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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by American Medical Systems.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
American Medical Systems
ClinicalTrials.gov Identifier:
NCT00541151
First received: October 5, 2007
Last updated: August 26, 2010
Last verified: August 2010
  Purpose

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 Intervention Phase
Stress Urinary Incontinence in Women
Device: MiniArc
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-Term Effectiveness Trial for AMS Sling Systems

Resource links provided by NLM:


Further study details as provided by American Medical Systems:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Enrollment: 188
Study Start Date: September 2007
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: MiniArc
    sling system
    Other Name: MiniArc or single incision sling
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Audrey Singh- Clinical Project Lead, American Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT00541151     History of Changes
Other Study ID Numbers: WC0605
Study First Received: October 5, 2007
Last Updated: August 26, 2010
Health Authority: United States: Western Institutional Review Board and Local Institution Review Boards
UK: South Glasgow and Clyde Research Ethics Committee
Europe: Commissie voor Medische Ethiek Klinisch Onderzoek
Canada:VIHA ethics committee

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

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

ClinicalTrials.gov processed this record on November 20, 2014