Synthetic Versus Autologous Sling For Stress Incontinence (SASSI): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- Objective urinary incontinence status measured by standing cough test
研究概览
简要总结
This is a multi-centre randomized controlled trial comparing mid-urethral synthetic mesh sling or tension-free vaginal tape (TVT) and autologous fascia sling (AFS) in elderly patients with stress predominant urinary incontinence. The investigators aim to investigate new onset pelvic pain 6 months post-op and objective urinary incontinence cure rate 5 years post-op. Secondary objectives include investigation of opioid use, mental health, sexual health, and other post-op outcomes.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult females at birth (female anatomy, any gender)
- •Greater than or equal to 60 years old
- •Have stress predominant urinary incontinence (spUI) eligible for both types of surgery (tension-free vaginal tape and autologous fascia sling)
- •Exhausted conservative management options for UI (Kegel's exercises, physiotherapy, pessary)
- •Completed childbearing
- •Able to follow up with clinic visits for up to five years after surgery
排除标准
- •Clinical Frailty Score of 6 or more, as moderate frailty is likely associated with excessive postoperative deterioration
- •Concurrent pelvic surgery
- •Neurogenic bladder
- •Previous UI surgery
- •Previous pelvic radiation
- •Previous mesh exposure
- •Presence of pelvic pain for more than three months in the last five years
- •Likely unable to follow up
- •Immunocompromised individuals receiving immunosuppressive medications for at least 3 months
- •Chronic systemic steroid use for at least 3 months for autoimmune diseases
- •Unable to stop smoking for at least 3 months prior to surgery and at high risk of restart smoking post-operatively
研究组 & 干预措施
tension-free vaginal tape
干预措施: tension-free vaginal tape (Procedure)
autologous fascia sling
干预措施: autologous fascia sling (Procedure)
结局指标
主要结局
Objective urinary incontinence status measured by standing cough test
时间窗: 5 years post-op
Unit of measure: proportion of participants Measurement tool: standing cough test positive, yes/no
Incidence of new-onset chronic abdominopelvic pain since surgery by Likert pain intensity scale
时间窗: 6 months post-op
Proportion of participants who report new abdominopelvic pain with an average intensity greater than 3 on a 0-10 Likert pain intensity scale over the past 6 months
次要结局
未报告次要终点
研究者
Roxana Geoffrion
Associate Professor
University of British Columbia