EUCTR2017-000956-25-GB进行中（未招募）1 期
CELLEBRATE: An Adaptive, Two-Stage, Double-Blind, Stratified, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR with Placebo in Female Subjects with Stress Urinary Incontinence - CLBT
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 320
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- Adult female 50 to 75 years of age who has primary and moderate-to-severe symptoms of SUI (9-45 stress incontinence episodes over 3 days, as recorded in the 3-Day Diary at screening) for a duration of at least 6 months, as confirmed by subject medical history and clinical symptoms, including a focused incontinence evaluation.
- •- Must have low hypermobility of the urethra with Valsalva Q-tip = 30º.
- •- Must be willing and able to comply with the study procedures, be
- •mentally competent and able to understand all study requirements, and
- •must agree to read and sign the informed consent form prior to any
- •study-related procedures.
- •- Must have completed 100% of their screening 3-Day Diary Evening
- •- Must be willing to use acceptable methods of contraception if of childbearing potential.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 230
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •- Symptoms of only urge incontinence as confirmed by basic evaluation of etiology from a subject medical history, including a focused incontinence history.
- •- Symptoms of mixed urinary incontinence where urge incontinence is the predominant factor, defined by the 3-Day Diary as having more than 2x the number of urge leaks than stress leaks (Assessment of predominant urge incontinence is based on the medical record, physician's assessment, and a one-time 3-Day Diary).
- •- Has not previously attempted conservative treatment prior to signing the informed consent (Examples of conservative treatment include behavior modifications, bladder exercises, biofeedback, PFMT).
- •- Morbidly obese (BMI = 35).
- •- Have medically diagnosed autoimmune disease(s) or other types of immune system compromise or disorder that has the potential for an exacerbation of the symptoms that may cause the subject to become susceptible to infections, or may require systemic corticosteroid/immunosuppressive treatment during the study.
- •- Has known allergy or hypersensitivity to bovine proteins or allergens, gentamicin sulfate, DMSO, or ampicillin that medically warrants exclusion as determined by the physician.
- •- History of cancer in pelvic organs, ureters, or kidneys.
- •- Any cancer that has undergone treatment within the past 12 months.
- •- Actively undergoing treatment with stimulation neuromodulation system (sacral, tibial, or percutaneous tibial nerve stimulation) within the last 6 months or planned during the course of the study.
- •- Pregnant, lactating, or plans to become pregnant during the course of the study.
研究者
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