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临床试验/NCT02138149
NCT02138149已完成不适用

Is the Nerve Growth Factor (NGF) a Useful Biomarker in Neurogenic Bladder Dysfunction After Spinal Cord Injury?

Swiss Paraplegic Research, Nottwil1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
47
试验地点
1
主要终点
urinary concentration of nerve growth factor

研究概览

简要总结

Spinal cord injury (SCI) almost always affects bladder function as well. As a result of this bladder dysfunction, individuals with SCI have to undergo regular invasive examination of their bladder function (urodynamic examination).

The nerve growth factor (NGF) is released from smooth muscle cells of the bladder, and there are reports, that the concentration of NGF is elevated in the urine of patients with bladder dysfunction. The NGF concentration can also be measured in the blood. The concentration of NGF in the blood and urine of SCI individuals has not yet been investigated. These concentrations may correlate with the severity of bladder dysfunction, and may thus be used to replace or at least reduce the number of the more invasive urodynamic examinations.

The hypothesis that urine and blood NGF concentrations in individuals with SCI are higher compared to individuals with healthy bladder function will be tested.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • physiologic bladder function

排除标准

  • no signed consent form
  • age <18 / >80 years
  • urinary tract infection
  • bladder surgery
  • radiation therapy of the pelvic area
  • pregnancy
  • bleeding disorder
  • Study Group
  • Inclusion Criteria:
  • neurogenic detrusor overactivity
  • presentation for urodynamic examination
  • Exclusion Criteria:
  • no signed consent form
  • age <18 / >80 years
  • urinary tract infection
  • bladder augmentation
  • bladder evacuation by permanent catheterization
  • radiation therapy of the pelvic area
  • pregnancy
  • bleeding disorder

结局指标

主要结局

urinary concentration of nerve growth factor

时间窗: day 0

次要结局

  • urodynamics(day 0)
  • demographics(day 0)
  • serum concentration of nerve growth factor(day 0)
  • International Prostate Symptom Score (I-PSS)(day 0)

研究者

发起方
Swiss Paraplegic Research, Nottwil
申办方类型
Network
责任方
Sponsor

研究点 (1)

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