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临床试验/NCT03614754
NCT03614754Unknown不适用

The Involvement of Pudendal Somatic Afferents in Sacral Neuromodulation Assessed by Somatosensory Evoked Potentials of the Pudendal Nerve

Universiteit Antwerpen1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Latency change

研究概览

简要总结

Sacral neuromodulation is a well-excepted minimally invasive procedure for the treatment of overactive bladder and non-obstructive urinary retention.A tined lead with 4 stimulation electrodes is placed through the third or fourth sacral foramen and stimulates sacral roots in its vicinity. Since the sacral roots are mixed nerves, it is currently still unknown which nerve fibers are stimulated (autonomic vs somatic, afferent vs efferent) and what the mechanism of action is.

This study examines the involvement of pudendal somatic afferents by measuring somatosensory evoked potentials elicited by stimulation of the pudendal nerve.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Overactive bladder
  • Non-obstructive urinary retention

排除标准

  • Neurogenic disorders (e.g. cerebrovascular accident, spinal cord injury,...)

结局指标

主要结局

Latency change

时间窗: 3 weeks

Latency of somatosensory evoked potential are recorded before and after test procedure sacral neuromodulation expressed in milliseconds.

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

Donald Vaganée

MD, PhD student

Universiteit Antwerpen

研究点 (1)

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Sacral Neuromodulation and Pudendal Somatic Afferents | 临床试验