Detrusor Activity Recovery in Acute Traumatic Spinal Cord Injuries

Brief Title

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

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.
    


Study Type

Observational [Patient Registry]


Primary Outcome

Detrusor activity recovery

Secondary Outcome

 Reflexes

Condition

Spinal Cord Injuries

Intervention

Cystometrogram


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

30

Start Date

March 1, 2022

Completion Date

December 31, 2023

Primary Completion Date

December 31, 2023

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
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

, +82-10-9354-2177, [email protected]



Administrative Informations


NCT ID

NCT05207826

Organization ID

DRASS


Responsible Party

Principal Investigator

Study Sponsor

Pusan National University Yangsan Hospital

Collaborators

 Coloplast A/S

Study Sponsor

, , 


Verification Date

January 2022