ProACT Post-Approval Study
ConditionStress Urinary Incontinence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50+
SponsorUromedica
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ProACT Adjustable Continence Therapy for Men
Treatment groups
145 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov