NCT03767595招募中不适用
Post Approval Study of the ProACT™ Adjustable Continence Therapy for Men
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Uromedica
- 入组人数
- 145
- 试验地点
- 12
- 主要终点
- Urethral Strictures
研究概览
简要总结
The ProACT Post Approval Study is a 5-year prospective, open-label, multi-center study designed to evaluate the long-term incidence of urethral stricture and device erosion after ProACT implantation. In addition, the study will evaluate whether treatment with ProACT affects clinical outcomes after subsequent SUI therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject is a male of at least 50 years of age.
- •Subject demonstrates stress urinary incontinence.
- •Subject has undergone a radical prostatectomy, transurethral resection of the prostate, or other prostate surgery.
- •Subject is willing and able to undergo surgical implantation of ProACT devices.
- •Subject is willing and able to comply with study-required
- •follow-up activities, including annual telephonic follow -up interviews, for a period of 5 years from their date of initial implantation. This includes compliance even after possible explant of ProACT devices and/or possible implantation of subsequent therapies.
- •Subject is willing and able to sign the approved informed consent.
- •Subject has two positive 24-hour pad weight tests (greater than or equal to 8 gram pad weight increase demonstrated in two 24-hour pad weight tests).
- •Subject has a negative urine culture.
- •Subject has no known urogenital malignancy, other than previously treated prostate cancer.
- •Subject meets ONE of the following criteria:
- •Baseline Prostate-Specific Antigen (PSA) of less than or equal to 2.5ng/mL;
- •Baseline PSA > 2.5ng/mL and less than or equal to 10 ng/mL AND free PSA greater than or equal to 25% of total PSA;
- •Physician determines subject to be a suitable surgical candidate.
排除标准
- •Subject has an existing urethral stricture, a history of any urethral strictures, or has ever had a urethrotomy.
- •Subject has undergone prostate surgery or any anti-incontinence surgery within the last 12 months.
- •Subject has an artificial urinary sphincter or any components of a previously implanted artificial urinary sphincter in vivo.
- •Subject has undergone radiation therapy in the prostatic area within the last 12 months.
- •Subject has untreated or unsuccessfully treated detrusor instability or over-activity.
- •Subject has an atonic bladder.
- •Subject had, presently has, or is suspected of having bladder cancer.
- •Subject has untreated or unsuccessfully treated bladder stones.
- •Subject has detrusor sphincter dyssynergia.
- •Subject has known hemophilia or a bleeding disorder.
- •Subject has a known severe contrast solution allergy (e.g., anaphylaxis, cardiac, or respiratory arrest).
- •Subject has insulin-dependent diabetes that is uncontrolled or not controllable, as indicated by an A1c test result of = 6.5%.
结局指标
主要结局
Urethral Strictures
时间窗: 5 years
Cumulative incidence of ProACT-related clinically relevant urethral strictures over 5 years of follow up.
Device Erosions
时间窗: 5 years
Cumulative incidence of ProACT device erosions over 5 years of follow-up.
Incontinence Quality of Life Questionnaire (I-QoL)
时间窗: 5 years
Results on Validated Incontinence Quality of Life Questionnaire
次要结局
未报告次要终点
研究者
研究点 (12)
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