Detrusor Activity Recovery in Acute Traumatic Spinal Cord Injuries

Spinal Cord Injuries Clinical Trial

Official title:

Determining the Most Appropriate Time to Evaluate Detrusor Activity Recovery in Acute Traumatic Spinal Cord Injuries

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05207826
• Other study ID #: DRASS
• Status: Withdrawn
• Start date: March 1, 2022
• Est. completion date: December 31, 2023

Study information

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

Clinical Trial Summary

Determining the most appropriate time to evaluate detrusor activity in urodynamic studies for both traumatic and non-traumatic spinal cord injuries

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Neurogenic Bladder
• Spinal Cord Injuries
• Spinal Shock
• Urinary Bladder, Neurogenic
• Wounds and Injuries

Intervention

Diagnostic Test:
• Cystometrogram
Serial cystometrogram every 3 days for acute traumatic spinal cord injured patients

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital	Coloplast A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detrusor activity recovery	Pressure change (Detrusor pressure change in filling cystometrogram)	Every 3 days in spinal shock phase (up to 3 months)
Secondary	Reflexes	Superficial reflex and pathologic reflex (Cremasteric reflex, Dartos reflex, BC reflex, anal reflex, Babinski reflex, delayed plantar reflex)	Every 3 days in spinal shock phase (up to 3 months)