A Prospective Study to Assess the Efficacy and Safety of the BlueWind RENOVA iStim™ System in the Treatment of Patients Diagnosed With Overactive Bladder (OASIS - OverActive Bladder StImulation System Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 282
- 试验地点
- 41
- 主要终点
- ≥50% Decrease in Mean Urinary Urgency Incontinence (UUI) Episodes
研究概览
简要总结
The OASIS study is prospective, interventional, multi-center study to evaluate the safety and efficacy of the BlueWind RENOVA iStim™ implantable tibial neuromodulation System for the treatment of patients diagnosed with overactive bladder.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged 18 or greater (21 in the US)
- •More than or equal to 6 months history of UUI diagnosis
- •Patient who is mentally competent with the ability to understand and comply with the requirements of the study
排除标准
- •Any significant medical condition that is likely to interfere with study procedures
- •Patients who are breastfeeding
- •Predominant stress incontinence
- •Have a life expectancy of less than 1 year
- •Diagnosis of interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines
结局指标
主要结局
≥50% Decrease in Mean Urinary Urgency Incontinence (UUI) Episodes
时间窗: 6 months
Proportion of responders at 6 months post system activation as demonstrated by ≥50% improvement in average number of urgency related incontinence episodes, measured by 7-day Patient Voiding Diary.
Safety - Number of Participants With Adverse Events
时间窗: 12 months
The primary safety endpoint was to assess adverse events from implantation to 12-months post-activation (Treatment Emergent Adverse Events).
≥50% Decrease in Mean Urinary Urgency Incontinence (UUI) Episodes
时间窗: 6 months
Proportion of responders at 6 months post system activation as demonstrated by ≥50% improvement in average number of urgency related incontinence episodes, measured by 7-day Patient Voiding Diary.
Safety - Number of Participants With Adverse Events
时间窗: 12 months
The primary safety endpoint was to assess adverse events from implantation to 12-months post-activation (Treatment Emergent Adverse Events).
次要结局
未报告次要终点