NCT06968741招募中不适用
Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter In the treAtment of Stress Urinary Incontinence in Men
UroMems SAS1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年5月19日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Responder rate at 26 weeks post-activation
研究概览
简要总结
Prospective, multicenter, single-arm study
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects aged ≥ 22 years old
- •Able to read, comprehend and willing to sign an informed consent form
- •Primary diagnosis of stress urinary incontinence for at least 6 months, as assessed by the investigator
- •Appropriate surgical candidate with no medical or mental condition that would interfere with study procedures or confound study outcomes as assessed by the investigator
排除标准
- •Currently enrolled or plans to enroll in another investigational device or clinical drug trial or has completed an investigational study (for urinary incontinence) in the past 3 months prior to informed consent
- •Poor candidate for surgical procedures and/or anesthesia, as determined by investigator
- •Currently implanted with an Active Implantable Medical Device (AIMD)
- •Symptoms or diagnosis of urge incontinence or mixed incontinence (MI) with a predominant urgency component, as assessed by the investigator
结局指标
主要结局
Responder rate at 26 weeks post-activation
时间窗: 26 weeks
Proportion of subjects who report greater than or equal to 50% reduction in the 24 hour Pad Weight Test (PWT) at 26 weeks compared with Baseline
次要结局
未报告次要终点
研究者
研究点 (1)
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