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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MiniArc | Device | sling system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of long-term effectiveness after implantation of MiniArc sling via qualitative(i.e.UDI-6 and IIQ-7) and quantitative measurement (i.e.pad weight test and cough stress test) in females for treatment of SUI in general post-market use. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of procedural variables of the implantation,outcomes,and long-term safety.These outcomes will be measured via questionnaires, procedural data, and report of adverse events. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Females 18 years or older who have confirmed SUI
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| Name | Affiliation | Role |
|---|---|---|
| Michael Kennelly, MD | McKay Urology Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McKay Urology Research | Charlotte | North Carolina | 28207 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 22, 2016 | |
| Reset | Aug 26, 2016 | |
| Release | Aug 29, 2016 | |
| Reset | Oct 25, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 22, 2016 | Aug 26, 2016 | |||
| Aug 29, 2016 |
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| Oct 25, 2016 |