Back to resultsThis is a Post Approval Study of Coaptite® in the Treatment of Female Urinary Incontinence
Primary Purpose
Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coaptite®
Sponsored by
About this trial
This is an interventional treatment trial for Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Coaptite
Arm Description
Outcomes
Primary Outcome Measures
Incontinence Status as Assessed by Stamey Grade Score
The Stamey grade classifies the severity stress incontinence and was calculated from the 4-day voiding diary using the four possible grades from 0-3. Grade 0: controlled urination, Grade 1: accidents with vigorous activity, for example, lifting weights, coughing, and sneezing, Grade 2: accidents with minimal activity, for example, walking and standing up, and Grade 3: accidents regardless of activity or position and that cannot be attributed to a specific activity. Higher the Stamey grade, the most severe leakage level was estimated. An average of 4 days for the final grade was recorded and rounded up, if necessary (for example, 2.5 was equal to Grade 3).
Number of Participants With One Point Improvement in Stamey Grade Scores up to Month 12
The Stamey grade classifies the severity stress incontinence and was calculated from the 4-day voiding diary using the four possible grades from 0-3. Grade 0: controlled urination, Grade 1: accidents with vigorous activity, for example, lifting weights, coughing, and sneezing, Grade 2: accidents with minimal activity, for example, walking and standing up, and Grade 3: accidents regardless of activity or position and that cannot be attributed to a specific activity. Higher the Stamey grade, the most severe leakage level was estimated. An average of 4 days for the final grade was recorded and rounded up, if necessary (for example, 2.5 was equal to Grade 3).
Number of Participants Who Had at Least One Point Improvement in Stamey Grade Scores Compared to Baseline
The Stamey grade classifies the severity stress incontinence and was calculated from the 4-day voiding diary using the four possible grades from 0-3. Grade 0: controlled urination, Grade 1: accidents with vigorous activity, for example, lifting weights, coughing, and sneezing, Grade 2: accidents with minimal activity, for example, walking and standing up, and Grade 3: accidents regardless of activity or position and that cannot be attributed to a specific activity. Higher the Stamey grade, the most severe leakage level was estimated. An average of 4 days for the final grade was recorded and rounded up, if necessary (for example, 2.5 was equal to Grade 3).
Number of Participants With Change From Baseline in Stamey Grade Scores Over Time
The Stamey grade classifies the severity stress incontinence and was calculated from the 4-day voiding diary using the four possible grades from 0-3. Grade 0: controlled urination, Grade 1: accidents with vigorous activity, for example, lifting weights, coughing, and sneezing, Grade 2: accidents with minimal activity, for example, walking and standing up, and Grade 3: accidents regardless of activity or position and that cannot be attributed to a specific activity. Higher the Stamey grade, the most severe leakage level was estimated. An average of 4 days for the final grade was recorded and rounded up, if necessary (for example, 2.5 was equal to Grade 3).
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Secondary Outcome Measures
Number of Participants Who Received Each of the Six Coaptite Injections
Coaptite injection were given to any participant during the 36 months of evaluation.
Time to Coaptite Retreatment
Time to additional coaptite treatment or any other alternative treatment for stress urinary incontinence was recorded to assess the durability of effect.
Number of Participants With Alternative Treatments for Incontinence
Number of participants with alternative treatment such as kegel exercises, sling, sling/cystocele repair, surgery, permanent abdominal tube, intravesical botox, sling/graft, sling removal, estradiol vaginal cream, bladder neck suspension, tension free vaginal tape, biofeedback, polydimethylsiloxane injections, solifenacin orally, bladder specific control physical therapy, for stress urinary incontinence were assessed.
Number of Participants With Urge Incontinence Medication (UIM) Status
The use of urge incontinence medications was collected pre-treatment and post-treatment.
Incontinence Quality of Life (iQoL) Scores
The iQoL measured the effect of urinary incontinence on QoL. It was divided into 3 subscales: 1 (avoidance and limiting behaviour); 2 (psychosocial impact), and 3 (social embarrassment). The iQOL was comprised of 22 items, each with the response scale from 1 (extremely) to 5 (not at all). A mean score for each subscale was calculated (averaging the scores for the items in each subscale) as well as a total score for all 22 items (sum of all subscale scores). The scores were then transformed to a scale score ranging from 0 to 100 points, where higher scores indicated less impact of incontinence on QoL.
Volume of Coaptite Injected Per Treatment
Mean Number of Sites Injected by Coaptite
Full Information
NCT ID
NCT00996489
First Posted
October 14, 2009
Last Updated
July 1, 2019
Sponsor
Merz North America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00996489
Brief Title
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
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 8, 2008 (Actual)
Primary Completion Date
October 26, 2015 (Actual)
Study Completion Date
November 2, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merz North America, Inc.
4. Oversight
5. Study Description
Brief Summary
This is a post approval study of Coaptite® in the treatment of female urinary incontinence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
459 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coaptite
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Coaptite®
Intervention Description
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier
Primary Outcome Measure Information:
Title
Incontinence Status as Assessed by Stamey Grade Score
Description
The Stamey grade classifies the severity stress incontinence and was calculated from the 4-day voiding diary using the four possible grades from 0-3. Grade 0: controlled urination, Grade 1: accidents with vigorous activity, for example, lifting weights, coughing, and sneezing, Grade 2: accidents with minimal activity, for example, walking and standing up, and Grade 3: accidents regardless of activity or position and that cannot be attributed to a specific activity. Higher the Stamey grade, the most severe leakage level was estimated. An average of 4 days for the final grade was recorded and rounded up, if necessary (for example, 2.5 was equal to Grade 3).
Time Frame
Baseline and Months 6, 12, 18, 24, 30, and 36
Title
Number of Participants With One Point Improvement in Stamey Grade Scores up to Month 12
Description
The Stamey grade classifies the severity stress incontinence and was calculated from the 4-day voiding diary using the four possible grades from 0-3. Grade 0: controlled urination, Grade 1: accidents with vigorous activity, for example, lifting weights, coughing, and sneezing, Grade 2: accidents with minimal activity, for example, walking and standing up, and Grade 3: accidents regardless of activity or position and that cannot be attributed to a specific activity. Higher the Stamey grade, the most severe leakage level was estimated. An average of 4 days for the final grade was recorded and rounded up, if necessary (for example, 2.5 was equal to Grade 3).
Time Frame
Baseline up to Month 12
Title
Number of Participants Who Had at Least One Point Improvement in Stamey Grade Scores Compared to Baseline
Description
The Stamey grade classifies the severity stress incontinence and was calculated from the 4-day voiding diary using the four possible grades from 0-3. Grade 0: controlled urination, Grade 1: accidents with vigorous activity, for example, lifting weights, coughing, and sneezing, Grade 2: accidents with minimal activity, for example, walking and standing up, and Grade 3: accidents regardless of activity or position and that cannot be attributed to a specific activity. Higher the Stamey grade, the most severe leakage level was estimated. An average of 4 days for the final grade was recorded and rounded up, if necessary (for example, 2.5 was equal to Grade 3).
Time Frame
Months 6, 12, 18, 24, 30, and 36
Title
Number of Participants With Change From Baseline in Stamey Grade Scores Over Time
Description
The Stamey grade classifies the severity stress incontinence and was calculated from the 4-day voiding diary using the four possible grades from 0-3. Grade 0: controlled urination, Grade 1: accidents with vigorous activity, for example, lifting weights, coughing, and sneezing, Grade 2: accidents with minimal activity, for example, walking and standing up, and Grade 3: accidents regardless of activity or position and that cannot be attributed to a specific activity. Higher the Stamey grade, the most severe leakage level was estimated. An average of 4 days for the final grade was recorded and rounded up, if necessary (for example, 2.5 was equal to Grade 3).
Time Frame
Baseline up to Months 6 and 12
Title
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Time Frame
Baseline up to Month 36
Secondary Outcome Measure Information:
Title
Number of Participants Who Received Each of the Six Coaptite Injections
Description
Coaptite injection were given to any participant during the 36 months of evaluation.
Time Frame
Baseline up to Month 36
Title
Time to Coaptite Retreatment
Description
Time to additional coaptite treatment or any other alternative treatment for stress urinary incontinence was recorded to assess the durability of effect.
Time Frame
Baseline up to Month 36
Title
Number of Participants With Alternative Treatments for Incontinence
Description
Number of participants with alternative treatment such as kegel exercises, sling, sling/cystocele repair, surgery, permanent abdominal tube, intravesical botox, sling/graft, sling removal, estradiol vaginal cream, bladder neck suspension, tension free vaginal tape, biofeedback, polydimethylsiloxane injections, solifenacin orally, bladder specific control physical therapy, for stress urinary incontinence were assessed.
Time Frame
Baseline up to Month 6 and Months 6 to 12, 12 to 18, 18 to 24, 24 to 30, 30 to 36
Title
Number of Participants With Urge Incontinence Medication (UIM) Status
Description
The use of urge incontinence medications was collected pre-treatment and post-treatment.
Time Frame
Baseline up to Month 36
Title
Incontinence Quality of Life (iQoL) Scores
Description
The iQoL measured the effect of urinary incontinence on QoL. It was divided into 3 subscales: 1 (avoidance and limiting behaviour); 2 (psychosocial impact), and 3 (social embarrassment). The iQOL was comprised of 22 items, each with the response scale from 1 (extremely) to 5 (not at all). A mean score for each subscale was calculated (averaging the scores for the items in each subscale) as well as a total score for all 22 items (sum of all subscale scores). The scores were then transformed to a scale score ranging from 0 to 100 points, where higher scores indicated less impact of incontinence on QoL.
Time Frame
Baseline and Months 6, 12, 18, 24, 30, and 36
Title
Volume of Coaptite Injected Per Treatment
Time Frame
Baseline, Baseline to Month 6 and Months 6 to 12, 12 to 18, 18 to 24, 24 to 30, 30 to 36
Title
Mean Number of Sites Injected by Coaptite
Time Frame
Baseline, Baseline to Month 6 and Months 6 to 12, 12 to 18, 18 to 24, 24 to 30, 30 to 36
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
City
Wetumpka
State/Province
Alabama
Country
United States
City
Surprise
State/Province
Arizona
Country
United States
City
Encinitas
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Oceanside
State/Province
California
Country
United States
City
Orange
State/Province
California
Country
United States
City
Templeton
State/Province
California
Country
United States
City
Celebration
State/Province
Florida
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
Saint Petersburg
State/Province
Florida
Country
United States
City
Berwyn
State/Province
Illinois
Country
United States
City
Evanston
State/Province
Illinois
Country
United States
City
Overland Park
State/Province
Kansas
Country
United States
City
Grand Rapids
State/Province
Michigan
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Akron
State/Province
Ohio
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Temple
State/Province
Texas
Country
United States
City
Mountlake Terrace
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
This is a Post Approval Study of Coaptite® in the Treatment of Female Urinary Incontinence
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