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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 Inadequate
522 Number / Requirement Number PS130044 / PSS001
Date Current Plan Accepted 02/23/2016
Study Name POP AE and Effectiveness rates, registry
Root Document Number K122459 
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 non-randomized, parallel cohort, multi-center study to evaluate the safety and effectiveness of mesh over native tissue repair at 36 months as compared to baseline.

Study Population Description Subjects who undergo a medical intervention (surgical or non-surgical) to treat recurrence,

persistence of pelvic organ prolapse or a mesh complication.

Sample Size A total of 414 subjects (207 patients treated with Uphold LITE Vaginal Support System and

207 patients treated with Native Tissue Repair as controls) will be enrolled at up to 40 study centers

Data Collection Primary Endpoint: 1. Achieve superiority of mesh over native tissue repair at 36 months as

compared to baseline; 2. Achieve non-inferiority of mesh to native tissue repair for safety by comparing rates of serious device or serious procedure-related complications between baseline and the 36 month time point. Secondary Endpoints: 1. Incidence of mesh erosion; 2. Incidence of mesh exposure; 3. Incidence of de novo dyspareunia; 4. Improvement in subject specific outcomes at 36 months compared to Baseline (pelvic floor symptoms (PFDI-20), QOL (PFIQ-7), change in sexual functioning (PISQ-12), TOMUS pain scale); 5. Assessment of subject's level of improvement, measured by the Patient Global Impression of Improvement for Prolapse (PGI-I for Prolapse); 6. Absence of re-intervention or re-surgery for recurrence or persistence of POP or mesh exposure/erosion; 7. Surgical success; 8. Device or procedure- related incidence of the following: pelvic pain, infection, vaginal shortening, atypical vaginal discharge, neuromuscular problems, vaginal scarring, de novo vaginal bleeding, fistula formation and/or de novo voiding dysfunction.

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 03/12/2014 03/24/2014 Overdue/Received
1 Year Report 09/11/2014 09/10/2014 On Time
18 month report 03/12/2015 03/12/2015 On Time
2 Year Report 09/11/2015 09/10/2015 On Time
3 Year Report 09/10/2016 09/09/2016 On Time
4 yr report 09/10/2017 09/08/2017 On Time
5 yr report 09/10/2018    

  • 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