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Clinical Trial Summary

To monitor post-market performance through evaluation of short and long-term performance via:

- Efficacy

- Safety

- Patient reported outcomes


Clinical Trial Description

As this is a post-market registry on market approved devices, there will be no formal hypothesis testing. However, points of evaluation will include:

- Characterize the efficacy of the AMS market approved female pelvic health products using standard of care outcome measures and validated quality of life questionnaires

- Characterize the type, severity, and rate of adverse events related to each AMS market approved female pelvic health product

- Collect concomitant procedural data related to the pelvic floor area ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01673360
Study type Observational
Source ASTORA Women’s Health
Contact
Status Terminated
Phase N/A
Start date September 2012
Completion date December 2021

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