Tension-free Vaginal Tape Management of Stress Incontinence in Women: Randomized Trial of TVT Secur Versus TVT
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 74
- 试验地点
- 8
- 主要终点
- Standardised pad test: "cure" is defined as less than 1g gain in pad weight over the duration of the test
研究概览
简要总结
This randomized multi-centre trial will recruit women with stress urinary incontinence who need surgical treatment for their condition. 300 women will be allocated either to receive a TVT Secur or a standard TVT surgical procedure. The main outcome is effectiveness of the procedure, determined using a 1-hour pad test (which tests for urine leakage) 12 months after surgery. The study will be carried out in 4 to 6 centers and will involve urogynaecologists, urologists and general obstetrician-gynaecologists: all clinicians will have received adequate training.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with stress incontinence, defined as leaking with increased abdominal pressure
- •Eligible for both types of surgery
排除标准
- •Have vaginal prolapse requiring surgical repair
- •Have had previous incontinence surgery
- •Have overactive bladder or incontinence is caused only by bladder overflow
- •Intend to have further children
- •Have Alzheimer's or Parkinson's disease, progressive neurological disease such as multiple sclerosis, or are immunocompromised
- •Are unable to understand English
- •Will be unavailable for follow-up
结局指标
主要结局
Standardised pad test: "cure" is defined as less than 1g gain in pad weight over the duration of the test
时间窗: 12 months following surgery
次要结局
- Satisfaction with surgical outcome(12 months following surgery)
- Cost(up to 12 momths following surgery)
- Utility (15-D)(6 weeks and 12 months following surgery)
- Incontinence-related quality of life (UDI-6, IIQ-7)(6 weeks and 12 months following surgery)
- Return to usual activities(up to 12 months following surgery)
- Surgical complications(up to 12 months following surgery)
- Subjective evidence of cure(12 months following surgery)
- Sexual function (PISQ-12)(12 months following surgery)
- Voiding dysfunction(12 months following surgery)
研究者
Dr. Sue Ross
Adjunct Professor
University of Calgary