Long-term evaluation of ProACT therapy for stress urinary incontinence in men

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The ProACT Post Approval Study is a five-year, prospective, open-label, multi-center evaluation aimed at assessing the long-term effects of ProACT Adjustable Continence Therapy in men who have undergone prostate surgery. This study will monitor the incidence of urethral stricture and device erosion following ProACT implantation, as well as the impact of this treatment on clinical outcomes after subsequent therapies for stress urinary incontinence. Participants will be required to undergo annual follow-up interviews to track their progress and any complications over the study period.

Why it matters

Who can join: the full rules

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:

    1. Baseline Prostate-Specific Antigen (PSA) of less than or equal to 2.5ng/mL;
    2. 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;
11. 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).
12. Subject has insulin-dependent diabetes that is uncontrolled or not controllable, as indicated by an A1c test result of = 6.5%.

Where it's running

• University of Southern California
  Los Angeles, California, United States Recruiting
• Sutter Health
  Santa Barbara, California, United States Recruiting
• University of Colorado
  Denver, Colorado, United States Recruiting
• University of Florida
  Gainesville, Florida, United States Recruiting
• Urological Research Network Corp
  Hialeah, Florida, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting

Study contacts

• Study coordinator: Matt Kelly, PhD
• Email: usmtk@coloplast.com
• Phone: 6124698882

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.