ProACT Post-Approval Study

Официальное название

Post Approval Study of the ProACT™ Adjustable Continence Therapy for Men

Обзор

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.

Вмешательства

• Устройство ProACT Adjustable Continence Therapy for Men
  The ProACT therapy consists of two small, adjustable silicone balloons connected with tubing to a port. During a minimally invasive outpatient procedure, the balloons are surgically placed in the area where the prostate was removed or resected.

Первичные конечные точки

• Urethral Strictures [Срок оценки: 5 years]
• Device Erosions [Срок оценки: 5 years]
• Incontinence Quality of Life Questionnaire (I-QoL) [Срок оценки: 5 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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%.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 6 центров

• University of Colorado — Denver
• University of Florida — Gainesville
• Emory University — Atlanta
• University of Kansas Medical Center — Kansas City
• University of Michigan — Ann Arbor
• CentraCare- St. Cloud — Saint Cloud

Идентификаторы

NCT: NCT03767595 · PAS001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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