Autonomic dysreflexia and bladder filling speed in people with spinal cord injury.

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

Researchers will test whether different bladder filling speeds during urodynamic testing change how often or how severely autonomic dysreflexia happens in people with chronic spinal cord injury.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Sex: All
• Sponsor: Pusan National University Yangsan Hospital (Academic / other)
• Locations: 1 site (Yangsan, Gyeongsangnam-do)
• Trial ID: NCT06211491 on ClinicalTrials.gov

What this trial studies

This observational study will compare the prevalence and characteristics of autonomic dysreflexia (AD) during standardized urodynamic tests performed with different bladder filling (injection) speeds in people with chronic spinal cord injury. Eligible participants are at least six months post-injury with neurological levels C1–T6 and AIS A or B and a prior urodynamic test showing AD triggered by bladder fullness; investigators will record blood pressure responses and bladder pressures during testing. The analysis will determine whether filling speed or bladder expansion (and patient factors such as age and maximum detrusor pressure) more strongly predicts AD frequency and severity. For safety, patients with persistent systolic blood pressure ≥150 mmHg during testing, hemodynamic instability, or active urinary tract infection will be excluded.

Who should consider this trial

Good fit: People with chronic spinal cord injury (≥6 months) at neurological level C1–T6 with AIS A or B who previously had autonomic dysreflexia triggered by bladder filling and can safely undergo urodynamic testing.

Not a fit: Patients with active urinary tract infection, hemodynamic instability, or persistent high systolic blood pressure during testing (or those with different injury levels/less severe impairment) are unlikely to benefit from the study findings.

Why it matters

Potential benefit: If successful, the findings could help make urodynamic testing safer by identifying filling rates or conditions that reduce the risk or severity of AD for people with spinal cord injury.

How similar studies have performed: Previous reports suggest urethral or sphincter stimulation, age, and maximum bladder pressure may influence AD more than filling speed, so while related observations exist this study addresses a largely unquantified effect of filling rate.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Where this trial is running

Yangsan, Gyeongsangnam-do

• Pusan National University Yangsan Hospital — Yangsan, Gyeongsangnam-do, South Korea (Recruiting)

Study contacts

• Principal investigator: Sungchul Huh, Ph.D — Pusan National University Yangsan Hospital
• Study coordinator: Sungchul Huh, Ph.D

Conditions Spinal Cord Injuries; Autonomic Dysreflexia; UDS Filling Speed