This is a Post Approval Study of Coaptite® in the Treatment of Female Urinary Incontinence
NCT ID: NCT00996489
Last Updated: 2019-07-23
Study Results
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View full resultsBasic Information
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COMPLETED
NA
459 participants
INTERVENTIONAL
2008-01-08
2015-11-02
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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Coaptite
Coaptite®
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier
Interventions
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Coaptite®
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier
Eligibility Criteria
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Inclusion Criteria
* Has a baseline pad weight of greater than or equal to 50 grams
* Has viable mucosal lining at likely site of injection (bladder neck)
* Is at least 18 years of age
* Understands and accepts the obligation and is logistically able to present for all scheduled study visits
* Signs written informed consent
Exclusion Criteria
* Has detrusor instability
* Has bladder neuropathy
* Has nocturnal enuresis (bed wetting)
* Has Grade II or III prolapsed bladder
* Has overflow or functional incontinence
* Has significant history of urinary tract infections without resolution
* Has current or acute conditions of cystitis or urethritis
* Has history of significant pelvic irradiation
* Is pregnant or lactating
18 Years
FEMALE
No
Sponsors
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Merz North America, Inc.
INDUSTRY
Responsible Party
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Locations
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Wetumpka, Alabama, United States
Surprise, Arizona, United States
Encinitas, California, United States
Los Angeles, California, United States
Oceanside, California, United States
Orange, California, United States
Templeton, California, United States
Celebration, Florida, United States
Orlando, Florida, United States
St. Petersburg, Florida, United States
Berwyn, Illinois, United States
Evanston, Illinois, United States
Overland Park, Kansas, United States
Grand Rapids, Michigan, United States
St Louis, Missouri, United States
Rochester, New York, United States
Akron, Ohio, United States
Houston, Texas, United States
Temple, Texas, United States
Mountlake Terrace, Washington, United States
Countries
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Other Identifiers
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P1005185
Identifier Type: -
Identifier Source: org_study_id
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