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

American Medical Systems

Status: Unknown

Conditions: Stress Urinary Incontinence in Women

Treatments: Device: MiniArc

Study type: Observational

Funder types: Industry

Identifiers

NCT00541151

WC0605

Details and patient eligibility

About

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.

Full 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.

Enrollment: 188 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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