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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-ProAct Post-Approval Study


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General
Study Status Progress Adequate
Application Number P130018 / PAS001
Date Current Protocol Accepted  
Study Name OSB Lead-ProAct Post-Approval Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The ProACT PAS 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.
Study Population Description Inclusion Criteria

1. Subject is a male of at least 50 years of age.

2. Subject demonstrates stress urinary incontinence.

3. Subject has undergone a radical prostatectomy, transurethral resection of the prostate, or other prostate surgery.

4. Subject is willing and able to undergo surgical implantation of ProACT devices.

5. 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.

6. Subject is willing and able to sign the approved informed consent.

7. 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).

8. Subject has a negative urine culture.

9. Subject has no known urogenital malignancy, other than previously treated prostate cancer.

10. Subject meets ONE of the following criteria:

a. Baseline PSA less than or equal to 2.5ng/mL;

b. 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;

11. Physician determines subject to be a suitable surgical candidate.

Exclusion Criteria

1. Subject has an existing urethral stricture, a history of any urethral strictures, or has ever had a urethrotomy.

2. Subject has undergone prostate surgery or any anti-incontinence surgery within the last 12 months.

3. Subject has an artificial urinary sphincter or any components of a previously implanted artificial urinary sphincter in vivo.

4. Subject has undergone radiation therapy in the prostatic area within the last 12 months.

5. Subject has untreated or unsuccessfully treated detrusor instability or over-activity.

6. Subject has an atonic bladder.

7. Subject had, presently has, or is suspected of having bladder cancer.

8. Subject has untreated or unsuccessfully treated bladder stones.

9. Subject has detrusor sphincter dyssynergia.

10. Subject has known hemophilia or a bleeding disorder.

11. Subject has a known severe contrast solution allergy (e.g., anaphylaxis, cardiac, or respiratory arrest).

12. Subject has insulin-dependent diabetes that is uncontrolled or not controllable, as indicated by an A1c test result of = 6.5%.

Sample Size 145 subjects will be enrolled at 5 to 7 clinical sites in the U.S.
Data Collection 1. Cumulative incidence of ProACT-related clinically relevant urethral strictures over 5 years of follow up.

2. Cumulative incidence of ProACT device erosions over 5 years of follow-up.

3. Incontinence Quality of Life Questionnaire (I-QoL) over 5 year of follow-up.

4. Choice of subsequent SUI therapy(ies) post ProACT treatment.

Follow-up Visits and Length of Follow-up 5 years


OSB Lead-ProAct Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 05/24/2016 05/23/2016 On Time
one year report 11/23/2016 11/23/2016 On Time
18 month report 05/24/2017 05/22/2017 On Time
two year report 11/23/2017    
three year report 11/23/2018    
four year report 11/23/2019    
five year report 11/22/2020    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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