The Clinical, Histopathological, Cytological and Microbiological Efficacy of the Micro-ablative Fractional CO2 Laser : A Double-blind Randomized Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 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 clinical, histopathological, cytological and microbiological efficacy of Microablative Fractional CO2 laser intravaginally administered in postmenopausal women with Genitourinary Syndrome of Menopause. Half participants will receive active CO2 laser therapy, while the other half will receive placebo CO2 laser 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
- •Symptoms of vaginal atrophy (dyspareunia and/or vaginal dryness)
- •Menopause
排除标准
- •Systemic or local hormonal therapy the last 6 months
- •Use of moisturizers or lubricants the last month
- •Active genital infection (i.e herpes, vaginitis)
- •Prolapse stage >=2
- •Underlying pathologies that could interfere with the protocol compliance
结局指标
主要结局
10-centimeter Visual Analogue Scale assessing intensity of dyspareunia and dryness
时间窗: 24-months
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
- Density of blood vessels(24 months)
- Day-to Day Impact of vaginal aging questionnaire (DIVA)(24 months)
- King's Health Questionnaire (KHQ)(24 months)
- Patients Global Impression of Improvement(24 months)
- 3 days voiding diary(24 months)
- Number of Blood vessels(24 months)
- Size of blood vessels(24 months)
- Female Sexual Function Index(24 months)
- Vaginal Health Index Score(24 months)
- Cultures of vaginal samples(24 months)
- Polymerase Chain Reaction(24 months)
- 10-centimeter Visual Analogue Scale assessing intensity of itching, burning and dysuria(24 months)
- International Consultation on Incontinence Questionnaire Short Form/Female Lower Urinary tract Symptoms (ICIQ-FLUTS)(24 months)
- Vaginal Maturation Value(24 months)
- Epithelial thickness(24 months)
研究者
Themos Grigoriadis
Assistant Professor
National and Kapodistrian University of Athens