Non-ablative Diode Laser Therapy for Genitourinary Syndrome of Menopause: A Prospective Study on Efficacy, Safety, and Quality of Life and Sexuality Impact
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Sexual Quality of Life
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 73 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Sexual Quality of Life
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Stefano Angioni
Professor
University of Cagliari