NCT01893138已完成3 期
A Double-blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Stress Urinary Incontinence
Cook MyoSite57 个研究点 分布在 3 个国家目标入组 311 人开始时间: 2013年11月21日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 311
- 试验地点
- 57
- 主要终点
- Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary
研究概览
简要总结
This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle-Derived Cells (generic name Iltamiocel) compared to a placebo (vehicle) control dose in the treatment of stress urinary incontinence (SUI) in adult female patients.
详细描述
Study comparing intrasphincteric injection of iltamiocel with placebo. Subjects unblinded after 12 month visits, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Female patient has primary symptoms of SUI, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation.
排除标准
- •Patient has symptoms of pure urge incontinence as confirmed by basic evaluation of etiology from a patient medical history, including a focused incontinence history.
- •Patient has symptoms of mixed urinary incontinence where urge incontinence is the predominant factor.
- •Patient has had stress urinary incontinence symptoms less than 6 months prior to signing the informed consent.
- •Patient has not previously attempted conservative treatment prior to signing the informed consent. (Examples of conservative treatment include behavior modifications, bladder exercises, biofeedback, etc.)
- •Patient has more than 2 episode of awakening to void during normal sleeping hours.
- •Patient cannot be maintained on a stable dose and/or frequency of medication (including diuretics) known to affect lower urinary tract function, including but not limited to, anticholinergics, tricyclic antidepressants or alpha-adrenergic blockers, for at least 2 weeks prior to screening or is likely to change during the course of the study.
- •Patient is pregnant, lactating, or plans to become pregnant during the course of the study.
- •Patient refuses to provide written informed consent.
- •Patient is not at least 18 years of age.
- •Patient is not available for the follow-up evaluations as required by the protocol.
结局指标
主要结局
Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary
时间窗: Baseline and 12 months
次要结局
- Participants With at ≥ 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months(Baseline and 12 months)
- Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months(Baseline and 12 months)
- Change in the Frequency of Stress Incontinence Episodes From Baseline at 12 Months(Baseline and 12 months)
研究者
研究点 (57)
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