NCT03630406已完成不适用
Vaginal Elasticity Assessment Before and After Vaginal Carbon Dioxide Laser Treatment.as Measured by Vaginal Tactile Imaging.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Vaginal elasticity assessment
研究概览
简要总结
Female patients with either stress urinary incontinence (SUI) or vaginal wall weakness and prolapse will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after Carbon Dioxide laser treatment.
详细描述
Patients will be recruited and sign a consent form. The patients included are patients with SUI or vaginal wall weakness and prolapse. Each participant undergoes 3 laser treatments 4 weeks apart.
Assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different points:
- Before the first treatment session (baseline).
- Before and after each treatment session.
- 3 months post final treatment. Every patient will serve as her own control. Demographic, gynecologic and obstetric history will be obtained from patients' electronic files.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Any woman undergoing vaginal Carbon Dioxide laser treatment.
排除标准
- •Women that are not in the age range.
结局指标
主要结局
Vaginal elasticity assessment
时间窗: up to 3 months from enrollment
Vaginal elasticity as measured by the vaginal tactile imager
次要结局
未报告次要终点
研究者
ROY LAUTERBACH MD
Primary Investigator
Rambam Health Care Campus
研究点 (1)
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