Clinical trial NCT05207826: Detrusor Activity Recovery in Acute Traumatic Spinal Cord Injuries
Official title: Determining the Most Appropriate Time to Evaluate Detrusor Activity Recovery in Acute Traumatic Spinal Cord Injuries
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Spinal Cord Injuries
Neurogenic Bladder
Spinal Shock
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
Collaborators: name: Coloplast A/S
First posted: 2022-01-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute traumatic spinal cord injuries

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 primarily influenced by the severity of the injury and the neurological level of injury. Detrusor activity shows areflexic in the spinal shock phase, followed by a return of detrusor activity at the end of the spinal shock.

There was no recent study to provide evidence of an appropriate time to assess detrusor muscle activity through urodynamic studies. There were only a few limited studies on detrusor activity following spinal cord injury from 1960 to 1970. However, when the urodynamic study should be performed is still controversial.

Knowing the patterns of detrusor activity following spinal cord injuries is critical to determining the appropriate timing for intermittent catheterization, which is the standard emptying method of choice. If clinicians fail to understand true detrusor activity as early as possible, the patient will suffer from unnecessary indwelling catheter voiding, resulting in impaired quality of life in the acute phase.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

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

Primary outcomes:
measure: Detrusor activity recovery
timeFrame: Every 3 days in spinal shock phase (up to 3 months)
Secondary outcomes:
measure: Reflexes
timeFrame: Every 3 days in spinal shock phase (up to 3 months)
Other outcomes:
Locations:
Study officials:
References: