MiniArc Study: Long-Term Effectiveness Trial for AMS Sling Systems
Recruitment status was Active, not recruiting
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Long-Term Effectiveness Trial for AMS Sling Systems|
- 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- 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. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2007|
|Estimated Study Completion Date:||November 2010|
|Estimated Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
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.
|United States, North Carolina|
|McKay Urology Research|
|Charlotte, North Carolina, United States, 28207|
|Principal Investigator:||Michael Kennelly, MD||McKay Urology Research|