This is a Post Approval Study of Coaptite® in the Treatment of Female Urinary Incontinence

Completed · Not applicable

Conditions studied: Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency

In brief

This is a post approval study of Coaptite® in the treatment of female urinary incontinence.

Key facts

Study ID

NCT00996489

Run by

Merz North America, Inc.

People needed

459

Starts

2008-01-08

Expected to finish

2015-11-02

Last updated by the study team

2019-07-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Wetumpka, Alabama, United States
• Study site — Surprise, Arizona, United States
• Study site — Encinitas, California, United States
• Study site — Los Angeles, California, United States
• Study site — Oceanside, California, United States
• Study site — Orange, California, United States
• Study site — Templeton, California, United States
• Study site — Celebration, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Berwyn, Illinois, United States
• Study site — Evanston, Illinois, United States
• Study site — Overland Park, Kansas, United States
• Study site — Grand Rapids, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — Rochester, New York, United States
• Study site — Akron, Ohio, United States
• Study site — Houston, Texas, United States
• Study site — Temple, Texas, United States
• Study site — Mountlake Terrace, Washington, United States

Full record on ClinicalTrials.gov

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