Spinal Cord InjuriesNCT05207826
Detrusor Activity Recovery in Acute Traumatic Spinal Cord Injuries
An observational study of Spinal Cord Injuries and Neurogenic Bladder, run by Pusan National University Yangsan Hospital.
Trial summary
Determining the most appropriate time to evaluate detrusor activity in urodynamic studies for both traumatic and non-traumatic spinal cord injuries Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries, Neurogenic Bladder, Spinal Shock
- What is being tested?
- Cystometrogram
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 31 Dec 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute traumatic spinal cord injuries
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
About this study
Official title: 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
Read the 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.
- Conditions
- Spinal Cord Injuries, Neurogenic Bladder, Spinal Shock
- Being tested
- Cystometrogram
- Medical subject headings
- Spinal Cord Injuries, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CystometrogramDiagnostic test
Serial cystometrogram every 3 days for acute traumatic spinal cord injured patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Detrusor activity recovery
Pressure change (Detrusor pressure change in filling cystometrogram)
Measured: Every 3 days in spinal shock phase (up to 3 months)
Secondary outcomes (1)
Reflexes
Superficial reflex and pathologic reflex (Cremasteric reflex, Dartos reflex, BC reflex, anal reflex, Babinski reflex, delayed plantar reflex)
Measured: Every 3 days in spinal shock phase (up to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Mar 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Why it stopped: Cancelled to conduct study on similar but more appropriate topics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Coloplast A/S
- Responsible party
- Principal investigator, Sungchul Huh, Pusan National University Yangsan Hospital
- Investigators
- Sungchul Huh, PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207826
- Sponsor's protocol ID
- DRASS
- Status last verified
- Jun 2025
- First submitted
- 28 Dec 2021
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Most Appropriate Time to Evaluate Detrusor Activity Recovery in Acute Traumatic Spinal Cord Injuries
- ClinicalTrials.gov ID
- NCT05207826
- Acronym / sponsor ID
- DRASS
- Conditions
- Spinal Cord Injuries, Neurogenic Bladder, Spinal Shock
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Cancelled to conduct study on similar but more appropriate topics
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Collaborators
- Coloplast A/S
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute traumatic spinal cord injuries
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CystometrogramSerial cystometrogram every 3 days for acute traumatic spinal cord injured patients | Diagnostic test | – |
Primary outcome
Detrusor activity recovery
Time frame: Every 3 days in spinal shock phase (up to 3 months)
Pressure change (Detrusor pressure change in filling cystometrogram)
1 secondary outcome
Reflexes
Time frame: Every 3 days in spinal shock phase (up to 3 months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sungchul Huh, PhD principal investigator
Pusan National University Yangsan Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Neurogenic Bladder, run by Pusan National University Yangsan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detrusor activity recovery (time frame: Every 3 days in spinal shock phase (up to 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.