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
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 128
- 试验地点
- 1
- 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.
研究组 & 干预措施
AdVance
Active Comparator
sling procedure
干预措施: AdVance® sling procedure (Procedure)
ARGUS
Active Comparator
sling procedure
干预措施: ARGUS Sling procedure (Procedure)
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 (1)
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