NCT07456865招募中不适用
Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 256
- 试验地点
- 14
- 主要终点
- Primary Endpoint
研究概览
简要总结
The purpose of this prospective, multicenter study is to assess the long-term safety and effectiveness of the Altaviva™ system for the treatment of UUI
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidate for Altaviva™ therapy per Altaviva™ labeling
- •Have a diagnosis of UUI as demonstrated on a 3-day voiding diary by having a minimum of 3 episodes of urinary urge incontinence in 72 hours
- •If taking OAB medications, subjects should be on a stable dose for at least 3 months prior to baseline and willing to remain on stable treatment through completion of the 12-month voiding diary
- •Patient must be willing and able to accurately complete study questionnaires, attend visits, operate the system, and comply with the study protocol
- •Willing and able to provide signed and dated informed consent
排除标准
- •Patient who is not a candidate for Altaviva™ therapy per Altaviva™ labeling, including:
- •Patients who are considered to be poor surgical candidates or who are at risk for poor wound healing per Altaviva™ labeling
- •Have progressive, systemic neurological disease
- •Have clinically significant peripheral neuropathy in the lower leg
- •Severe, uncontrolled diabetes
- •Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component based on physician judgment
- •Current symptomatic urinary tract infection
- •Patients who have been treated with percutaneous tibial nerve stimulation (PTNS)/percutaneous tibial neuromodulation (PTNM) therapy in the past 4 weeks, or longer if the investigator judges that the therapeutic effect is still present
- •Patients who have had treatment of urinary symptoms with botulinum toxin therapy or sacral neuromodulation in the past 6 months
- •History of a prior implantable tibial neuromodulation system
- •Patients who are pregnant or planning to become pregnant during the course of the study
- •Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound study results
结局指标
主要结局
Primary Endpoint
时间窗: 60 months
The primary endpoint is the UUI responder rate, which is defined as the proportion of subjects experiencing at least 50% improvement in daily UUI compared to baseline. The UUI responder rate will be measured annually through 60 months.
次要结局
未报告次要终点
研究者
研究点 (14)
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