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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 Other
522 Number / Requirement Number PS120035 / PSS001
Date Current Plan Accepted 06/20/2014
Study Name POP AE and Effectiveness rates, registry
Root Document Number K083499  K112386 
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 "The proposed study is a multicenter, non-randomized, cohort study of Exair for the treatment of transvaginal repair of POP among patients with clinically documented POP and symptomatic POP. The primary study hypothesis is that at 36 months following surgical treatment for POP, the proportion of prolapse recurrence (defined as prolapse below the hymenal ring or awareness of protrusion or bulge of any compartment or retreatment, including the introduction of a pessary after index procedure of Pelvic Organ Prolapse in the target compartment) in the Exair Group will be non-inferior to the proportion of prolapse recurrence in the NTR group. There is no comparator device that will be used for this study. The study will be comparing

Exair/NovaSilk mesh to native tissue repair for the treatment of pelvic organ prolapse. The native tissue repair cohort will be a shared common control cohort across multiple sponsors that are participating in the national registry. Common inclusion and exclusion criteria as well as post-hoc analyses will ensure consistency and poolability across the shared cohort."

Study Population Description The study population will consist of adult female subjects with pelvic organ prolapse that are clinically indicated for surgical intervention for pelvic floor reconstruction.
Sample Size 338 subjects (169 patients treated with Exair Anterior and Posterior Prolapse Repair Systems and 169 patients treated with Native Tissue Repair) will be enrolled at up to 25 study centers.
Data Collection Primary effectiveness endpoint: Recurrent prolapse; Primary Safety Endpoint: Device or procedure-related adverse events (AEs) of interest; Secondary Endpoints: 1. Rates of all other adverse events; 2. Primary and secondary safety endpoints stratified by compartment; 3. Primary and secondary safety endpoints listed by severity; 4. Primary and secondary efficacy outcome 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; 12. Recurrent prolapse.
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 01/06/2014 01/07/2014 Overdue/Received
1 year report 07/08/2014 07/02/2014 On Time
18 month report 01/06/2015 12/23/2014 On Time
2 year report 07/08/2015 07/06/2015 On Time
final report 04/06/2016 04/06/2016 On Time

  • 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