NCT01170728终止不适用
Virtue® Male Sling Fixation Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 10
- 主要终点
- Improvement of incontinence
研究概览
简要总结
This study is a multi-center study that will assess the efficacy and safety of suture fixation of the Virtue® Male 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
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subject at least 18 years of age with an estimated life expectancy of 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 completed post-void residual per protocol within 6 weeks prior to implant
- •The subject has completed cystoscopy as per protocol within 12 months prior to implant
- •The subject has intrinsic sphincter deficiency due to one of the following: post-transurethral resection of the prostate (TURP), simple open prostatectomy, or radical prostatectomy completed at least 6 months prior to implantation date
- •The subject has failed at least two non-invasive therapies, eg. pelvic/Kegel exercises, behavioral modification or biofeedback for at least 6 months
- •The subject is willing to have the Virtue® Male Sling implanted
- •The subject is able and willing to complete all follow-up visits and procedures indicated in the 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 committee of the respective site
排除标准
- •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 urinary tract 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, cerebrovascular accident (CVA), detrusor-external sphincter dyssynergia, Parkinson's disease, or similar condition
- •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) greater than or equal to 150 milliliters (mL)
- •The subject has a condition or disorder likely to require future transurethral procedure
- •The subject is enrolled in a concurrent clinical study of any treatment (drug or device) that could affect continence function without sponsor's approval
- •The subject is deemed unfit for male sling implantation or participation in a research protocol as determined by attending physician
结局指标
主要结局
Improvement of incontinence
时间窗: 3 months post implant
Safety of the device characterized by reported adverse events
时间窗: 3 months
次要结局
- To characterize incontinence severity at various time points(24 months)
- To evaluate patient quality of life at specified time points(24 months)
研究者
研究点 (10)
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