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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

188 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stress Urinary Incontinence in Women

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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MiniArc

sling system

Intervention Type DEVICE

Other Intervention Names

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MiniArc or single incision sling

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No