ProACT Post-Approval Study

Study Overview
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Brief Summary
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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.

Official Title
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Post Approval Study of the ProACT™ Adjustable Continence Therapy for Men

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: ProACT Adjustable Continence Therapy for Men


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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%.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ProACT Adjustable Continence Therapy for Men<br>Patients implanted with ProACT Adjustable Continence Therapy for Men | Device: ProACT Adjustable Continence Therapy for Men<br>* The 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urethral Strictures | Cumulative incidence of ProACT-related clinically relevant urethral strictures over 5 years of follow up. | 5 years | 
| Device Erosions | Cumulative incidence of ProACT device erosions over 5 years of follow-up. | 5 years | 
| Incontinence Quality of Life Questionnaire (I-QoL) | Results on Validated Incontinence Quality of Life Questionnaire | 5 years |