Autonomic Dysreflexia in Spinal Cord Injuries: UDS Filling Speed Impact

Recruiting

• Conditions: Spinal Cord Injuries; Autonomic Dysreflexia; UDS Filling Speed

• Registration Number: NCT06211491
• Lead Sponsor: Pusan National University Yangsan Hospital

Brief Summary

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.

Study Timeline

• Study First Submitted: 2023-12-21
• Study First Submitted QC: 2024-01-08
• Study First Posted: 2024-01-18
• Study Start: 2025-01-08
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-20
• Last Update Posted: 2025-06-25
• Primary Completion: 2025-08-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bladder volume (ml)	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Gyeongnam, Korea, Republic of