Mesh-free Suture Urethropexy for Treating Stress Urinary Incontinence, Efficacy and Durability Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Stress urinary incontinence symptoms
研究概览
简要总结
In this proposed study, the investigators aim to evaluate a modified suture urethropexy technique for the treatment of female stress urinary incontinence.
Participants will be followed with postoperative visits after 2 weeks, 2 months, and 12 months. Pelvic floor ultrasound imaging will be performed before surgery and after 2 months and 12 months, to evaluate urethral mobility.
详细描述
This study is designed as a prospective observational study. The hypothesis is that suture urethropexy will improve stress urinary incontinence symptoms in participants with stress urinary incontinence and normal urethral closure pressure at 2 months and 12 months after surgery.
Specific Aims:
Aim 1: Investigate the efficacy of this mesh-free suture based surgical technique for improving SUI symptoms
Aim 2: Investigate the efficacy of this mesh-free suture based surgical technique on key urethral support defects observed with 3D ultrasound
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
- 是
入选标准
- •18 years or older with stress dominant urinary incontinence
- •Stress urinary incontinence confirmed by testing (e.g. urodynamics)
- •Able to provide informed consent and attend post-operative visits
排除标准
- •Detrusor overactivity (> 40cm H2O)
- •Maximum Urethral Closure Pressure (< 40 cm H2O)
- •Post void residual > 150 mL
- •Prior surgery for stress urinary incontinence with retained material (e.g. bulking agent, sling)
结局指标
主要结局
Stress urinary incontinence symptoms
时间窗: 12 months
Severity of stress urinary incontinence symptoms by questionnaire
Voiding dysfunction
时间窗: Within 1 year of surgery
Rate of urinary retention after surgery
次要结局
- Distal Urethral Motion(12 months)
- Proximal Urethral Motion(12 months)
- Post-operative complications(Within 1 year of surgery)
研究者
Ghazaleh Rostami Nia
Director of Research Division of Urogynecology, NorthShore University HealthSystem
NorthShore University HealthSystem