NCT01866085Unknown不适用
Randomised Clinical Trial to Evaluate Efficacy of AdVance® vs ARGUS® Sling Procedure in Male With Post Prostatectomy Stress Urinary Incontinence
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Patient satisfaction using the Patient Global Impression of Improvement (PGI-I) score and assess change in 24-hour pad weight .
研究概览
简要总结
The study is designed to assess efficacy and subject satisfaction of two sling devices: Advance and Argus, in male patients with stress urinary incontinence after prostatectomy.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The subject is male
- •The subject is at least 18 years of age
- •The subject has an estimated life expectancy of more than 5 years
- •The subject has confirmed stress urinary incontinence (SUI) through medical history, urodynamics, and/or physical exam for at least 6 months
- •The subject has intrinsic sphincter deficiency due to one of the following:
- •post-TURP, simple open prostatectomy, radical prostatectomy completed at least 6 months prior to implantation date
- •Positive Cough Stress Test (CST):
- •Positive 24-hours Pad Test (PT):
- •A positive PT is confirmed with leakage of >8.O g/24h and < 400 g
- •The subject has completed urodynamics, uroflow, post-void residual, and cystoscopy as per the protocol within 6 months prior to implant
- •The subject is able and willing to complete all follow-up visits and procedures indicated in this protocol
- •The subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the local ethics commit-tee of the respective site
排除标准
- •Subjects who meet any of the following criteria are excluded from entry into the study
- •The subject is unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all follow-up requirements according to the study protocol
- •The subject has an active urogenital infection or active skin infection in region of surgery
- •The subject has serious bleeding disorders
- •The subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury, CVA, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions
- •The subject had a previous implant to treat stress urinary incontinence
- •The subject has undergone radiation, cryosurgery, or brachy therapy to treat prostate or other pelvic cancer within 6 months
- •The subject is likely to undergo radiation therapy within the next 6 months
- •The subject has active urethral or bladder neck stricture disease, requiring continued treatment
- •The subject has urge predominant incontinence
- •The subject has an atonic bladder or a postvoid residual (PVR) ≥150mL
- •The subject has a condition or disorder likely to require future transurethral procedure
- •The subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function without the sponsors'approval
- •Subjects who in the opinion of the investigator are unable and/or unlikely to to comprehend the nature, scope and possible consequences of the study and to follow the study procedures and instructions and complete all study related measurements.
结局指标
主要结局
Patient satisfaction using the Patient Global Impression of Improvement (PGI-I) score and assess change in 24-hour pad weight .
时间窗: 12 months
次要结局
- Assess change in subject satisfaction using questionnaires: ICIQ, UCLA-RAND Incontinence Index.(12 months)
研究者
Jacques Corcos
MD. Professor of Urology, McGill University
Jewish General Hospital
研究点 (2)
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