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Recruiting NCT06211491

Autonomic Dysreflexia in Spinal Cord Injuries: UDS Filling Speed Impact

Observational Spinal Cord Injuries Autonomic Dysreflexia UDS Filling Speed

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Urodynamic test.
Who it may be relevant to
Registry conditions: Spinal Cord Injuries, Autonomic Dysreflexia, UDS Filling Speed. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other Urodynamic test
    Urodynamic testing is performed using saline solution at the same temperature as body temperature (37 degrees) at two injection speeds of 10 mL/min and 100 mL/min, respectively.

Primary outcome measures

  • Bladder volume (ml) [Time frame: Immediately after the test]
Secondary outcome measures (4)
  • Bladder compliance (mL/cmH2O) [Time frame: Immediately after the test]
  • Symptoms (Y/N) [Time frame: Immediately after the test]
  • Blood pressure (mmHg) [Time frame: Immediately after the test]
  • Heart rate (bpm) [Time frame: Immediately after the test]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

South Korea · 1 center
  • Pusan National University Yangsan Hospital — Yangsan

Identifiers

NCT: NCT06211491 · UDS filling speed

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗