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

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

Official Title
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Post-approval of Coaptite® in the Treatment of Female Urinary Incontinence

Conditions
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Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency

Intervention / Treatment
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* Device: Coaptite®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coaptite<br> | Device: Coaptite®<br>* Calcium hydroxylapatite particles suspended in an aqueous based gel carrier<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline and Months 6, 12, 18, 24, 30, and 36 | 
| 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). | Baseline up to Month 12 | 
| 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). | Months 6, 12, 18, 24, 30, and 36 | 
| 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). | Baseline up to Months 6 and 12 | 
| Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) |  | Baseline up to Month 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Received Each of the Six Coaptite Injections | Coaptite injection were given to any participant during the 36 months of evaluation. | Baseline up to Month 36 | 
| 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. | Baseline up to Month 36 | 
| 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. | Baseline up to Month 6 and Months 6 to 12, 12 to 18, 18 to 24, 24 to 30, 30 to 36 | 
| Number of Participants With Urge Incontinence Medication (UIM) Status | The use of urge incontinence medications was collected pre-treatment and post-treatment. | Baseline up to Month 36 | 
| 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. | Baseline and Months 6, 12, 18, 24, 30, and 36 | 
| Volume of Coaptite Injected Per Treatment |  | Baseline, Baseline to Month 6 and Months 6 to 12, 12 to 18, 18 to 24, 24 to 30, 30 to 36 | 
| Mean Number of Sites Injected by Coaptite |  | Baseline, Baseline to Month 6 and Months 6 to 12, 12 to 18, 18 to 24, 24 to 30, 30 to 36 |