NCT03301818已完成不适用
Vaginal Elasticity Assessment Before and After the Affect of Surgical Repair for Urinary Stress Incontinence (USI) on Vaginal Elasticity 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
- 23
- 试验地点
- 1
- 主要终点
- Vaginal elasticity assessment
研究概览
简要总结
Female patients with USI will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after surgery for the repair of the USI. Surgical repair will be performed by a single surgeon who will perform a tension free vaginal tape obturator (TVT-O) repair.
详细描述
Patients will be recruited and sign a consent form. The patients included are patients with USI that are candidates for a TVT-O 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
- Na
- 干预模型
- Single Group
- 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 USI repair.
排除标准
- •Women with high grade pelvic floor prolapse.
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
Principal Investigator
Rambam Health Care Campus
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Vaginal Tactile Imaging for the Assessment of Pelvic Organ Prolapse Repair EfficiencyPelvic Organ ProlapseNCT03311685Rambam Health Care Campus30
已完成
不适用
Vaginal Elasticity Assessment Before and After Vaginal Carbon Dioxide Laser Treatment.Laser BurnNCT03630406Rambam Health Care Campus25
已完成
不适用
Vaginal Elasticity Assessment Before and After Brachytherapy/Pelvic RadiationRadiation InjuriesNCT03667859Rambam Health Care Campus25
终止
不适用
Physiologic Elasticity Changes During Pregnancy and After Labor.Vaginal ProlapseNCT03930290Rambam Health Care Campus12
已完成
不适用
Development Study Using Vaginal Tactile ImagerPelvic Organ ProlapseNCT01111916Artann Laboratories31