OHSU

IRB #

IRB00009924

Title

Real-time Observation of Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence

Principal Investigator

William Gregory

Study Purpose

Macroplastique is an injectable soft-tissue bulking agent that is permanently implanted in the urethral wall to help prevent urine leakage. It has been approved by the U.S. Food and Drug Administration for the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency.
The purpose of this study is to look at long-term safety and effectiveness of the study device in the treatment of female SUI.

Medical Condition(s)

Stress Urinary Incontinence due to intrinsic sphincter deficiency

Eligibility Criteria

Women who are at least 18 years old with stress urinary incontinence due to intrinsic sphincter deficiency and are not planning on becoming pregnant in the next year.

Age Range

18 - None

Healthy Volunteers Needed

No

Duration of Participation

5 years

Minors Included

No

Contact

Women's Health Research Unit's confidential recruitment line:
Willow
503-494-3666

Sponsor

Uroplasty, Inc.

Recruitment End

09/30/2016

Compensation Provided

Yes

Compensation

Subjects will receive up to $1100 for time and travel related to the completion of each study visit/call. There are a total of seven visits.
•$50 following completion of treatment and/or retreatment
•$50 following completion of month 3 post procedure visit
•$200 following completion of 1 year post procedure visit
•$200 following completion of 2 year post procedure visit
•$200 following completion of 3 year post procedure visit
•$200 following completion of 4 year post procedure visit
•$200 following completion of 5 year post procedure visit
Compensation will be mailed to you at the end of each visit when all visit related materials have been collected.


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