Multicentric Randomized Clinical Trial Comparing Polyvinylidene Fluoride and Polypropylene Transobturator Suburethral Tapes in the Treatment of Female Stress Urinary Incontinence.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 286
- 试验地点
- 9
- 主要终点
- Effectiveness
研究概览
简要总结
This study evaluates the effectiveness and complications of polyvinylidene fluoride (PVDF) and polypropylene (PP) transobturator suburethral tapes (TOTs) in the treatment of female stress urinary incontinence. Half of participants will be operated with PVDF-TOTs, while the other half will be operated with PP ones.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with stress urinary incontinence.
- •Women with stress-predominant mixed urinary incontinence.
排除标准
- •Incapacity to understand the information or give their consent.
- •Previous anti-incontinence surgery with slings.
- •Low pressure urethra (MUCP < 20cmH2O).
- •Neurogenic bladder.
研究组 & 干预措施
PVDF transobturator tape
Transobturator tension-free suburethral tape made of polyvinylidene fluoride.
干预措施: PVDF transobturator tape (Device)
PP transobturator tape
Transobturator tension-free suburethral tape made of polypropylene.
干预措施: Polypropylene transobturator tape (Device)
结局指标
主要结局
Effectiveness
时间窗: One year
Percentage of patients who are regarded as cured or improved one-year after surgery with both techniques based on the following criteria: * CURED: negative cough stress test and patient must be fully satisfied with the operation (no leaks, no voiding dysfunction, and no use of urinary protection); Patient Global Impresison of Improvement (PGI-I) scale must be "Very much better". * IMPROVED: cough stress test had to be negative and the patient moderately satisfied with the result of surgery due to an increase in urinary frequency and/or sporadic urgency episodes; PGI-I must be "Much better" or "A little better".
次要结局
- Number of participants with adverse events(Up to one year.)