Autonomic Dysreflexia in Spinal Cord Injuries: UDS Filling Speed Impact

NCT ID: NCT06211491

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-08

Study Completion Date

2026-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Cord Injuries Autonomic Dysreflexia UDS Filling Speed

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pusan National University Yangsan Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sungchul Huh

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sungchul Huh, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Yangsan Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sungchul Huh, Ph.D

Role: CONTACT

055-360-4000

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sungchul Huh, MD

Role: primary

+82-10-9354-2177

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UDS filling speed

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Value of Urodynamic Evaluation
NCT00803959 COMPLETED PHASE4