Study of Macroplastique Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence
NCT ID: NCT01115465
Last Updated: 2020-03-11
Study Results
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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UNKNOWN
NA
276 participants
INTERVENTIONAL
2008-01-31
2022-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Macroplastique
Macroplastique will be used for the treatment in an open-label, five year, post-market study
Macroplastique
Macroplastique is an injectable soft-tissue bulking agent used to treat stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency (ISD).
Interventions
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Macroplastique
Macroplastique is an injectable soft-tissue bulking agent used to treat stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency (ISD).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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Uroplasty, Inc
INDUSTRY
Responsible Party
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Locations
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Urological Associates of Southern Arizona
Tucson, Arizona, United States
Kaiser Permanente Southern California-Irvine Medical Center
Irvine, California, United States
Univeristy of California- Irvine
Orange, California, United States
The University of California- of San Diego
San Diego, California, United States
Urology Associates, PC
Englewood, Colorado, United States
Specialists in Urology
Naples, Florida, United States
The Florida Bladder Institute
Naples, Florida, United States
Northwestern University Prentice Women's Hospital
Chicago, Illinois, United States
Deaconess Clinic
Newburgh, Indiana, United States
The University of Michigan Health Center
Ann Arbor, Michigan, United States
Mercy Heatlh Partners at the Lakes
Muskegon, Michigan, United States
Western New York Urology
Cheektowaga, New York, United States
Western Carolina Women's Specialty Center
Asheville, North Carolina, United States
Carolina Urology Partners
Gastonia, North Carolina, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
Southern Urogynecology
Columbia, South Carolina, United States
Urology of Virginia
Virginia Beach, Virginia, United States
Athena Urology
Issaquah, Washington, United States
Countries
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Other Identifiers
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MPQ092006
Identifier Type: -
Identifier Source: org_study_id
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