Somatosensory Evoked Potentials From the Lower Urinary Tract in Individuals With Neurogenic Lower Urinary Tract Dysfunction as a Result of Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- occurrence of somatosensory evoked potentials from the bladder
研究概览
简要总结
Spinal cord injury and other systemic neurological diseases (Multiple Sclerosis, Parkinson's disease) affect the integrity of lower urinary tract (LUT) function, leading to neurogenic lower urinary tract dysfunction (NLUTD). The urodynamic investigation is the current "gold-standard" for evaluating LUT function. Nevertheless, the sensory situation of the LUT cannot be investigated objectively. Furthermore, the current classification of the severity of the NLUTD due to spinal cord injury (SCI) does not represent the sensory situation of the LUT. Additional investigations therefore need to be established for assessing the sensory situation of the LUT. Somatosensory evoked potentials (SEPs) are an established method for investigating the processing of sensory nervous activity. However, SEPs from the LUT of SCI individuals have not yet been investigated.
A novel technique, i.e. diffusion tensor imaging (DTI), allows to process magnetic resonance images (MRI) in order to visualize nerve fibers. Using DTI, the innervation of the bladder after SCI can be visualized. The structural presentation of bladder innervation will be compared with the functional results, i.e. the SEP of the LUT in SCI individuals.
The primary objective of the proposed study is to elicit and characterize (latency, amplitude) the somatosensory evoked potentials (SEPs) from the bladder in individuals suffering from neurogenic lower urinary tract dysfunction as a result of spinal cord injury.
Furthermore, the SEPs from the bladder will be compared with the SEPs from peripheral nerves (N. tibialis, N. pudendus, N. medianus).
Moreover, the latency and amplitude of the SEPs from the bladder of individuals with somato-sensory complete spinal cord injury will be compared with those from the bladder of individuals with somato-sensory incomplete spinal cord injury.
Finally, the structural innervation of the bladder after SCI will be compared with the remaining sensory function.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent as documented by signature
- •Chronic SCI of a minimum of 1 year
- •Aetiology of SCI: traumatic
排除标准
- •Age < 18 years or > 70 years
- •Aetiology of SCI: non-traumatic
- •History of bleeding disorder
- •History of chronic neuropathic pain
- •Intravesical botulinum toxin injections < 12 months ago
- •Bladder management using indwelling catheters (suprapubic, transurethral)
- •Bladder augmentation
- •Sacral deafferentation
- •Sacral neuromodulation
- •Acute, symptomatic urinary tract infection
- •Pregnancy
- •Urolithiasis
- •Bladder cancer
- •Exclusion criteria for MRI (cardiac pace maker, implanted metal etc.)
结局指标
主要结局
occurrence of somatosensory evoked potentials from the bladder
时间窗: within 1 week after enrollment into study
次要结局
- peak-to-peak amplitude of somatosensory evoked potentials(within 1 week after enrollment into study)
- nerve fiber density around bladder(within 1 week after enrollment into study)
- fractional anisotropy of nerve fibers around bladder(within 1 week after enrollment into study)
- latency of somatosensory evoked potentials(within 1 week after enrollment into study)
- apparent diffusion coefficient of nerve fibers around bladder(within 1 week after enrollment into study)