Autonomic Dysreflexia in Spinal Cord Injuries: UDS Filling Speed Impact

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06211491
• Other study ID #: UDS filling speed
• Status: Not yet recruiting
• Start date: May 30, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Pusan National University Yangsan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Autonomic Dysreflexia
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Immediately after the test
Secondary	Bladder compliance (mL/cmH2O)		Immediately after the test
Secondary	Symptoms (Y/N)		Immediately after the test
Secondary	Blood pressure (mmHg)		Immediately after the test
Secondary	Heart rate (bpm)		Immediately after the test