Prospective, Non-randomized, Multicenter Clinical Evaluation of the Recharge Free Axonics SNM System (Model 4101)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 144
- 试验地点
- 16
- 主要终点
- Performance/Effectiveness - Improvement in Quality of Life scoring (OAB)
研究概览
简要总结
Multicenter, prospective, non randomized, single arm evaluation of patients with overactive bladder (OAB) and/or fecal incontinence (FI) employing the Axonics recharge free SNM System.
详细描述
A clinical evaluation to comply with new European Medical Device Regulations (EU MDR) guidelines. Multicenter, prospective, non-randomized, single arm study for OAB and/or FI to assess the safety and performance of the Food and Drug Administration (FDA) approved Axonics recharge free sacral neuromodulation (SNM) System, INS Model 4101. The product is currently marketed under the name F15.
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 overactive bladder (OAB) (urinary urgency incontinence (UUI)/ urinary frequency (UF)) or fecal incontinence (FI) who are not candidates for, or who have failed conservative treatment
- •Willing and capable to provide written informed consent and agrees to comply with specified evaluations at clinical investigational sites and attend all follow-up assessments for up to 1 year.
排除标准
- •Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (exclusion of 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
Single Arm - Treatment Groups separated into OAB and FI
Treatment Arm separated into 2 cohorts:
- Overactive Bladder (OAB)
- Fecal incontinence (FI)
干预措施: Axonics SNM System (Model 4101) (Device)
结局指标
主要结局
Performance/Effectiveness - Improvement in Quality of Life scoring (OAB)
时间窗: 3 months
International Consultation on Incontinence Questionnaire Overactive Bladder Quality 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.
Performance/Effectiveness - Improvement in Fecal Incontinence Survey
时间窗: 3 months
Cleveland Clinic Florida - Fecal Incontinence Score (CCF-FIS): includes 5 items (solid, liquid, gas, wears pad and lifestyle alteration) and 5 frequencies (never = 0, rarely = 1, sometimes = 2, usually = 3, always = 4). Scores range from 0 for full continence to 20 for complete incontinence. A higher score is indicative of the severity of fecal incontinence.
Adverse event reporting (Safety)
时间窗: 3 months
Device-related, procedure-related and all serious adverse events
Performance/Effectiveness - Improvement in Quality of Life scoring (OAB)
时间窗: 3 months
International Consultation on Incontinence Questionnaire Overactive Bladder Quality 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.
Performance/Effectiveness - Improvement in Fecal Incontinence Survey
时间窗: 3 months
Cleveland Clinic Florida - Fecal Incontinence Score (CCF-FIS): includes 5 items (solid, liquid, gas, wears pad and lifestyle alteration) and 5 frequencies (never = 0, rarely = 1, sometimes = 2, usually = 3, always = 4). Scores range from 0 for full continence to 20 for complete incontinence. A higher score is indicative of the severity of fecal incontinence.
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 Quality of Life scoring (OAB)(1 year)
- Performance/Effectiveness - Improvement in Fecal Incontinence Survey(1 year)
- Adverse event reporting (Safety)(1 year)
- Performance/Effectiveness - Improvement in Quality of Life scoring (OAB)(1 year)
- Adverse event reporting (Safety)(1 year)
- Performance/Effectiveness - Improvement in Fecal Incontinence Survey(1 year)
- Performance/Effectiveness - Improvement in Quality of Life Survey (FI)(3 months, 6 months, 1 year)