• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

  • Print
  • Share
  • E-mail
-
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

DIVISION OF EPIDEMIOLOGY

"PROTECTING & PROMOTING PUBLIC HEALTH THROUGH DEVICE SURVEILLANCE AND RESEARCH"



WELCOME TO THE 522 POSTMARKET SURVEILLANCE STUDIES WEBPAGE

 

 

 

 

            

AE and effectiveness rates


Suggest Enhancement / Report Issue | Export to ExcelExport to Excel
General
522 Number / Requirement Number PS130039 / PSS001
Current Plan Approved 09/23/2014
Study Name AE and effectiveness rates
Root Document Number K121562 
General Study Protocol Parameters
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21, Other reason
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
new 6 month report 03/24/2015 03/18/2015 On Time
one year report 09/23/2015    
18 month report 03/23/2016    
two year report 09/22/2016    
3 yr report 09/22/2017    
4 yr report 09/22/2018    
5 yr report 09/22/2019    
Final Report 03/15/2020    


  • 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.

Links

Contact Information

Cheryl Reynolds
Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4108
Silver Spring, MD 20993-0002

Phone: (301) 796-7033
Fax: (301) 847-8140
Cheryl.Reynolds@fda.hhs.gov
-
-