Detrusor Activity Recovery in Acute Traumatic Spinal Cord Injuries

NCT05207826 | Withdrawn

• 1 other identifier: DRASS
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Spinal Cord Injuries; Neurogenic Bladder; Spinal Shock

Outcome Measures

Primary Outcomes (1)

• Detrusor activity recovery

  Pressure change (Detrusor pressure change in filling cystometrogram)

  Every 3 days in spinal shock phase (up to 3 months)

Secondary Outcomes (1)

• Reflexes

  Every 3 days in spinal shock phase (up to 3 months)

Interventions

Cystometrogram DIAGNOSTIC_TEST

Serial cystometrogram every 3 days for acute traumatic spinal cord injured patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute traumatic spinal cord injuries

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead
• Coloplast A/S: collaborator

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sungchul Huh, PhD

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: January 26, 2022
• Study Start: March 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share