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

Stopped early

Conditions studied: Female Stress Incontinence, Pelvic Organ Prolapse

In brief

To monitor post-market performance through evaluation of short and long-term performance via: * Efficacy * Safety * Patient reported outcomes

Key facts

Study ID

NCT01673360

Run by

ASTORA Women's Health

People needed

401

Starts

2012-09-01

Expected to finish

2021-12-01

Last updated by the study team

2016-06-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients must meet all of the following criteria to be considered for inclusion in the registry.
• Have a signed Informed Consent Form
• Have a signed HIPAA Authorization Form or equivalent Patient Privacy Form if required outside of the US
• Is a female at least 18 years of age
• Is scheduled to receive at least one (1) AMS market approved female pelvic health implantable product.
• Is able and willing to participate in the registry

You may not qualify if…

• Patients will be excluded from the registry if any one of the following criteria is met.
• Patients are contraindicated to receive the target AMS market approved female pelvic health product per the product's IFU

Where it is running

• Atlanta Medical Research Institute — Alpharetta, Georgia, United States
• Morristown Memorial Hospital — Morristown, New Jersey, United States
• Womancare — Winston-Salem, North Carolina, United States
• Seven Hills Women's Health Centers — Cinncinatti, Ohio, United States
• The Female Pelvic Health Center — Newtown, Pennsylvania, United States
• Female Pelvic Medicine Institute of Virginia — Richmond, Virginia, United States
• The Ottawa Hospital - Shirley E. Greenberg Women's Health Centre — Ottawa, Ontario, Canada
• Windsor Research Office — Windsor, Ontario, Canada
• CMC Beau Soleil — Montpellier, France
• Hôpital BICÊTRE — Paris, France
• German Pelvic Floor Center, St. Hedwig Hospital — Berlin, Germany
• Waldburg-Zeil Kliniken Klinik Tettnang — Tettnang, Germany
• University Medical Centre Maribor — Maribor, Slovenia
• Pretoria Urology Hospital — Pretoria, South Africa
• Hospital Clínico y Provincial de Barcelona — Barcelona, Spain
• Hospital Beata María Ana de Jesus — Madrid, Spain
• Hospital Rio Hortega — Valladolid, Spain
• Royal Bolton Hospital — Bolton, United Kingdom
• Glasgow - Southern General Hospital — Glasgow, United Kingdom

Full record on ClinicalTrials.gov

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