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



Status:Terminated
Conditions:Women's Studies, Women's Studies, Urology
Therapuetic Areas:Nephrology / Urology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:6/18/2016
Start Date:September 2012
End Date:December 2021

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

- Efficacy

- Safety

- Patient reported outcomes

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

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
7
sites
Alpharetta, Georgia 30005
1920
mi
from 91732
Alpharetta, GA
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Cinncinatti, Ohio 45242
1880
mi
from 91732
Cinncinatti, OH
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100 Madison Ave
Morristown, New Jersey 7960
(973) 971-5000
Morristown Memorial Hospital Atlantic Health System – comprised of Morristown Medical Center, Overlook Medical Center,...
2407
mi
from 91732
Morristown, NJ
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Newtown, Pennsylvania 18940
2386
mi
from 91732
Newtown, PA
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2349
mi
from 91732
Ottawa,
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2268
mi
from 91732
Richmond, VA
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Winston-Salem, North Carolina 27103
2126
mi
from 91732
Winston-Salem, NC
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