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NCT Number: NCT06211491

Autonomic Dysreflexia in Spinal Cord Injuries: UDS Filling Speed Impact

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location status: Recruiting

Location contact

Sungchul Huh, MD

CONTACT

[email protected]

+82-10-9354-2177

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Bladder compliance (mL/cmH2O)

    Time frame: Immediately after the test

    Bladder compliance

  2. Symptoms (Y/N)

    Time frame: Immediately after the test

    Symptoms

  3. Blood pressure (mmHg)

    Time frame: Immediately after the test

    Blood pressure

  4. Heart rate (bpm)

    Time frame: Immediately after the test

    Heart rate

Study contacts

Contact information is provided by the study sponsor or research team.

Sungchul Huh, Ph.D

CONTACT

[email protected]

055-360-4000

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 18, 2024
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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