Status:
RECRUITING
ProACT Post-Approval Study
Lead Sponsor:
Uromedica
Conditions:
Stress Urinary Incontinence
Eligibility:
MALE
50+ years
Phase:
NA
Brief Summary
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. ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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%.
Key Trial Info
Start Date :
February 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT03767595
Start Date
February 19 2019
End Date
September 1 2030
Last Update
November 29 2024
Active Locations (6)
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1
University of Colorado
Denver, Colorado, United States, 80045
2
University of Florida
Gainesville, Florida, United States, 32610
3
Emory University
Atlanta, Georgia, United States, 30322
4
University of Kansas Medical Center
Kansas City, Kansas, United States, 66103