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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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AE and effectiveness rates


 
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General
Study Status Progress Adequate
522 Number / Requirement Number PS130039 / PSS001
Date Current Plan Accepted 02/11/2019
Study Name AE and effectiveness rates
Root Document Number K121562 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is a prospective, multi-center, cohort assessment comparing Altis SIS and transobturator and/or retropubic slings in the treatment of stress urinary incontinence, at up to 40 U.S. and International sites.

Study Population Description The study population will consist of adult female subjects with stress urinary incontinence who are clinically indicated for surgical intervention with a mesh sling, who have received Altis SIS as part of the previous IDE study (CP006SU [G100229]) or who are currently clinically indicated for surgical intervention with a mesh sling. All study candidates who provide written informed consent and meet all of the inclusion criteria and none of the exclusion criteria will be included in the study.

Sample Size Sample size was calculated to assess non-inferiority of the primary efficacy endpoint and primary safety endpoint at 80% power with a type-1 error rate of 0.05 for each primary endpoint analysis. The final sample size was determined to be the maximum of these sample size calculations for the primary efficacy and safety endpoints. This requires 328 total subjects from up to 40 sites, comparing Altis SIS (n=178) and transobturator and/or retropubic slings (n=178) in the treatment of stress urinary incontinence

Data Collection Primary Safety Endpoints Observed device and/or procedure-related serious adverse events through 36-months. Primary Effectiveness Endpoint Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at least 50 % at 6 months. Secondary Safety Endpoints Observed rates of device and/or procedure-related adverse events defined as organ perforation, bleeding, mesh exposure in the vagina, mesh erosion into the bladder, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary problems and neuromuscular problems at 6 months, 12 months, 18 months, 24 months, and 36 months post index procedure. Observed adverse events within 6 months, 12 months, 18 months, 24 months, and 36 months of the index procedure. Observed revision/re-surgery at the index level at 6 months, 12 months, 18 months, 24 months, and 36 months. Secondary Effectiveness Endpoint Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at least 50 % at 12 months, 18 months, 24 months, and 36 months. Quality of Life at 6 months, 12 months, 18 months, 24 months, and 36 months as measured through: Patient Global Impression of Improvement (PGI-1) Urogenital Distress Inventory (UDI-6) Incontinence Impact Questionnaire-Short Form (IIQ-7)

Follow-up Visits and Length of Follow-up The length of follow-up is 3 years. Data will be collected following the index procedure at 6 months, 12 months, 18 months, 24months, and 36 months.



AE and effectiveness rates Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 06/06/2014 06/06/2014 On Time
12 month report 03/24/2015 03/18/2015 On Time
18 month report 09/23/2015 09/24/2015 Overdue/Received
2 year report 04/06/2016 04/06/2016 On Time
3 yr report 03/22/2017 03/20/2017 On Time
4 yr report 03/22/2018 03/23/2018 On Time
5 yr report 03/22/2019 03/25/2019 Overdue/Received
6 year report 03/22/2020 03/24/2020 Overdue/Received
final Report 11/30/2021    


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