A Post-Market Evaluation of the Altis® Single Incision Sling System Versus Transobturator or Retropubic Mesh Sling in the Treatment of Female Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 416
- 试验地点
- 26
- 主要终点
- Primary Effectiveness Endpoint
研究概览
简要总结
The aim of this postmarket study is to compare the safety and effectiveness of the Altis Single Incision Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36 months.
详细描述
This study is a prospective, post-market, multi-center, cohort assessment comparing Altis SIS (n=178) and transobturator and/or retropubic slings (n=178) in the treatment of stress urinary incontinence at up to 40 U.S. and international sites. Subjects will be followed for a total of 36 months with scheduled visits at 6, 12, 18, 24 and 36 months. The study population will consist of adult female subjects with stress urinary incontinence who are clinically indicated for surgical intervention with a mesh sling.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •The subject is female and at least 18 years of age.
- •The subject is able and willing to complete all procedures and follow-up visits indicated in this protocol.
- •The subject has confirmed stress urinary incontinence (SUI) through cough stress test or urodynamics.
- •The subject has failed two non-invasive incontinence therapies (such as Kegel exercise, behavior modification, pad use, biofeedback, etc.) for > 6 months.
排除标准
- •The subject has an active urogenital infection or active skin infection in region of surgery.
- •The subject has confirmed Pelvic Organ Prolapse (POP) of Stage 2 or higher as determined by POP-Q prolapse grading.
- •The subject is having a concomitant pelvic floor procedure.
- •The subject has incontinence due to neurogenic causes (e.g. multiple sclerosis, spinal cord/brain injury, cerebrovascular accident, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions).
- •The subject had a prior surgical stress urinary incontinence (SUI) treatment.
- •The subject has undergone radiation or brachy therapy to treat pelvic cancer.
- •The subject has urge predominant incontinence by MESA assessment.
- •The subject has an atonic bladder or post void residual (PVR) above 100 cc on ≥ 2 occasions.
- •The subject is pregnant and/or is planning to get pregnant in the future.
- •The subject has a contraindication to the surgical procedure or the product Instructions for Use (IFU).
- •The subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function, without the sponsors approval.
结局指标
主要结局
Primary Effectiveness Endpoint
时间窗: 6 months
Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at least 50% at 6 months.
Primary Safety Endpoint
时间窗: 36 months
Observed device and/or procedure-related serious adverse events through 36 months.
次要结局
未报告次要终点