NL-OMON55598招募中不适用
A prospective study to assess the efficacy and safety of the BlueWind RENOVA iStim* System for the treatment of patients diagnosed with overactive bladder (OASIS - OverActive bladder StImulation System study) - BlueWind RENOVA iStim* System for the treatment of OAB
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •2 - Female aged 18 or greater (21 or greater in the US), with no plans to
- •become pregnant
- •during the trial; if of bearing potential, negative pregnancy test and
- •if sexually active, using
- •acceptable contraception.
- •4 - Diagnosis of UUI demonstrated on a 7-consecutive days voiding diary
- •a minimum of nine (9) leaking episodes associated with urgency with at
- •least one episode per
- •day for 5 days.
- •5 - More than or equal to 6 months history of UUI diagnosis
- •6 - Patient with inadequate response to any of the following conservative
- •treatments (i.e.
- •dietary restriction, fluid restriction, bladder training, behavioral
- •modification, pelvic muscle
- •training, biofeedback, etc.) and pharmacologic treatment.
排除标准
- •1 - Previous participation in another study with any investigational drug or
- •within the past 90 days
- •5 - Any significant medical condition that is likely to interfere with study
- •procedures,
- •device operation, or likely to confound evaluation of study endpoints
- •19 - More than minimal level of stress incontinence or mixed incontinence
- •with stress
- •component likely to confound study outcome, based on a 7-day voiding
- •diary or medical history,or when stress incontinence score in the MESA
- •incontinence questionnaire is higher than the urgency incontinence score
- •28 - Have a life expectancy of less than 1 year
研究者
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