Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT01673360
Brief Summary:
To monitor post-market performance through evaluation of short and long-term performance via:
* Efficacy
* Safety
* Patient reported outcomes
Detailed 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:
NCT01673360
Study Brief:
Protocol Section:
NCT01673360