EUCTR2011-003599-35-BE进行中（未招募）1 期
A Double blind, Randomized, Placebo-Controlled Study Evaluating theSafety and Effectiveness of Cook MyoSite Incorporated AMDC in FemalePatients with Stress Urinary Incontinence - UIAD
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 246
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
- •The patient is female and has primary symptoms of SUI, as confirmed
- •by patient medical history and clinical symptoms, including a focused
- •incontinence evaluation
- •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 184
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 62
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 for at
- •least 1 month 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 randomization 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.
研究者
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