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

Merz Pharmaceuticals

Status: Completed

Conditions: Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency

Treatments: Device: Coaptite®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00996489

P1005185

Details and patient eligibility

About

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

Enrollment: 459 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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459 participants in 1 patient group

Coaptite

Experimental group

Treatment:

Device: Coaptite®