MiniArc Study: Long-Term Effectiveness Trial for AMS Sling Systems
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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]
Secondary Outcome Measures
- 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]
Eligibility Criteria
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:
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Unwilling or unable to sign ICF
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Unable to understand the study or has a history of non-compliance with medical devices
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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
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Pelvic prolapse greater than grade 3
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Is, in the investigator's opinion, otherwise unsuitable for the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | McKay Urology Research | Charlotte | North Carolina | United States | 28207 |
Sponsors and Collaborators
- American Medical Systems
Investigators
- Principal Investigator: Michael Kennelly, MD, McKay Urology Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WC0605