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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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POP AE and Effectiveness rates, registry

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Study Status Progress Adequate
522 Number / Requirement Number PS120106 / PSS001
Date Current Plan Accepted 05/25/2018
Study Name POP AE and Effectiveness rates, registry
Root Document Number K092207 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
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 is a prospective, multi-center, cohort study comparing Restorelle mesh to native tissue repair in the treatment of pelvic organ prolapse.
Study Population Description The study population will consist of adult female subjects with with pelvic organ prolapse that are clinically indicated for surgical intervention for pelvic floor reconstruction.

Native tissue repair subjects will be drawn from a pool of shared controls, of which Coloplast will contribute a specified number of subjects. The exact number of subjects will be determined by the number of control subjects required for each company participating in the AUGS registry and the expected proportion of subject in each treatment combination.

In order to maintain study power and minimize subject loss in the control group, Coloplast defines eligible control subjects as follows:

• All native tissue repair subjects enrolled into the Coloplast Restorelle study

• Control subjects enrolled into another sponsor’s studies who met the Restorelle 522 inclusion and exclusion criteria

• In the event there are more than 223 subjects available in the control arm for either cohort (the Coloplast Restorelle study or other sponsor’s studies): All eligible control subjects enrolled in the Coloplast Restorelle study will be utilized

• SAS will be utilized to select a random sample of eligible subjects from the non-Coloplast Restorelle study to increase the control group size to 223.

Sample Size 892 subjects (223 patients treated with Restorelle Direct Fix A Transvaginal Mesh, 223 patients treated with Restorelle Direct Fix P Transvaginal Mesh and 446 patients treated with Native Tissue Repair) will be enrolled at up to 60 study centers
Data Collection "Primary Effectiveness Endpoint: Recurrent prolapse at 12 months; Primary Safety Endpoint: The primary safety endpoint is defined as device and/or procedure-related serious adverse events (SAEs) at 12-months as determined by the Clinical Events Committee. Secondary Safety Endpoints:

Each of the following set of device or procedure related AEs at 36 months (mesh erosion into another organ, neuromuscular problems (including groin and leg pain), pelvic pain, mesh exposure in the vagina, infection (by type), stress urinary incontinence, urge incontinence, difficulty emptying bladder, de novo dyspareunia); Additional Endpoints: 1. All other AEs; 2. Primary and secondary safety endpoints stratified by compartment; 3. Primary and secondary safety endpoints listed by severity; 4. Primary and secondary effectiveness outcomes stratified by compartment; 5. Primary and secondary safety endpoints stratified by subjects requiring and not requiring re-surgery after the initial transvaginal pelvic organ prolapse surgery overall, and stratified by compartment; 6. Quality of life score differences from baseline overall, and stratified by compartment; 7. Quality of life score improvement from baseline for subjects requiring re-surgery following the index procedure overall, and stratified by compartment; 8. Quality of life score improvement from baseline for subjects with similar conditions with and without surgical intervention (e.g. pessary); 9. Prolapse at or beyond the hymenal ring just prior to mesh removal surgery among those who have and have not had all or part of their mesh removed post-operatively; 10. Bulge for each vaginal compartment in which mesh is placed; 11. Revision and/or re-surgery."

Follow-up Visits and Length of Follow-up The length of study follow-up is 3 years. Follow-up will be conducted at 2 months, 6 months, 12 months, 18 months, 24 months and 36 months.

Enrollment is expected to take approximately 4 years to complete and subjects will be followed for 36 months. It is expected the study will take approximately 7 years to complete from first subject enrollment to final clinical study report.

POP AE and Effectiveness rates, registry Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 11/15/2013 12/18/2013 Overdue/Received
1 year report 05/17/2014 05/16/2014 On Time
18 month report 11/15/2014 11/12/2014 On Time
2 year report 05/17/2015 05/18/2015 Overdue/Received
3 year report 05/16/2016 05/11/2016 On Time
4 yr report 05/16/2017 05/10/2017 On Time
5 yr report 05/30/2018 05/30/2018 On Time
6 year report 05/30/2019 05/30/2019 On Time
7 year report 05/30/2020 05/29/2020 On Time
8 year report 05/30/2021 06/02/2021 Overdue/Received
final report 02/16/2022