Sacral Neuromodulation for Male Overactive Bladder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 28
- 主要终点
- Adverse event reporting (Safety)
研究概览
简要总结
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
详细描述
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients who have a prior history of radical prostatectomy or radiation for prostate cancer or who have a history of cytoreductive surgical intervention for benign prostatic hyperplasia (BPH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- Male
- 接受健康志愿者
- 否
入选标准
- •Participants aged ≥ 18 years at the time of enrollment
- •Able to complete bladder diaries and patient questionnaires
- •Primary diagnosis of OAB (urinary urgency incontinence (UUI) or urinary frequency (UF)).
- •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 patient that is not a suitable candidate per investigator discretion
- •Recent prostate therapy or procedure within the last 6 months at the time of enrollment
- •Any neurological condition that could interfere with normal bladder function, including stroke, epilepsy, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia)
- •Previously implanted with a sacral neuromodulation device, including inactive SNM devices
- •Any prior treatment with an Implantable Tibial Nerve Stimulation (ITNS)
- •Positive response to Percutaneous Tibial Nerve Stimulation (PTNS) within the last 3 months at the time of enrollment
- •Underwent an external trial with any sacral neuromodulation device and was deemed a non-responder by a physician
- •Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study objectives at the discretion of the participating physician.
- •Uncontrolled diabetes
- •Known allergic reactions to components of the Axonics SNM System, including titanium, zirconia, polyurethane, epoxy, or silicone
研究组 & 干预措施
Radiation
History of radiation for cancer treatment at least 6 months prior to enrollment
干预措施: Axonics SNM System (Device)
Post-prostatectomy
History of radical prostatectomy for cancer treatment at least 6 months prior to enrollment
干预措施: Axonics SNM System (Device)
Benign Prostatic Hyperplasia (BPH)
History of cytoreductive BPH surgery at least 6 months prior to enrollment
干预措施: Axonics SNM System (Device)
结局指标
主要结局
Adverse event reporting (Safety)
时间窗: 6 months, 1 year
Device related, procedure-related and all serious adverse events
Adverse event reporting (Safety)
时间窗: 6 months, 1 year
Device related, procedure-related and all serious adverse events
Performance/Effectiveness - Reduction in UUI or UF episodes
时间窗: 6 months, 1 year
Demonstrate a ≥ 50% reduction in the number of UUI or UF episodes on a 3-day diary
次要结局
- Performance/Effectiveness - Improvement in Quality of Life scoring(6 months, 1 year)