A Single-Masked, Randomized, Multi-Center, 2-Arm Parallel Study Comparing the Safety and Effectiveness of Bulkamid® and Contigen® as Bulking Agents for the Treatment of Stress Urinary Incontinence in Females
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 345
- 试验地点
- 68
- 主要终点
- The Number of Participants With Device- and Procedure-related Serious Adverse Events Through 12 Months Follow-up.
研究概览
简要总结
The primary purpose of this study is to demonstrate the safety and effectiveness of Bulkamid® in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) in adult women who have SUI or stress predominant mixed incontinence
详细描述
The study is a single-masked, randomized, comparative multi-center, 2-arm parallel study intended to demonstrate the safety and effectiveness of Bulkamid® vs. Contigen® for the treatment of stress urinary incontinence (SUI)due to intrinsic sphincter deficiency (ISD) in adult women who have SUI or stress predominant mixed incontinence.
Subjects will be randomized to receive either a polyacrylamide hydrogel (Bulkamid®) treatment, or a collagen treatment (Contigen®) using a 2:1 ratio and will be masked to the treatment. Screening baseline evaluations and collagen skin testing will be completed to determine eligible subjects. Following a negative skin test, a subject will be randomized and treated with Bulkamid® or the comparator device at the Treatment Visit.
Subjects that are not continent will be considered for re-injection. A maximum of 3 injections (initial + 2 re-injections) are allowed. After the last injection, subjects will attend the 3-Month, 6-Month and 12-Month Follow-up Visits plus a telephone contact at 9 months.
The study will record objective incontinence measurements, subject's perception of effectiveness and quality of life assessments. Adverse events will be recorded throughout the study.
Each subject will be followed for 12 months from the last injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Be female 18 or more years of age.
- •Females of childbearing potential or <2 years post-menopausal must be using 2 forms of contraception.
- •Suffer from SUI for at least 6 months.
- •Have failed 2 previous non-invasive therapies for 3 months each.
- •Have at least 3 incontinence episodes measured over 3 days.
- •Have a baseline 24h pad test weight greater than or equal to 5 gm.
- •Have VLPP ≤ 100 cm H2O.
- •Have maximum cystometric capacity equal or higher than (≥) 250 mL.
- •Have PVR urine ≤ 100 mL.
- •Have a life expectancy of more than 2 years.
排除标准
- •Has urethral hypermobility >30 deg.
- •Has predominant urge incontinence.
- •Has detrusor overactivity.
- •Regularly or intermittently users of urethral catheter.
- •Has had previous radiation treatment in the pelvic floor.
- •Has had previous urethral surgery (i.e. fistula, diverticula)or urethral bulking. Failed sling or colposuspension procedure for at least 6 months may be included.
- •Suffers from known polyuria.
- •Has had three (3) or more culture-proven bacterial UTIs in the last 12 months.
- •Has a current infection (urethritis, cystitis or vaginitis).
- •Has unevaluated hematuria.
- •Has a Prolapse Stage greater than II.
- •Has a BMI>35 kg/m
- •Is taking pharmacological treatment for stress urinary incontinence, 4 weeks prior to screening.
- •Is allergic to bovine collagen.
- •Is known to suffer from severe allergies or anaphylaxis.
- •Suffers from autoimmune diseases (e.e. connective tissue diseases) that could confound the treatment.
- •Is currently taking or has taken systemic corticosteroids within the past 3 months.
- •Currently has cancer or has a history of any cancer within the past 5 years (skin cancer with no evidence of skin malignancy, for at least 2 years, can be included).
- •Currently suffering from unstable cardiovascular disease, cancer or uncontrolled diabetes.
- •Has active herpes genitalis.
- •Is currently participating in any other clinical trial or has participated in another clinical trial within 3 months of screening/baseline visit.
- •Is pregnant, lactating or intending to become pregnant.
- •Is not physically able to perform study procedure.
- •Has a neurogenic bladder
- •Had a vaginal delivery within 3 months prior to screening.
结局指标
主要结局
The Number of Participants With Device- and Procedure-related Serious Adverse Events Through 12 Months Follow-up.
时间窗: 12 months
The number of participants with device- and procedure-related serious adverse events through 12 months follow-up.
Primary Effectiveness Endpoint
时间窗: 12 Months
The number of subjects with at least a 50% reduction from baseline in both leakage, as measured by the 24h Pad Test, and daily number of incontinence episodes
次要结局
- 24hr Pad Test(12 months)
- IQoL(12 months)
- Number of Subjects Reporting as a Responder(12 months)
- ICIQ-UI Short Form(12 months)
- Number of Incontinence Episodes(12 months)