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(352) 733-0111

ProACT Post-Approval Study

  • Status
    Accepting Candidates
  • Age
    50 Years - N/A
  • Sexes
    Male
  • Healthy Volunteers
    Accepts Healthy Volunteers
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Objective

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.

Details

Full study title Post Approval Study Plan of the ProACT Adjustable Continence Therapy for Men
Protocol number OCR32422
ClinicalTrials.gov ID NCT03767595
Phase N/A

Eligibility

Inclusion Criteria:

  1. Subject is a male of at least 50 years of age.

  2. Subject demonstrates stress urinary incontinence.

  3. Subject has undergone a radical prostatectomy, transurethral resection of the prostate, or other prostate surgery.

  4. Subject is willing and able to undergo surgical implantation of ProACT devices.

  5. 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.

  6. Subject is willing and able to sign the approved informed consent.

  7. 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).

  8. Subject has a negative urine culture.

  9. Subject has no known urogenital malignancy, other than previously treated prostate cancer.

  10. Subject meets ONE of the following criteria:

  11. Baseline Prostate-Specific Antigen (PSA) of less than or equal to 2. 5ng/mL;

  12. 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;

  13. Physician determines subject to be a suitable surgical candidate.

Exclusion Criteria:

  1. Subject has an existing urethral stricture, a history of any urethral strictures, or has ever had a urethrotomy.

  2. Subject has undergone prostate surgery or any anti-incontinence surgery within the last 12 months.

  3. Subject has an artificial urinary sphincter or any components of a previously implanted artificial urinary sphincter in vivo.

  4. Subject has undergone radiation therapy in the prostatic area within the last 12 months.

  5. Subject has untreated or unsuccessfully treated detrusor instability or over-activity.

  6. Subject has an atonic bladder.

  7. Subject had, presently has, or is suspected of having bladder cancer.

  8. Subject has untreated or unsuccessfully treated bladder stones.

  9. Subject has detrusor sphincter dyssynergia.

  10. Subject has known hemophilia or a bleeding disorder.

  11. Subject has a known severe contrast solution allergy (e.g., anaphylaxis, cardiac, or

respiratory arrest).

  1. Subject has insulin-dependent diabetes that is uncontrolled or not controllable, as

indicated by an A1c test result of = 6.5%.

Lead researcher

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.