Vaginal Elasticity Assessment Before and After the Affect of Surgical Repair for Pelvic Organ Prolapse (POP) on Vaginal Elasticity as Measured by Vaginal Tactile Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Vaginal elasticity assessment
研究概览
简要总结
Female patients with POP will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after surgery for the repair of the POP. Surgical repair will be performed by a single surgeon who will perform either a laparoscopic or vaginal repair.
详细描述
Patients will be recruited and sign a consent form. The patients included are patients with POP that are candidates for either laparoscopic or vaginal repair.
Assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different points:
- The day of surgery before surgery.
- The day after surgery.
- 3 months post-operational. 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
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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 POP repair
排除标准
- •Women above or below the age limit
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 measuring the local vaginal pressure (in mmHg)
次要结局
- Comparison of vaginal elasticity between repair methods(Up to 3 months from enrollment)
研究者
ROY LAUTERBACH MD
Principal Investigator
Rambam Health Care Campus