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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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SUI AE and Effectiveness rates

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Study Status Progress Adequate
522 Number / Requirement Number PS120093 / PSS001
Date Current Plan Accepted 08/29/2016
Study Name SUI AE and Effectiveness rates
Root Document Number K081275 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
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, non-randomized, parallel cohort, multi-center study to examine whether the single incision sling will be non-inferior to the standard outside-in transobturator sling for the treatment of female stress urinary incontinence in safety and effectiveness 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 SUI, or a mesh complication.

Sample Size A total of 280 subjects (140 patients treated with Solyx Single Incision Sling System and 140 patients treated with Obtryx II Sling System as controls) will be enrolled at up to 30 study centers.
Data Collection Primary Endpoint: Improvement in stress urinary incontinence at 36 months as compared to Baseline, by a composite of objective and subjective measures. Secondary Endpoints: 1. Incidence of mesh erosion (vaginal or urethral); 2. Incidence of mesh exposure; 3. Incidence of de novo dyspareunia; 4. Improvement of leakage on Urogenital Distress Inventory (UDI) Questionnaire; 5. Improvement in subject specific outcomes ((Pelvic Impact Sexual (PISQ) Questionnaire, Incontinence Severity Index (ISI), Pelvic Floor Impact Questionnaire (PFIQ-7)); 6. Assessment of pain scores, measured by the Visual Analog Scale (VAS); 7. Assessment of subject's level of improvement, measured by the Global Impression of Improvement (PGI-I); 8. Time to spontaneously void; 9. Assessment of re-intervention and re-surgery for recurrence or persistence of SUI or mesh exposure/erosion.
Follow-up Visits and Length of Follow-up The length of study follow-up is 3 years. Follow-up will be conducted at 2 weeks, 6 weeks, 6 months, 12 months, 18 months, 24 months and 36 months. For each of the primary endpoint and serious adverse events, non-inferiority of the single-incision sling will be evaluated using a two-sided 90% confidence interval for the treatment difference (single-incision minus transobturator). The confidence interval will be calculated based on the pooling of treatment differences across propensity score strata. All statistical analyses will be performed by the sponsor per the statistical analysis plan. All analyses will be done using SAS (version 8.0 or higher) statistical software. Subject summary tables and data listings will be provided for the data collected.

Propensity score stratification will be used to adjust baseline characteristics (including patient based risk factors and site based risk factors) between treatment and control groups. Non-inferiority paired test will be used to test categorical data such as serious device or serious procedure related AEs including mesh-related complications between the two groups after matching. If the upper limit of the confidence interval for the difference between two groups is smaller than ¿, non-inferiority is claimed. Paired t-test for non-inferiority will be used to test continuous data including QOL score improvements between two groups after matching.

SUI AE and Effectiveness rates Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 08/01/2013 08/01/2013 On Time
1 yr report 01/31/2014 01/31/2014 On Time
18 month report 08/01/2014 07/31/2014 On Time
2 yr report 01/31/2015 02/02/2015 Overdue/Received
3 yr report 01/31/2016 01/29/2016 On Time
4 yr report 01/30/2017 01/30/2017 On Time
Final report 06/29/2018    

  • 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