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临床试验/NCT02677753
NCT02677753已完成不适用

InterStim Implantation Rates Following Percutaneous Nerve Evaluation With Fluoroscopy Versus Without

University of Louisville2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
2
主要终点
Number of Participants With InterStim Implantation Following PNE With or Without Use of Fluoroscopy

研究概览

简要总结

The investigators propose a randomized control trial comparing the rate of implantation of the InterStim device following Percutaneous Nerve Evaluation (PNE) performed with or without fluoroscopic guidance.

详细描述

Sacral nerve stimulation (SNS) is a well-established treatment for refractory urinary urgency, frequency, retention and urge incontinence as well as fecal incontinence. Patients whose symptoms are refractory to more conservative therapies such as behavioral modification and/or medications are candidates for SNS. The InterStim system consists of a permanent tined lead and implantable pulse generator (IPG) or battery that delivers the sacral neuromodulation. This device is typically implanted after patients have a successful response to a trial of sacral neuromodulation with a temporary lead and external battery. The temporary lead placement is known as a Percutaneous Nerve Evaluation (PNE) and is typically done in as an outpatient procedure using local anesthetic. It is standard practice to use fluoroscopy intraoperatively to confirm correct placement of the permanent lead. Additionally, some physicians also use fluoroscopy to confirm correct placement of temporary lead during PNE while others place the lead based on anatomical landmarks and expected elicited responses for S3 stimulation.

The investigators propose a randomized control trial comparing the rate of implantation of the InterStim device following (PNE) performed with or without fluoroscopic guidance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women age >18
  • English speakers
  • Patients with urinary urgency, frequency, or urge incontinence refractory to at least 1 other intervention who elect to undergo PNE

排除标准

  • Patients in whom bilateral leads cannot be placed
  • Pregnant women
  • Prisoners
  • Less than 18 years of age

结局指标

主要结局

Number of Participants With InterStim Implantation Following PNE With or Without Use of Fluoroscopy

时间窗: 3 months

Percentage of PNEs that have permanent neuromodulation device implanted by 3 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sean Francis

Principal investigator

University of Louisville

研究点 (2)

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