Spinal Cord InjuriesNCT06211491
Autonomic Dysreflexia in Spinal Cord Injuries: UDS Filling Speed Impact
An observational study of Spinal Cord Injuries and Autonomic Dysreflexia, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Cord Injuries, Autonomic Dysreflexia, UDS Filling Speed
- What is being tested?
- Urodynamic test
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Jan 2025to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chronic spinal cord injuries
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612
Sungchul Huh, MD, +82-10-9354-2177, dr.huhsc@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Urodynamic test
- Medical subject headings
- Spinal Cord Injuries, Autonomic Dysreflexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urodynamic testOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after the test
Secondary outcomes (4)
Bladder compliance (mL/cmH2O)
Bladder compliance
Measured: Immediately after the test
Symptoms (Y/N)
Symptoms
Measured: Immediately after the test
Blood pressure (mmHg)
Blood pressure
Measured: Immediately after the test
Heart rate (bpm)
Heart rate
Measured: Immediately after the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start8 Jan 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sungchul Huh, Pusan National University Yangsan Hospital
- Investigators
- Sungchul Huh, Ph.D, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211491
- Sponsor's protocol ID
- UDS filling speed
- Status last verified
- Jan 2026
- First submitted
- 21 Dec 2023
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Dysreflexia Clinical Characteristics According to the Filling Speed in Urodynamics in Individuals With Spinal Cord Injuries
- ClinicalTrials.gov ID
- NCT06211491
- Acronym / sponsor ID
- UDS filling speed
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chronic spinal cord injuries
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urodynamic testUrodynamic 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. | Other | – |
Primary outcome
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
4 secondary outcomes
Bladder compliance (mL/cmH2O)
Time frame: Immediately after the test
Symptoms (Y/N)
Time frame: Immediately after the test
Blood pressure (mmHg)
Time frame: Immediately after the test
Heart rate (bpm)
Time frame: Immediately after the test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sungchul Huh, Ph.D principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Autonomic Dysreflexia, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sungchul Huh, Ph.D (055-360-4000, dr.huhsc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder volume (ml) (time frame: Immediately after the test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.