Actively Recruiting
ProACT Post-Approval Study
Led by Uromedica · Updated on 2024-11-29
145
Participants Needed
6
Research Sites
601 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ProACT Post-Approval Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 50 years or older
- Has stress urinary incontinence
- Has undergone radical prostatectomy, transurethral resection of the prostate, or other prostate surgery
- Willing and able to have ProACT device surgically implanted
- Willing and able to comply with all study follow-up activities, including annual phone interviews, for 5 years
- Willing and able to sign informed consent
- Has two positive 24-hour pad weight tests showing at least 8 grams increase
- Has a negative urine culture
- Has no known urogenital cancer other than treated prostate cancer
- Meets one of the following PSA criteria:
- Baseline PSA less than or equal to 2.5 ng/mL; or
- Baseline PSA greater than 2.5 ng/mL and less than or equal to 10 ng/mL with free PSA at least 25% of total PSA
- Determined by physician to be suitable for surgery
You will not qualify if you...
- Has existing or history of urethral strictures or has had urethrotomy
- Had prostate or anti-incontinence surgery in the last 12 months
- Has an artificial urinary sphincter implanted
- Received radiation therapy to the prostate area in the last 12 months
- Has untreated or unsuccessfully treated bladder muscle instability or overactivity
- Has an atonic bladder
- Has or is suspected to have bladder cancer
- Has untreated or unsuccessfully treated bladder stones
- Has detrusor sphincter dyssynergia
- Has known bleeding disorder such as hemophilia
- Has severe allergy to contrast solution
- Has uncontrolled insulin-dependent diabetes with A1c greater than 6.5%
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
University of Colorado
Denver, Colorado, United States, 80045
Actively Recruiting
2
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
3
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
University of Kansas Medical Center
Kansas City, Kansas, United States, 66103
Actively Recruiting
5
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
6
CentraCare- St. Cloud
Saint Cloud, Minnesota, United States, 56303
Actively Recruiting
Research Team
P
Patrick Gora
CONTACT
T
Timothy C Cook, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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