Spinal Cord InjuriesNCT04642170
Urodynamics of Suprasacral Spinal Cord Injury Patients
An observational study of Spinal Cord Injuries, run by Second Affiliated Hospital of Wenzhou Medical University.
Trial summary
The medical records of 215 patients with spinal cord injury(SCI) at the Department of Rehabilitation Medicine of the 2nd Affiliated Hospital of Wenzhou Medical University, Wenzhou, China were evaluated between January 1, 2016 and December 20, 2019. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Cord Injuries
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 20 Dec 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Traumatic spinal cord injury patients with voiding dysfunction and had urodynamic examination.
Who may be able to join
- the period of the spinal shock has passed.
- patients diagnosed with traumatic suprasacral SCI, based on AIS.
- urodynamic investigations were performed by the same urologist.
- patients with voiding dysfunction.
Who cannot join
- The patient with voiding dysfunction before the injury were excluded.
About this study
Official title: Urodynamic Findings in Patients With Complete and Incomplete Suprasacral Spinal Cord Injury at Different Stages After Injury
The medical records of 215 patients with spinal cord injury(SCI) at the Department of Rehabilitation Medicine of the 2nd Affiliated Hospital of Wenzhou Medical University, Wenzhou, China were evaluated between January 1, 2016 and December 20, 2019. According to the inclusion criteria and exclusion criteria, 101 patients were included. The patients were dichotomized into two groups: complete SCI group and incomplete SCI group, based on the American Spinal Injury Association Guidelines Impairment Scale (AIS) .The investigators retrospectively collected records of urodynamic evaluations of this patients and then analyze the urodynamic parameters,including detrusor overactivity (DO), bladder compliance (BC), bladder-filling sensation, maximum cystometric capacity (MCC), detrusor external sphincter dyssynergia (DESD), maximum urinary flow rate (Qmax), detrusor pressure at a maximum urinary flow rate(PdetQmax).
- Conditions
- Spinal Cord Injuries
- Medical subject headings
- Spinal Cord Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
detrusor overactivity (DO)
detrusor overactivity in milliliter,one of the urodynamic parameters
Measured: 0-365 days after injury
bladder compliance (BC)
bladder compliance in ml/cmH2O,one of the urodynamic parameters
Measured: 0-365 days after injury
bladder-filling sensation
bladder-filling sensation,one of the urodynamic parameters
Measured: 0-365 days after injury
Secondary outcomes (2)
maximum cystometric capacity (MCC)
maximum cystometric capacity in milliliter,one of the urodynamic parameters
Measured: 0-365 days after injury
detrusor external sphincter dyssynergia (DESD)
detrusor external sphincter dyssynergia,one of the urodynamic parameters
Measured: 0-365 days after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start1 Jan 2016
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
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.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junyan Lu, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642170
- Sponsor's protocol ID
- SAHoWMU-CR2020-15-212
- Status last verified
- Nov 2020
- First submitted
- 14 Nov 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urodynamic Findings in Patients With Complete and Incomplete Suprasacral Spinal Cord Injury at Different Stages After Injury
- ClinicalTrials.gov ID
- NCT04642170
- Acronym / sponsor ID
- SAHoWMU-CR2020-15-212
- Conditions
- Spinal Cord Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 24 Nov 2020 (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.
The medical records of 215 patients with spinal cord injury(SCI) at the Department of Rehabilitation Medicine of the 2nd Affiliated Hospital of Wenzhou Medical University, Wenzhou, China were evaluated between January 1, 2016 and December 20, 2019. According to the inclusion criteria and exclusion criteria, 101 patients were included. The patients were dichotomized into two groups: complete SCI group and incomplete SCI group, based on the American Spinal Injury Association Guidelines Impairment Scale (AIS) .The investigators retrospectively collected records of urodynamic evaluations of this patients and then analyze the urodynamic parameters,including detrusor overactivity (DO), bladder compliance (BC), bladder-filling sensation, maximum cystometric capacity (MCC), detrusor external sphincter dyssynergia (DESD), maximum urinary flow rate (Qmax), detrusor pressure at a maximum urinary flow rate(PdetQmax).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Traumatic spinal cord injury patients with voiding dysfunction and had urodynamic examination.
Key inclusion criteria (4 listed)
- the period of the spinal shock has passed.
- patients diagnosed with traumatic suprasacral SCI, based on AIS.
- urodynamic investigations were performed by the same urologist.
- patients with voiding dysfunction.
Key exclusion criteria (1 listed)
- The patient with voiding dysfunction before the injury were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
detrusor overactivity (DO)
Time frame: 0-365 days after injury
detrusor overactivity in milliliter,one of the urodynamic parameters
bladder compliance (BC)
Time frame: 0-365 days after injury
bladder compliance in ml/cmH2O,one of the urodynamic parameters
bladder-filling sensation
Time frame: 0-365 days after injury
bladder-filling sensation,one of the urodynamic parameters
2 secondary outcomes
maximum cystometric capacity (MCC)
Time frame: 0-365 days after injury
detrusor external sphincter dyssynergia (DESD)
Time frame: 0-365 days after injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by Second Affiliated Hospital of Wenzhou Medical University.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 24 Nov 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 overactivity (DO) (time frame: 0-365 days after injury). The study lists 3 primary outcomes in all. 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 24 Nov 2020; AzTrials last refreshed its copy on 7 Nov 2026.