Post-Market Clinical Follow-up Study of the Rechargeable Axonics SNM System Model 5101 (R20) for the Indication of Overactive Bladder (OAB)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 7
- 主要终点
- Performance/Effectiveness - Improvement in Qualify of Life scoring (OAB)
研究概览
简要总结
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the Axonics SNM System INS Model 5101.
详细描述
This post-market clinical follow-up (PMCF) is conducted to assess the continued safety, device performance, and clinical benefit of the rechargeable Axonics SNM System INS Model 5101 also referred to as R20.
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
- •18 years or older
- •Primary indication of OAB (urinary urgency incontinence (UUI) / urinary frequency (UF) who are not candidates for, or who have failed conservative treatment
- •Willing and capable to provide written consent and agrees to comply with specified evaluations at clinical centers for all follow-up assessments
排除标准
- •Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (i.e., neurological conditions such as multiple sclerosis)
- •Any psychiatric or personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may include poor understanding or compliance with requirements
- •Previously underwent an external sacral neuromodulation SNM trial and was deemed a non-responder or was previously implanted with a sacral neuromodulation device and did not get therapeutic benefit (a non-responder)
- •History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
- •A female who is breastfeeding
- •A female with a positive urine pregnancy test
研究组 & 干预措施
Overactive Bladder
Participants with the Axonics SNM System Model 5101 and followed up regarding their overactive bladder symptoms.
干预措施: Axonics SNM System INS Model 5101 (R20) (Device)
结局指标
主要结局
Performance/Effectiveness - Improvement in Qualify of Life scoring (OAB)
时间窗: 3 months
To demonstrate an improvement in Overactive Bladder Quality of Life using the International Consultation of Incontinence Questionnaire Overactive Bladder Qualify of Life (ICIQ-OABqol): questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is indicative of a clinically meaningful improvement.
Adverse event reporting (Safety)
时间窗: 3 months
Device related, procedure-related and all serious adverse events
次要结局
- Performance/Effectiveness - Improvement in Qualify of Life scoring (OAB)(12 months)
- Performance/Effectiveness - Improvement in Qualify of Life scoring (FI)(12 months)