Non-ablative Diode Laser Therapy for Genitourinary Syndrome of Menopause: A Prospective Study on Efficacy, Safety, and Quality of Life and Sexuality Impact

Launched by UNIVERSITY OF CAGLIARI · Jul 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for Genitourinary Syndrome of Menopause (GSM), which can cause uncomfortable symptoms like vaginal dryness and pain during sex in post-menopausal women. The researchers want to see if a non-invasive laser therapy can help alleviate these symptoms for women who have not found relief with hormone treatments. The trial will involve sexually active women between the ages of 45 and 73 who have not experienced their menstrual cycle for over a year and are currently dealing with at least one symptom of GSM.

Participants in the study will receive three sessions of laser therapy over three months and will have follow-up visits to check on their symptoms and overall well-being. They will also fill out questionnaires to share their experiences related to sexual function and quality of life. This study is important because it aims to provide evidence for a safe and effective non-hormonal treatment option for women struggling with GSM, especially those who cannot use or have not benefited from hormonal therapies.

Gender

FEMALE

Eligibility 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.