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

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

This study is testing how well the ProACT therapy works for men with stress urinary incontinence after prostate surgery and checking for any long-term issues with the treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 145 (estimated)
• Ages: 50 Years and up
• Sex: Male
• Sponsor: Uromedica (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 6 sites (Denver, Colorado and 5 other locations)
• Trial ID: NCT03767595 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are men aged 50 and older who have stress urinary incontinence and have previously undergone prostate surgery.

Not a fit: Patients with active urogenital malignancies or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety and efficacy of ProACT therapy, potentially improving treatment options for men suffering from stress urinary incontinence.

How similar studies have performed: While this study builds on existing knowledge of ProACT therapy, it specifically focuses on long-term outcomes, which may provide new insights into its effectiveness and safety.

Eligibility criteria

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 this trial is running

Denver, Colorado and 5 other locations

• University of Colorado — Denver, Colorado, United States (Recruiting)
• University of Florida — Gainesville, Florida, United States (Recruiting)
• Emory University — Atlanta, Georgia, United States (Recruiting)
• University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
• University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
• CentraCare- St. Cloud — Saint Cloud, Minnesota, United States (Recruiting)

Study contacts

• Study coordinator: Patrick Gora

Conditions Stress Urinary Incontinence