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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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15 April 2013 |
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Main ID: |
NCT00996489 |
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Date of registration:
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14/10/2009 |
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Primary sponsor: |
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Public title:
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Post Approval Study of Coaptite® in the Treatment of Female Urinary Incontinence
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Scientific title:
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Date of first enrolment:
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November 2007 |
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Target sample size:
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450 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00996489 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Has female stress urinary incontinence that is due to intrinsic sphincter
deficiency
- 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 had a previous treatment for urinary incontinence with a urethral bulking agent
other than Coaptite® or collagen
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency
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Intervention(s)
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Device: Coaptite®
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Primary Outcome(s)
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To assess the long term effectiveness of Coaptite® using voiding diaries, recording number of and time to additional/alternative treatments,and assessing the impact of re-treatment.
[Time Frame: 3 years]
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To assess the long term safety of Coaptite® using physical exams and other diagnostic tests
[Time Frame: 3 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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