Autonomic Dysreflexia in Spinal Cord Injuries: UDS Filling Speed Impact

January 12, 2026 updated by: Sungchul Huh, Pusan National University Yangsan Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
    • Gyeongsangnam-do
      • Yangsan, Gyeongsangnam-do, South Korea, 50612
        • Recruiting
        • Pusan National University Yangsan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Chronic spinal cord injuries

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bladder volume (ml)
Time Frame: 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
Immediately after the test

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bladder compliance (mL/cmH2O)
Time Frame: Immediately after the test
Bladder compliance
Immediately after the test
Symptoms (Y/N)
Time Frame: Immediately after the test
Symptoms
Immediately after the test
Blood pressure (mmHg)
Time Frame: Immediately after the test
Blood pressure
Immediately after the test
Heart rate (bpm)
Time Frame: Immediately after the test
Heart rate
Immediately after the test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Yangsan Hospital

Investigators

  • Principal Investigator: Sungchul Huh, Ph.D, Pusan National University Yangsan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2025

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

December 21, 2023

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Actual)

January 18, 2024

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDS filling speed

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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