Detrusor Activity Recovery in Acute Traumatic Spinal Cord Injuries

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

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

Study Overview

• Status: Withdrawn
• Conditions: Spinal Cord Injuries; Neurogenic Bladder; Spinal Shock
• Intervention / Treatment: Diagnostic test: Cystometrogram

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.

• Study Type: Observational

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Acute traumatic spinal cord injuries

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detrusor activity recovery	Pressure change (Detrusor pressure change in filling cystometrogram)	Every 3 days in spinal shock phase (up to 3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital
• Collaborators: Coloplast A/S
• Investigators: Principal Investigator: Sungchul Huh, PhD, Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: December 28, 2021
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Trauma, Nervous System; Urinary Bladder Diseases; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries; Urinary Bladder, Neurogenic
• Other Study ID Numbers: DRASS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No