MiniArc Study: Long-Term Effectiveness Trial for AMS Sling Systems

Status unconfirmed

Conditions studied: Stress Urinary Incontinence in Women

In brief

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.

Key facts

Study ID

NCT00541151

Run by

American Medical Systems

People needed

188

Starts

2007-09-01

Expected to finish

2010-11-01

Last updated by the study team

2010-08-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• McKay Urology Research — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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