Vaginal Laser Therapy for the Management of Genitourinary Syndrome of Menopause of Breast Cancer Survivors: Double-blind Randomized Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- 10-centimeter Visual Analogue Scale assessing intensity of dyspareunia and dryness
研究概览
简要总结
This study evaluates the efficacy of vaginal CO2 laser therapy in breast cancer survivors with symptoms of Genitourinary Syndrome of Menopause. Half of participants will receive active laser therapy, while the other half placebo therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •breast cancer history
- •dyspareunia
排除标准
- •Active genital infection (i.e herpes, vaginitis)
- •Prolapse stage >=2
- •Underlying pathologies that could interfere with the protocol compliance
研究组 & 干预措施
Laser Group
Microablative Fractional CO2 Laser Therapy (The parameters that will be used are the following: 1) Power: 30 ή 40 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter from 1-3 depending on the treatment status, 5) D-pulse mode.)
干预措施: Microablative Fractional CO2 Laser Therapy (Device)
Placebo
Placebo therapy (The parameters that will be used are the following: 1) Power: 0.5 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter 1, 5) Smart-pulse mode.
干预措施: Microablative Fractional CO2 Laser Therapy (Device)
结局指标
主要结局
10-centimeter Visual Analogue Scale assessing intensity of dyspareunia and dryness
时间窗: Change from baseline at 1 month post-treatment
It is a straight line with 2 endpoints "0" and "10". Zero defines "no dyspareunia at all" and "no dryness at all" , while 10 "dyspareunia as bad as it could be" and "dryness as bad as it could be". Participants will draw a line at or between the 2 end points. The distance between zero and drawn line will define the intensity of dyspareunia and dryness
次要结局
- International Consultation on Incontinence Questionnaire Short Form(6 months)
- Urogenital Distress Inventory 6(6 months)
- Vaginal Health Index Score(6 months)
- Modified Sexual Quality of Life Questionnaire-Male(6 months)
- Patients Global Impression of Improvement(At 1-month post-treatment)
- 10-centimeter Visual Analogue Scale assessing intensity of itching, burning and dysuria(Change from baseline at 1 month post-treatment)
- King's Health Questionnaire (KHQ)(Change from baseline at 1 month post-treatment)
- Female Sexual Function Index(Change from baseline at 1 month post-treatment)
- Epithelial thickness(6 months)
- Collagen(6 months)
- 3 days voiding diary(Change from baseline at 1 month post-treatment)
- Day-to Day Impact of vaginal aging questionnaire (DIVA)(Change from baseline at 1 month post-treatment)
- Vaginal Maturation Value(6 months)
- Number of blood vessels(6 months)
- Size of blood vessels(6 months)
研究者
Themos Grigoriadis
Assistant Professor
National and Kapodistrian University of Athens