Expired Study
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Charlotte, North Carolina 28207


Purpose:

Multi-center, prospective, single arm study. Qualify patients will receive treatment for stress urinary incontinence by implantation of an AMS Sling System. The study is a long-term evaluation of effectiveness and safety associated with AMS sling systems.


Study summary:

This study is a post market study to evaluate variables of the implantation, safety, and outcomes in a representative population (SUI) indicated for AMS sling systems at various time points. The study duration is 2 year with an estimated 200 enrollment. The outcomes of the treatment will be evaluated via pad weight test, cough stress test, QoLs,and other patient administered questionnaires.


Criteria:

Inclusion Criteria: - Females 18 years or older who have confirmed SUI defined as involuntary loss of urine that occurs during physical activity, such as coughing, sneezing, laughing, or exercise. Exclusion Criteria: - Unwilling or unable to sign ICF - Unable to understand the study or has a history of non-compliance with medical devices - Contradicted for the implantation surgery due to the following: renal sufficiency, urethral diverticulum, fistula, significant prolapse conditions, pregnant, pelvic cancer, compromise immune system,vulvar pain,blood coagulation disorder, and chronic abscesses - Pelvic prolapse greater than grade 3 - Is, in the investigator's opinion, otherwise unsuitable for the study


NCT ID:

NCT00541151


Primary Contact:

Principal Investigator
Michael Kennelly, MD
McKay Urology Research


Backup Contact:

N/A


Location Contact:

Charlotte, North Carolina 28207
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 16, 2017

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