跳至主要内容
临床试验/NCT06211491
NCT06211491招募中不适用

Autonomic Dysreflexia Clinical Characteristics According to the Filling Speed in Urodynamics in Individuals With Spinal Cord Injuries

Pusan National University Yangsan Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Bladder volume (ml)

研究概览

简要总结

In patients with spinal cord injury, the investigators want to understand and understand the differences in AD prevalence and characteristics according to bladder injection rate, and to determine which factors have a greater influence between bladder expansion or injection rate.

详细描述

It has been reported that there is a difference in the degree of AD between the bladder and urinary tract motility tests, suggesting a potential difference according to the injection rate. According to Liu et al., the authors noted that stimulation of the urethra, prostate, and internal sphincter appears to induce AD more strongly than the injection rate. In addition, the two main factors contributing to AD among urinary kinetics tests are the patient's age and bladder maximum urination pressure. Considering these factors is important in preventing AD during urinary kinetics tests. Despite these previous studies, the prevalence and severity of AD according to the injection rate of urinary kinetics tests in SCI have not been quantitatively evaluated.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with chronic spinal cord injury 6 months after receiving the award
  • Patients with confirmed AD due to bladder fullness in previous urodynamic test
  • Patients confirmed to have neurological damage level C1-T6, AIS A or B

排除标准

  • Patients who cannot perform the test because their systolic blood pressure remains at 150 mmHg during the urodynamic test
  • Patients who cannot undergo testing due to hemodynamic instability
  • Patients who cannot undergo testing due to overt urinary tract infection

结局指标

主要结局

Bladder volume (ml)

时间窗: Immediately after the test

(1) at first AD at an infusion rate of 10 mL/min (2) at first AD at an infusion rate of 100 mL/min

次要结局

  • Bladder compliance (mL/cmH2O)(Immediately after the test)
  • Symptoms (Y/N)(Immediately after the test)
  • Blood pressure (mmHg)(Immediately after the test)
  • Heart rate (bpm)(Immediately after the test)

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

研究点 (1)

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