Status:
COMPLETED
This is a Post Approval Study of Coaptite® in the Treatment of Female Urinary Incontinence
Lead Sponsor:
Merz North America, Inc.
Conditions:
Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This is a post approval study of Coaptite® in the treatment of female urinary incontinence.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 8 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2015
Estimated Enrollment :
459 Patients enrolled
Trial Details
Trial ID
NCT00996489
Start Date
January 8 2008
End Date
November 2 2015
Last Update
July 23 2019
Active Locations (20)
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1
Wetumpka, Alabama, United States
2
Surprise, Arizona, United States
3
Encinitas, California, United States
4
Los Angeles, California, United States