Clinical trial NCT00996489: This is a Post Approval Study of Coaptite® in the Treatment of Female Urinary Incontinence
Official title: Post-approval of Coaptite® in the Treatment of Female Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-16
Enrollment: 459
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Incontinence Status as Assessed by Stamey Grade Score
timeFrame: Baseline and Months 6, 12, 18, 24, 30, and 36
measure: Number of Participants With One Point Improvement in Stamey Grade Scores up to Month 12
timeFrame: Baseline up to Month 12
measure: Number of Participants Who Had at Least One Point Improvement in Stamey Grade Scores Compared to Baseline
timeFrame: Months 6, 12, 18, 24, 30, and 36
measure: Number of Participants With Change From Baseline in Stamey Grade Scores Over Time
timeFrame: Baseline up to Months 6 and 12
measure: Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
timeFrame: Baseline up to Month 36
Secondary outcomes:
measure: Number of Participants Who Received Each of the Six Coaptite Injections
timeFrame: Baseline up to Month 36
measure: Time to Coaptite Retreatment
timeFrame: Baseline up to Month 36
measure: Number of Participants With Alternative Treatments for Incontinence
timeFrame: Baseline up to Month 6 and Months 6 to 12, 12 to 18, 18 to 24, 24 to 30, 30 to 36
measure: Number of Participants With Urge Incontinence Medication (UIM) Status
timeFrame: Baseline up to Month 36
measure: Incontinence Quality of Life (iQoL) Scores
timeFrame: Baseline and Months 6, 12, 18, 24, 30, and 36
measure: Volume of Coaptite Injected Per Treatment
timeFrame: Baseline, Baseline to Month 6 and Months 6 to 12, 12 to 18, 18 to 24, 24 to 30, 30 to 36
measure: Mean Number of Sites Injected by Coaptite
timeFrame: Baseline, Baseline to Month 6 and Months 6 to 12, 12 to 18, 18 to 24, 24 to 30, 30 to 36
Other outcomes:
Locations:
city: Wetumpka
country: United States
state: Alabama
city: Surprise
country: United States
state: Arizona
city: Encinitas
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Orange
country: United States
state: California
city: Templeton
country: United States
state: California
city: Celebration
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Berwyn
country: United States
state: Illinois
city: Evanston
country: United States
state: Illinois
city: Overland Park
country: United States
state: Kansas
city: Grand Rapids
country: United States
state: Michigan
city: Saint Louis
country: United States
state: Missouri
city: Rochester
country: United States
state: New York
city: Akron
country: United States
state: Ohio
city: Houston
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Mountlake Terrace
country: United States
state: Washington
Study officials:
References: