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

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ClinicalTrials.gov Identifier: NCT00541151
Recruitment Status : Unknown
Verified August 2010 by American Medical Systems.
Recruitment status was:  Active, not recruiting
First Posted : October 10, 2007
Last Update Posted : August 27, 2010
Sponsor:
Information provided by:
American Medical Systems

Brief 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.

Condition or disease Intervention/treatment
Stress Urinary Incontinence in Women Device: MiniArc

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.

Study Type : Observational
Actual Enrollment : 188 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-Term Effectiveness Trial for AMS Sling Systems
Study Start Date : September 2007
Estimated Primary Completion Date : August 2010
Estimated Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Device: MiniArc
    sling system
    Other Name: MiniArc or single incision sling


Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Females 18 years or older who have confirmed SUI
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00541151


Locations
United States, North Carolina
McKay Urology Research
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
American Medical Systems
Investigators
Principal Investigator: Michael Kennelly, MD McKay Urology Research

Responsible Party: Audrey Singh- Clinical Project Lead, American Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT00541151     History of Changes
Other Study ID Numbers: WC0605
First Posted: October 10, 2007    Key Record Dates
Last Update Posted: August 27, 2010
Last Verified: August 2010

Keywords provided by American Medical Systems:
Stress urinary incontinence in Women

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders