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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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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 06/09/2016
Study Name POP AE and Effectiveness rates, registry
Root Document Number K092207  K103568  K053361  K041632 
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.
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: Device or procedure-related adverse events (AEs) of interest at 12 months; Secondary Effectiveness Endpoints: Recurrent prolapse at 36 months; 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.

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 05/16/2018    
Final report 07/16/2019    

  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • In May 2008, the oversight responsibility of the 522 Postmarket Surveillance Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH). DEPI continues to build the 522 program.
  • CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.


Contact Information

Cheryl Reynolds
Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002

Phone: (301) 796-6068
Fax: (301) 847-8140