Retropubic vs. Transobturator Tension-free Vaginal Tape (TVT vs. TVT-O): A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 564
- 试验地点
- 8
- 主要终点
- Continence
研究概览
简要总结
The so-called tension-free vaginal tape (TVT), first described in Sweden in 1996, has become a standard operation worldwide for the treatment of women with stress urinary incontinence. This tape is placed from the vagina behind the pubic bone and exits through the skin of the lower abdomen, just above the pubic bone. In 2001 a urologist in France proposed passing a similar tape laterally (as opposed to behind the pubic bone). This tape is passed through a window of the pelvic bones (the so-called obturator foramen), by what is called a transobturator approach. It is passed through the skin of the thigh (as opposed to the lower abdomen). The reason for this modification was to avoid injuring the bladder and, possibly, provide a more physiologic restoration of the continence mechanism. However, it is unclear whether the lateral (so-called transobturator approach) is as good as or better than the initial approach behind the pubic bone.
The purpose of the present study is to compare the standard (retropubic) and the newer (transobturator) approach for the placement of a tape for treating women with stress urinary incontinence.
详细描述
After informed consent women scheduled for surgery for stress urinary incontinence are randomized to receive a tension-free vaginal tape either by the retropubic or the transobturator approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Planned surgery for primary stress incontinence (positive stress test at bladder filling of 300 ml) without concomitant prolapse surgery or hysterectomy
- •Patient able and willing to participate in follow-up
- •Informed consent
排除标准
- •Detrusor overactivity, predominant complaint overactive bladder (OAB)
- •Major concomitant surgery
- •Prolapse beyond introitus or any prolapse necessitating surgery
- •Previous incontinence surgery other than colporrhaphy
- •Residual urine >100 ml
- •Neurologic disease
- •Allergy to local anesthetic agents
- •Coagulation disorders
结局指标
主要结局
Continence
时间窗: 5 years
次要结局
- Quality of life(5 years)
研究者
Karl Tamussino, MD
PI
Austrian Urogynecology Working Group (AUWG)
