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

August 26, 2010 updated by: American Medical Systems

Long-Term Effectiveness Trial for AMS Sling Systems

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Actual)

188

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • McKay Urology Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Females 18 years or older who have confirmed SUI

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American Medical Systems

Investigators

  • Principal Investigator: Michael Kennelly, MD, McKay Urology Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Anticipated)

August 1, 2010

Study Completion (Anticipated)

November 1, 2010

Study Registration Dates

First Submitted

October 5, 2007

First Submitted That Met QC Criteria

October 5, 2007

First Posted (Estimate)

October 10, 2007

Study Record Updates

Last Update Posted (Estimate)

August 27, 2010

Last Update Submitted That Met QC Criteria

August 26, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WC0605

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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