Surgical Management of Stress Urinary Incontinence in Women: A Randomized Clinical Trial (RCT) of TOT vs TVT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 2
- 主要终点
- Vaginal erosion or other serious adverse outcomes of surgery over 5 years postoperatively
研究概览
简要总结
Stress urinary incontinence (SUI) is a health concern for many women. The transvaginal tape (TVT) surgery has become a common procedure to address the problem. Another surgery is now available, trans-obturator tape (TOT). The investigators will compare these 2 approaches to dealing with SUI and follow the women for 1 year. Women will also be followed at 5 years after surgery.
详细描述
This study is a randomized trial in which women with stress incontinence will be allocated to receive either TOT or TVT procedures. Women who elect surgical management of their type II stress incontinence are eligible to participate in the trial. Baseline data, including a patient questionnaire, will be collected. Hospital outcomes, including length of stay and surgical complications will be documented from hospital charts. All women attend a 6-week follow-up visit as standard of care: a structured data collection form will be used by surgeons to collect information and another patient questionnaire will be administered. At 12 months postoperatively women will attend the clinic for objective measurement of incontinence, a full exam and to complete a questionnaire. The main outcome is effectiveness of the procedure determined using a 1-hour pad test. Secondary research questions include:
How effective is TOT compared to TVT in terms of:
Subjective cure at 12 months postoperatively? Incontinence-specific quality of life at 6 weeks and 12 months postoperatively? Satisfaction with surgery at 12 months postoperatively? Return to usual activities and usual sex life after surgery? The prevalence of voiding dysfunction at 12 months postoperatively? Surgical complications, both short term and long term? Utility and cost? (an economic evaluation) The study will be carried out according to the ICH Good Clinical Practice Guidelines.
At 5 years postoperatively women will attend the clinic for a further follow-up. The primary research question of the 5-year follow-up is:
Safety - What is the incidence of vaginal erosion or other serious adverse outcomes of surgery among women who had a surgical procedure for stress urinary incontinence utilizing a TOT device, versus a TVT device, over the 5 years following surgery?
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with type II stress incontinence, defined as leaking with increased abdominal pressure
- •Are 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
Vaginal erosion or other serious adverse outcomes of surgery over 5 years postoperatively
时间窗: 5 years
How effective is TOT compared to TVT in terms of objective cure at 12 months postoperatively?
时间窗: 1 year
Objective evidence of SUI will be obtained using a standardised pad test undertaken at 12 months following surgery. The pad test will be carried out using a modification of the International Continence Society (ICS) recommendations. Women will be considered 'cured' if the pad weight gain is less than 1g over the test period. This is the definition of cure used by Ward and will allow comparison with that trial.
次要结局
- Utility and cost? (an economic evaluation)(1 year)
- How effective is TOT compared to TVT in terms of subjective cure 12 months postoperatively?(1 year)
- Incontinence-specific quality of life at 6 weeks and 12 months postoperatively?(1 year)
- Return to usual activities and usual sex life after surgery?(6 weeks and 1 year)
- Subjective effectiveness at 5 years postoperatively(5 years)
- Objective effectiveness at 5 years postoperatively(5 years)
- Satisfaction with surgery at 12 months postoperatively?(1 year)
- The prevalence of voiding dysfunction at 12 months postoperatively?(1 year)
- Surgical complications, both short term and long term?(6 weeks and 1 year)
- Health care utilization over 5 years postoperatively(5 year)
- Incontinence-specific quality of life at 5 years postoperatively(5 years)
- Cost effectiveness over 5 years postoperatively(5 year)
研究者
Dr. Sue Ross
Adjunct Professor, Obstetrics and Gynecology
University of Calgary