Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency Clinical Trial
Official title:
Post-approval of Coaptite® in the Treatment of Female Urinary Incontinence
| Verified date | January 2019 |
| Source | Merz North America, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a post approval study of Coaptite® in the treatment of female urinary incontinence.
| Status | Completed |
| Enrollment | 459 |
| Est. completion date | November 2, 2015 |
| Est. primary completion date | October 26, 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Merz North America, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | Baseline up to Month 36 | ||
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | ||
| Secondary | 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 |