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

Overview

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 Title of Study: “Long-Term Effectiveness Trial for AMS Sling Systems”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2010

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.

Interventions

  • Device: MiniArc
    • sling system

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • American Medical Systems
  • Provider of Information About this Clinical Study
    • Audrey Singh- Clinical Project Lead, American Medical Systems, Inc.
  • Overall Official(s)
    • Michael Kennelly, MD, Principal Investigator, McKay Urology Research

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