ProACT Post-Approval Study
- Conditions
- Stress Urinary Incontinence
- Interventions
- Device: ProACT Adjustable Continence Therapy for Men
- Registration Number
- NCT03767595
- Lead Sponsor
- Uromedica
- 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. In addition, the study will evaluate whether treatment with ProACT affects clinical outcomes after subsequent SUI therapies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 145
-
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.
- 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%.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ProACT Adjustable Continence Therapy for Men ProACT Adjustable Continence Therapy for Men Patients implanted with ProACT Adjustable Continence Therapy for Men
- Primary Outcome Measures
Name Time Method Urethral Strictures 5 years Cumulative incidence of ProACT-related clinically relevant urethral strictures over 5 years of follow up.
Device Erosions 5 years Cumulative incidence of ProACT device erosions over 5 years of follow-up.
Incontinence Quality of Life Questionnaire (I-QoL) 5 years Results on Validated Incontinence Quality of Life Questionnaire
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
University of Colorado
🇺🇸Denver, Colorado, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
CentraCare- St. Cloud
🇺🇸Saint Cloud, Minnesota, United States