Sonographic Evaluation of the Single-incision Needleless (Contasure-needleless®) Mini-sling Placement to Predict Success
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- The correlation of failure with the sonographic features of the mesh
研究概览
简要总结
Transperineal ultrasonography is gaining importance in preoperative and postoperative evaluation of the patient with urinary incontinence with allowing well detailed information about the anterior compartment.
There is little evidence that transperineal sonography can aid surgeons to predict the success or failure after mid-urethral slings.
We aimed to investigate the efficacy of sonography in mini-sling operations to predict the success or failure.
详细描述
Women who are scheduled for anti-incontinence operation due to their stress urinary incontinence will be pre- and postoperatively evaluated by transperineal and introital ultrasound.
Patients will be followed for at least 1 year.
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
- •Patients with clinically stress urinary incontinence
- •Patients who claim that their condition severely impair their quality of life
- •Patients who are failed on conservative management (life style changes and pelvic floor exercises)
排除标准
- •Patients who have unregulated diabetes mellitus (they will be included after appropriate and sustainable blood glucose regulation)
- •Patients who have neurological condition that may affect the incontinence
- •Patients who have psychiatric disease that may affect the subjective evaluation.
结局指标
主要结局
The correlation of failure with the sonographic features of the mesh
时间窗: Evaluation at postoperative 1st and 4th weeks
Patients will be accepted as failure if their stress test is positive Sonographic features of the mesh includes the shape of the mesh, the distance to the mid-urethra, the position related to the proximal urethra and the angle between the mesh arms on coronal axis
次要结局
- POP-Q(Evaluation at postoperative 1st and 4th weeks and preoperatively)
- Nocturia(Evaluation at postoperative 1st and 4th weeks and preoperatively)
- Subjective success(Evaluation at postoperative 1st and 4th weeks)
- Anterior compartment mobility angles(Evaluation at postoperative 1st and 4th weeks and preoperatively)
- Urge symptoms(Evaluation at postoperative 1st and 4th weeks and preoperatively)
- Anterior compartment mobility distances(Evaluation at postoperative 1st and 4th weeks and preoperatively)
研究者
Murat Yassa
Principal Investigator
Bartin State Hospital