Clinical Post- Approval Study of the Neuspera Sacral Neuromodulation (SNM) System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 116
- 试验地点
- 20
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
Prospective, multi-center, single-arm, post-approval study is designed to assess the long-term safety and efficacy data of the Neuspera Sacral Neuromodulation (SNM) System following commercial approval of the Neuspera SNM System.
Participants in this study received intervention/implanted in Phase I or Phase II of the Neuspera SANS_UUI (NSM-004) Study.
详细描述
The Neuspera SNM System received FDA PMA approval for the treatment of urinary urge incontinence in subjects who have failed, could not tolerate, or were not a candidate for more conservative treatment. The study will serve as the Post Approval Study (PAS) requirement of the PMA Approval.
This post approval study (PAS) is designed to assess the long-term safety and effectiveness data out to 72 months post-implant, in consenting subjects implanted in Phase I or Phase II 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
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects in the SANS-UUI Phase I or Phase II study
排除标准
- 未提供
研究组 & 干预措施
Neuspera Implantable Sacral Neuromodulation Stimulation System
Long term follow-up for the FDA approved Neuspera Sacral Neuromodulation Stimulation system
干预措施: Neuspera Implantable Sacral Neuromodulation System (Device)
结局指标
主要结局
Primary Safety Endpoint
时间窗: Through 72 months
Incidence of device- and procedure-related AEs
Primary Effectiveness Endpoint:
时间窗: Through 72 months
Percentage of all implanted subjects who experience an improvement in UUI episodes of at least 50% or more
次要结局
未报告次要终点