MiniArc Study: Long-Term Effectiveness Trial for AMS Sling Systems
This trial is active, not recruiting.
|Condition||stress urinary incontinence in women|
|Sponsor||American Medical Systems|
|Start date||September 2007|
|End date||August 2010|
|Trial size||188 participants|
|Trial identifier||NCT00541151, WC0605|
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.
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
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
Female participants at least 18 years old.
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
|Official title||Long-Term Effectiveness Trial for AMS Sling Systems|
|Principal investigator||Michael Kennelly, MD|
|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.|
Call for more information