NCT00225966终止不适用
Patient Registry to Study the Tined Lead Used With the InterStim System For Urinary Control
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- Incidence of adverse events requiring surgical intervention
研究概览
简要总结
The purpose of this study is assess the long-term safety and effectiveness of the InterStim tined lead using a minimally invasive approach.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent
- •16 years of age or greater
- •Willing and able to complete voiding diaries and questionnaires at various time points during the study
- •Located geographically near the physician, or willing and able to travel to the physician's site as necessary for all required visits
- •Failed or is not a candidate for more conservative treatment
排除标准
- •Severe or uncontrolled diabetes; or diabetes with peripheral nerve involvement
- •Pregnancy or planned pregnancy
- •Concomitant medical conditions which would limit the success of the procedure such as: pelvic pain with uncertain etiology, active degenerative disc disease, spinal cord injury less than six months old, bleeding complications, or a cerebrovascular accident (CVA) less than six months old.
- •Anatomical limitations that would prevent successful placement of an electrode
- •Neurological diseases such as multiple sclerosis, clinically significant peripheral neuropathy or complete spinal cord injury (e.g., paraplegia)
- •Subject characteristics indicating a poor understanding of the study or poor compliance with the study protocol (e.g. subjects with psychological and/or emotional problems, subjects unable to adequately operate equipment)
- •Subjects with knowledge of planned magnetic resonance imaging (MRI), diathermy, microwave, high output ultrasonics, ultrasound scanning, or radiofrequency (RF) energy
- •Mechanical obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture
- •Symptomatic urinary tract infection (UTI). Upon completion of therapy for UTI, or if the subject is receiving prophylaxis for UTI, subjects can be considered for test stimulation or the full system implant (whichever is applicable) if symptom free for one month prior to the procedure.
- •Subjects with other implantable neurostimulators, pacemakers, or defibrillators
- •Primary stress incontinence or mixed incontinence where the stress component overrides the urge component
- •Active participation in another clinical study
结局指标
主要结局
Incidence of adverse events requiring surgical intervention
Incidence of lead migration
次要结局
- Incidence of infection
研究者
研究点 (2)
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