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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
ProACT Adjustable Continence Therapy for Men
DeviceThe ProACT therapy consists of two small, adjustable silicone balloons connected with tubing to a port. During a minimally invasive outpatient procedure, the balloons are surgically placed in the area where the prostate was removed or resected.
Treatment groups
145 Participants
are divided into 1 treatment groupGroup A: ProACT Adjustable Continence Therapy for MenExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Urethral Strictures
Cumulative incidence of ProACT-related clinically relevant urethral strictures over 5 years of follow up.
Time frame
5 years2
Device Erosions
Cumulative incidence of ProACT device erosions over 5 years of follow-up.
Time frame
5 years3
Incontinence Quality of Life Questionnaire (I-QoL)
Results on Validated Incontinence Quality of Life Questionnaire
Time frame
5 yearsOther outcomes
1
Effect of ProACT on Subsequent Stress Urinary Incontinence(SUI) Therapy
This data will be collected with a "Post ProACT Explant Subsequent Therapy Questionnaire". This questionnaire will ask 3 questions regarding the ProACT therapy 1. Did the ProACT therapy have a detrimental effect on the difficulty of the subsequent implant surgery? 2. Did the ProACT therapy significantly increase the time required to implant the subsequent implant surgery? 3. Did the ProACT therapy increase the surgical complication rate during the subsequent implant surgery? The scale for each question is 0-1. 0 Meaning no effect (a "No" response on the questionnaire) and 1 being some effect ("Yes" response on the questionnaire). No effect (0) on subsequent SUI therapies is the better outcome.
Time frame
5 years Source ClinicalTrials.gov