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临床试验/NCT05207826
NCT05207826撤回不适用

Determining the Most Appropriate Time to Evaluate Detrusor Activity Recovery in Acute Traumatic Spinal Cord Injuries

Pusan National University Yangsan Hospital0 个研究点开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Detrusor activity recovery

研究概览

简要总结

Determining the most appropriate time to evaluate detrusor activity in urodynamic studies for both traumatic and non-traumatic spinal cord injuries

详细描述

The detrusor activity in the acute phase of the spinal cord injury changes with the development of the spinal shock. Spinal shock is a phase of areflexic phase after the spinal cord injury that is primarily influenced by the severity of the injury and the neurological level of injury. Detrusor activity shows areflexic in the spinal shock phase, followed by a return of detrusor activity at the end of the spinal shock.

There was no recent study to provide evidence of an appropriate time to assess detrusor muscle activity through urodynamic studies. There were only a few limited studies on detrusor activity following spinal cord injury from 1960 to 1970. However, when the urodynamic study should be performed is still controversial.

Knowing the patterns of detrusor activity following spinal cord injuries is critical to determining the appropriate timing for intermittent catheterization, which is the standard emptying method of choice. If clinicians fail to understand true detrusor activity as early as possible, the patient will suffer from unnecessary indwelling catheter voiding, resulting in impaired quality of life in the acute phase.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acute onset suprasacral spinal cord injury with both traumatic and non-traumatic causes within the first 15 days after spinal cord injury(very acute phase of SCI according to European Multicenter Study about SCI : the first 15 d (very acute), between 16-40 d (acute I), and 3 mo (acute II), 6 mo (acute III), and 12 mo (chronic) after SCI)
  • Age older than 18
  • Inpatient
  • Patients with spinal cord injuries who initially keep the indwelling catheter
  • Patients with or without spinal shock

排除标准

  • nstable vital sign (using Inotropics or vasopressors or antiarrhythmic agents)
  • Current urinary tract infection
  • Agitated behavior (Richmond Agitation and Sedation Scale of +2 to +4)
  • Decreased mentality (RASS of -2 to -5)
  • Concomitant sacral lesions (Ex. Sacral fracture, pelvic bone fracture, urologic trauma)
  • Concomitant supraspinal lesions (Ex. Traumatic brain injury, old stroke, Parkinson disease)
  • Uncontrolled DM
  • Medical history of lower urinary tract dysfunction (Ex. BPH, Malignancy)
  • Uncontrlled autonomic dysreflexia (In case of autonomic dysreflexia, defined according to ISAFSCI (International Standards to document remaining Autonomic Function after SCI) as an increase in systolic blood pressure 20 mm Hg or greater from baseline

结局指标

主要结局

Detrusor activity recovery

时间窗: Every 3 days in spinal shock phase (up to 3 months)

Pressure change (Detrusor pressure change in filling cystometrogram)

次要结局

  • Reflexes(Every 3 days in spinal shock phase (up to 3 months))

研究者

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

Sungchul Huh

Assistant professor

Pusan National University Yangsan Hospital

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