The Effect of Mid-urethral Sling on the Urethral Dynamic Shape and Motion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Urethral Shape at 3 months
研究概览
简要总结
The purpose of this prospective cohort study is to investigate the effect of sling on urethral dynamic shape and motion using static and dynamic pelvic floor ultrasound and additionally compare the findings among women with successful vs failed surgical outcome.
详细描述
This study is designed as a prospective cohort study. Our hypothesis is that mid-urethral sling provides backstop for excessive "swing motion" of distal urethra and helps with urethral compression along its luminal axis.
Aim 1: Investigate the effect of mid-urethral sling on the urethral shape at rest and maximum Valsalva, in other words dynamic urethral shape.
Aim 2: Compare the effect of mid-urethral sling on urethral dynamic shape in women with successful surgical outcome (absence of stress urinary incontinence at 3 and 12 months after the surgery) and women with surgical failure (presence of stress urinary incontinence at 3 and 12 months after the surgery).
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •stress urinary incontinence interested in treatment with mid-urethral sling
- •able to consent in english and come to post-operative and research visits
排除标准
- •contraindication to mid-urethral sling
- •detrusor overactivity > 40cm H2O
- •post-void residual > 150mL
- •Maximum urethral closure pressure < 40 cm H2O
结局指标
主要结局
Urethral Shape at 3 months
时间窗: 3 months
Urethral shape measured by ultrasound
Urethral Motion at 3 months
时间窗: 3 months
Urethral motion measured by ultrasound
Urethral Shape at 12 months
时间窗: 12 months
Urethral shape measured by ultrasound
Urethral Motion at 12 months
时间窗: 12 months
Urethral motion measured by ultrasound
次要结局
未报告次要终点