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RecruitingNCT06211491Updated Jan 14, 2026

Autonomic Dysreflexia in Spinal Cord Injuries: UDS Filling Speed Impact

An observational study in Spinal Cord Injuries, Autonomic Dysreflexia and UDS Filling Speed, sponsored by Pusan National University Yangsan Hospital. Recruiting at 1 site in South Korea. Per ClinicalTrials.gov, last updated 2026-01-14.

Sponsored by Pusan National University Yangsan Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Sex
All
01

Study 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 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.

02

Conditions studied

  • Spinal Cord Injuries
  • Autonomic Dysreflexia
  • UDS Filling Speed
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Chronic spinal cord injuries

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

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
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Interventions

  • OtherUrodynamic 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.

05

What researchers measure

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

    Time frame: Immediately after the test

Secondary outcomes

  1. Bladder compliance (mL/cmH2O)

    Bladder compliance

    Time frame: Immediately after the test

  2. Symptoms (Y/N)

    Symptoms

    Time frame: Immediately after the test

  3. Blood pressure (mmHg)

    Blood pressure

    Time frame: Immediately after the test

  4. Heart rate (bpm)

    Heart rate

    Time frame: Immediately after the test

06

Study locations

1 of 1 sites recruiting
  • Pusan National University Yangsan Hospital
    Yangsan, Gyeongsangnam-do 50612, South Korea
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06211491
Lead sponsor
Pusan National University Yangsan Hospital
Responsible party
Sungchul Huh (Assistant Professor, Pusan National University Yangsan Hospital) — Principal investigator
First posted
Jan 18, 2024
Start date
Jan 8, 2025
Primary completion
Aug 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Jan 14, 2026

Study contacts

Sungchul Huh, Ph.D
Contact
dr.huhsc@gmail.com
055-360-4000
Sungchul Huh, Ph.D
principal investigator · Pusan National University Yangsan Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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