NCT01673360

Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 401 (actual)
• Sponsor: ASTORA Women's Health · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Female Stress Incontinence
• Pelvic Organ Prolapse

Interventions

Type	Name	Description
DEVICE	Elevate PC	List of AMS prolapse products
DEVICE	Mini Arc Pro	List of AMS Urinary Incontinence devices
DEVICE	RetroArc	List of AMS Urinary Incontinence devices

Timeline

• Start date: 2012-09-01
• Primary completion: 2020-12-01
• Completion: 2021-12-01
• First posted: 2012-08-28
• Last updated: 2016-06-17

Locations

19 sites across 8 countries: United States, Canada, France, Germany, Slovenia, South Africa, Spain, United Kingdom