Mid-Urethral Sling Tensioning Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 318
- 试验地点
- 2
- 主要终点
- Abnormal Bladder Function
研究概览
简要总结
Prospective randomized clinical trial comparing two methods of intra-operative tensioning of retropubic midurethral slings for stress urinary incontinence. Primary outcome is rate of abnormal bladder function. Secondary outcomes include validated quality of life scores, physical exam findings, and rates of immediate post operative voiding dysfunction.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 or older
- •Women who have elected for surgical management of symptomatic urinary incontinence
- •Ability to read & write in English
- •Other prolapse surgery at time of sling placement is allowed
- •Must consent to participation in trial
排除标准
- •Women with a prior incontinence procedure
- •Clinically obvious, but non-symptomatic stress urinary incontinence (latent stress incontinence)
- •Declines participation in trial
- •Women with existing urinary retention or significant overactive bladder (requiring medication)
结局指标
主要结局
Abnormal Bladder Function
时间窗: 1 year post operative
Abnormal post-operative bladder function a composite outcome assessed at 12 months after surgery. It is one or more of the following: 1) significantly bothersome stress incontinence or over active bladder symptoms after surgery as measured by questions 1, 2, 3 of the Urogential Distress Inventory (UDI-6) 2) a positive cough stress test in the office, 3) re-treatment for stress urinary incontinence (repeat surgery or pessary use), 4) post-operative urinary retention (presence of self-catheterization at 6 weeks post-operatively or beyond, or therapeutic intervention for retention at any time during the 12 months after, such as pelvic floor physiotherapy, sling lysis, urethrolysis, or sacral nerve stimulation.
次要结局
- Duration of catheterization after surgery(12 months)
- Rate of discharge from hospital with on-going need for catheterization(12 months)
- Questionnaire scores(12 months)
- Pad test(12 month)
- Uroflow parameters(12 months)
研究者
Erin Brennand
Dr.
University of Calgary