Sexually active
- Physiological amenorrhea for more than 12 months
- At least one symptom of Genitourinary Syndrome of Menopause (GSM)
- No use of lubricants or hormonal therapy in the previous 6 months
- Able to provide written informed consent
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Division of Gynecology and Obstetrics Department of Surgical Sciences, University of Cagliari, Cagliari, Italy
Cagliari, CA, Italy, 09042
Actively Recruiting
Research Team
S
Stefano Angioni
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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