Autonomic Dysreflexia in Spinal Cord Injuries: UDS Filling Speed Impact

NCT06211491 | Recruiting

• 1 other identifier: UDS filling speed
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Autonomic Dysreflexia; UDS Filling Speed

Outcome Measures

Primary Outcomes (1)

• Bladder volume (ml)

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

  Immediately after the test

Secondary Outcomes (4)

• 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

Interventions

Urodynamic test OTHER

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic spinal cord injuries

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Autonomic Dysreflexia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Autonomic Nervous System Diseases

Study Officials

• Sungchul Huh, Ph.D

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sungchul Huh, Ph.D

CONTACT

055-360-4000; dr.huhsc@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 18, 2024
• Study Start: January 8, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)