Post-approval of Coaptite® in the Treatment of Female Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 459
- 试验地点
- 20
- 主要终点
- Number of Participants Who Had at Least One Point Improvement in Stamey Grade Scores Compared to Baseline
研究概览
简要总结
This is a post approval study of Coaptite® in the treatment of female urinary incontinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Coaptite
干预措施: Coaptite® (Device)
结局指标
主要结局
Number of Participants Who Had at Least One Point Improvement in Stamey Grade Scores Compared to Baseline
时间窗: Months 6, 12, 18, 24, 30, and 36
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)
时间窗: Baseline up to Month 36
Incontinence Status as Assessed by Stamey Grade Score
时间窗: Baseline and Months 6, 12, 18, 24, 30, and 36
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
时间窗: Baseline 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 With Change From Baseline in Stamey Grade Scores Over Time
时间窗: Baseline up to Months 6 and 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).
次要结局
- Time to Coaptite Retreatment(Baseline up to Month 36)
- Incontinence Quality of Life (iQoL) Scores(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)
- Number of Participants Who Received Each of the Six Coaptite Injections(Baseline up to Month 36)
- Number of Participants With Alternative Treatments for Incontinence(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(Baseline up to Month 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)