InterStim Basic Evaluation Lead Post Market Clinical Follow-Up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 15
- 主要终点
- Motor or Sensory Response(s) During Lead Placement - by Subject
研究概览
简要总结
Post-market clinical follow-up for continued assessment of safety and performance of the InterStim basic evaluation lead and foramen needle(s) used during a therapy evaluation.
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
- •Subjects 18 years of age or older
- •Candidate for sacral neuromodulation in accordance with the InterStim System labeling
- •Have a diagnosis of overactive bladder (OAB) as demonstrated by either urinary urge incontinence and/or urinary frequency on a 3-day voiding diary
- •Willing and able to accurately complete study diaries, questionnaire, attend visits, and comply with the study protocol
- •Willing and able to provide signed and dated informed consent
排除标准
- •Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)
- •Have implantable pacemakers, or defibrillators
- •Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
- •Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or radio frequency (RF) energy exposure not included within the scanning conditions provided with the InterStim System labeling
- •Women who are pregnant or planning to become pregnant during participation in the study
- •Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements
- •Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.
研究组 & 干预措施
Basic evaluation
Subjects with overactive bladder will go through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit.
干预措施: InterStim Basic Evaluation lead and foramen needle (Device)
结局指标
主要结局
Motor or Sensory Response(s) During Lead Placement - by Subject
时间窗: During lead implant procedure (approximately 20 minutes)
To characterize the proportion of subjects who demonstrate motor or sensory response(s) during lead placement using the InterStim basic evaluation lead. A motor or sensory response was determined at the time of lead placement. Amplitude was titrated up from 0 until a response was reported and/or observed. A sensory response was defined as the lowest amplitude where the subject first perceived sensation of the stimulation. A motor response was defined as the lowest amplitude of electrical stimulation where a motor response (e.g. bellows response, anal wink and/or plantar flexion of the big toe) was observed.
次要结局
未报告次要终点