NCT06231433已完成2 期
Effect of Factional CO2 Laser Treatment on Vaginal Symptoms and Sexual Dysfunction in Women With Systemic Sclerosis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- 1-5 Likert Scale
研究概览
简要总结
Women affected by Systemic Sclerosis and Vulvovaginal Atrophy will be submitted to a cycle composed of five vaginal CO2 laser treatment (SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy - Hi Scan V2LR con sonda vaginale a 360 °, dot power 30 watt, dwell time 1000 μs, dot spacing 1000 μm smart stack 1-3, emission mode deka pulse) every 30-40 days.
At 1-month follow up from the last vaginal laser treatment (6 months from baseline) vagina and sexual health will be assessed by a 1-5 Likert scale, a 0-10 Visual Analogue Scale for vulvovaginal symptoms and the Female Sexual Function Index.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Systemic Sclerosis; - vulvovaginal symptoms
排除标准
- •gynecological neoplasia; - pregnancy; - pelvic organ prolapse; - vaginal and urinary infection; - pudendal neuropathy
研究组 & 干预措施
Women affected by Systemic Sclerosis and vulvovaginal atrophy
Experimental
CO2 vaginal laser
干预措施: CO2 Vaginal Laser (Device)
结局指标
主要结局
1-5 Likert Scale
时间窗: Six months follow up
Scale of satisfaction for the treatment
次要结局
- Female Sexual Function Index(Six months follow up)
- 0-10 Visual Analogue Scale(Six months follow up)
研究者
研究点 (1)
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