Status:
WITHDRAWN
Detrusor Activity Recovery in Acute Traumatic Spinal Cord Injuries
Lead Sponsor:
Pusan National University Yangsan Hospital
Collaborating Sponsors:
Coloplast A/S
Conditions:
Spinal Cord Injuries
Neurogenic Bladder
Eligibility:
All Genders
18-75 years
Brief Summary
Determining the most appropriate time to evaluate detrusor activity in urodynamic studies for both traumatic and non-traumatic spinal cord injuries
Detailed Description
The detrusor activity in the acute phase of the spinal cord injury changes with the development of the spinal shock. Spinal shock is a phase of areflexic phase after the spinal cord injury that is pri...
Eligibility Criteria
Inclusion
- Acute onset suprasacral spinal cord injury with both traumatic and non-traumatic causes within the first 15 days after spinal cord injury(very acute phase of SCI according to European Multicenter Study about SCI : the first 15 d (very acute), between 16-40 d (acute I), and 3 mo (acute II), 6 mo (acute III), and 12 mo (chronic) after SCI)
- Age older than 18
- Inpatient
- Patients with spinal cord injuries who initially keep the indwelling catheter
- Patients with or without spinal shock
Exclusion
- nstable vital sign (using Inotropics or vasopressors or antiarrhythmic agents)
- Current urinary tract infection
- Agitated behavior (Richmond Agitation and Sedation Scale of +2 to +4)
- Decreased mentality (RASS of -2 to -5)
- Concomitant sacral lesions (Ex. Sacral fracture, pelvic bone fracture, urologic trauma)
- Concomitant supraspinal lesions (Ex. Traumatic brain injury, old stroke, Parkinson disease)
- Uncontrolled DM
- Medical history of lower urinary tract dysfunction (Ex. BPH, Malignancy)
- Uncontrlled autonomic dysreflexia (In case of autonomic dysreflexia, defined according to ISAFSCI (International Standards to document remaining Autonomic Function after SCI) as an increase in systolic blood pressure 20 mm Hg or greater from baseline
Key Trial Info
Start Date :
March 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05207826
Start Date
March 1 2022
End Date
December 31 2023
Last Update
June 22 2025
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