Autonomic Dysreflexia in Spinal Cord Injuries: UDS Fillin... | NCT06211491

Studies
Autonomic Dysreflexia in Spinal Cord Injuries: UDS Filling Speed Impact

NCT06211491

Sponsor

Pusan National University Yangsan Hospital

Status

Recruiting

Last Update Posted

Jan 14, 2026Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Spinal Cord Injuries
Autonomic Dysreflexia
UDS Filling Speed

Interventions

Urodynamic test

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 8, 2025Actual

Primary Completion Date

Aug 30, 2026Estimated

Completion Date

Dec 30, 2026Estimated

First Submitted Date

Dec 21, 2023

First Submission Date that Met QC Criteria

Jan 8, 2024

First Posted Date

Jan 18, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2026

Last Update Posted Date

Jan 14, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sungchul Huh, Assistant Professor, Pusan National University Yangsan HospitalPrincipal Investigator

Lead Sponsor

Pusan National University Yangsan HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Bladder compliance (mL/cmH2O)	Bladder compliance	Immediately after the test
Symptoms (Y/N)	Symptoms	Immediately after the test

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Chronic spinal cord injuries

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sungchul Huh, Ph.D	Contact	055-360-4000		dr.huhsc@gmail.com

Overall Officials

Name	Affiliation	Role
Sungchul Huh, Ph.D	Pusan National University Yangsan Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pusan National University Yangsan Hospital	Recruiting	Yangsan	Gyeongsangnam-do	50612	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries
D020211	Autonomic Dysreflexia

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

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Browse Branches

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