Study of Macroplastique Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence



Status:Active, not recruiting
Conditions:Psychiatric, Urology
Therapuetic Areas:Nephrology / Urology, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:10/13/2018
Start Date:January 2008
End Date:February 2022

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

The ROSE Registry will determine the long-term safety and effectiveness of Macroplastique in
the treatment of female stress urinary incontinence (SUI) due to intrinsic sphincter
deficiency (ISD).

The Rose Registry is a five-year post-market study of the safety and effectiveness of
Macroplastique in the treatment of female stress urinary incontinence due to intrinsic
sphincter deficiency.

Inclusion Criteria:

- Subject has signed written informed consent

- Subject is a female at least 18 years of age

- Subject has been diagnosed with SUI primarily due to intrinsic sphincter deficiency
(ISD)

- Subject understands all study requirements including five year follow-up schedule

- Subject is psychologically stable and suitable for intervention as determined by the
Investigator

Exclusion Criteria:

- Subject has an acute urogenital tract inflammation or infection

- Subject is pregnant or intends to become pregnant within one year

- Subject has had a sling placement within 12 weeks

- Subject has had a bulking agent treatment within 12 weeks

- Subject has a bladder neck or urethral stricture, gross utero-vaginal prolapse,
untreated detrusor instability or hyperreflexia, neuropathic bladder, or overflow
incontinence
We found this trial at
19
sites
Asheville, North Carolina 28806
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Asheville, NC
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990 Tamiami Trail North
Naples, Florida 34102
239-434-6300
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Naples, FL
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Ann Arbor, Michigan 48109
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Ann Arbor, MI
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Cheektowaga, New York 14225
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Cheektowaga, NY
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Chicago, IL
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Columbia, South Carolina 59169
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Columbia, SC
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Englewood, Colorado 80113
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Englewood, CO
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Gastonia, North Carolina 28054
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Gastonia, NC
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Irvine, CA
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Issaquah, Washington 98027
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Issaquah, WA
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Muskegon, Michigan 49444
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Muskegon, MI
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Naples, Florida 34109
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Naples, FL
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Newburgh, Indiana 47630
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Newburgh, IN
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1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
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Oklahoma City, OK
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Orange, California 92868
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Orange, CA
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San Diego, California 92093
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San Diego, CA
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Tucson, AZ
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Virginia Beach, Virginia 23462
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Virginia Beach, VA
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