Long-Term Effectiveness Trial for AMS Sling Systems(MiniArc Study) - Full Text View

Sponsored by:	American Medical Systems
Information provided by:	American Medical Systems
ClinicalTrials.gov Identifier:	NCT00541151

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 IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Long-Term Effectiveness Trial for AMS Sling Systems

Resource links provided by NLM:

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence

U.S. FDA Resources

Further study details as provided by American Medical Systems:

Primary Outcome Measures:

functional improvement of a patient after implantation of the AMS Sling System via qualitative(UDI-6)and quantitative measurement(pad weight test) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessment of: safety, qualify of life, intraoperative parameters, urethral hypermobility, and recovery time. These endpoints will be measured via questionnaires, Q-tip test,and report of adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Intervention Details:

sling system

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, Q-tip test, and other patient administered questionnaires.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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
Is, in the investigator's opinion, otherwise unsuitable for the study

Contacts and Locations

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:	McKay Urology ( Michael Kennelly, M.D. )
Study ID Numbers:	WC0605
Study First Received:	October 5, 2007
Last Updated:	June 12, 2009
ClinicalTrials.gov Identifier:	NCT00541151 History of Changes
Health Authority:	United States: WIRB(central IRB)Institutional Review Board and Local Institution Board; 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

Study placed in the following topic categories:

Signs and Symptoms
Urinary Incontinence, Stress
Urologic Diseases

Urination Disorders
Stress
Urinary Incontinence

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Urinary Incontinence, Stress

Urologic Diseases
Urination Disorders
Urinary Incontinence

ClinicalTrials.gov processed this record on August 28, 2009