Randomized Controlled Study Comparing Two Types of Suburethral Slings for the Surgical Treatment of Female Stress Incontinence : TVT and TVT-O.
试验速览
- 阶段
- 4 期
- 入组人数
- 180
- 试验地点
- 27
- 主要终点
- pre operative complication: rate of bladder perforation
研究概览
简要总结
The purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence: TVT and TVT-O.
详细描述
Urinary stress incontinence (USI) is a frequent pathology in women. Surgical treatment is required in 30 to 50% of women presenting with USI. Several surgical techniques are currently available.
At the present time, the placement of suburethral slings is one of the most efficient techniques. Furthermore, the placement of a suburethral sling is known to be associated with a low rate of complications.
Currently, two approaches are available for the placement of a suburethral sling: retropubic approach (TVT) and trans-obturator approach (TVT-O). The efficacy of these two approaches seem equivalents. However, the morbidity related to these two techniques is probably different. In retrospective studies, the retropubic approach is associated with a higher rate of bladder perforation. On the other hand, the trans-obturator approach is supposed to be associated with a higher rate of post-operative pain.
Thus, the purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence: TVT and TVT-O.
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 95 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman over 18 years old
- •Clinical diagnosis of stress urinary incontinence requiring surgical management
- •Must be able to read and sign the consent
排除标准
- •Pregnancy
- •Anti-coagulant treatment
- •Isolated overactive bladder syndrome
- •Genital prolapse requiring surgical treatment
- •Concomitant hysterectomy
结局指标
主要结局
pre operative complication: rate of bladder perforation
post operative complication: rate of post-operative pain
次要结局
- efficacy: disparation of urinary incontinence
- safety: sexual behaviour