Trials / Unknown
UnknownNCT00541151
MiniArc Study: Long-Term Effectiveness Trial for AMS Sling Systems
Long-Term Effectiveness Trial for AMS Sling Systems
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 188 (actual)
- Sponsor
- American Medical Systems · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MiniArc | sling system |
Timeline
- Start date
- 2007-09-01
- Primary completion
- 2010-08-01
- Completion
- 2010-11-01
- First posted
- 2007-10-10
- Last updated
- 2010-08-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00541151. Inclusion in this directory is not an endorsement.