Spinal Cord InjuriesNCT04231474
Urodynamic Evaluation in Patients After Spinal Cord Injury
An observational study of Spinal Cord Injuries and Neurogenic Bladder, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Retrospective study, which analyzed 100 medical histories of patients who were admitted o the Neurological Rehabilitation Ward of the Rehabilitation Clinic in the Orthopedic-Rehabilitation Hospital in Poznan in years 2010-2019. Read more about this study
- Who is it for?
- Ages 30 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Neurogenic Bladder, Urodynamics
- What is being tested?
- Urodynamic testing
- Type of treatment
- Medical device
- How many people
- 2 participants
- Where
- 1 sitePoland
- Study dates
- 20 Jan 2020to 1 Mar 2020
- 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 30 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Eventually, 54 patients were enrolled in the study (12 women, 42 men). The incompleteness and level of SCI were diagnosed based on MRI, which was performed directly after the injury in Neurosurgery Ward or Trauma Center.
Who may be able to join
- incomplete spinal cord injuries,
- the results of the urodynamic testing (conducted by the same urologist) by admission,
- urine culture test by admission.
Who cannot join
- complete spinal cord injury
- without urodynamic test in medical documentation by admission,
- without urine culture test by admission,
- with symptomatic urinary tract infection in urodynamic test
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Rehabilitation and Physiotherapy Rehabilitation,
Poznan, 61-545
Ewa Chlebuś, lek, 600195386, ewachlebus@ump.edu.pl
About this study
Official title: Urodynamic Evaluation Neurgenic Bladder in Patients After Spinal Cord Injury
Retrospective study, which analyzed 100 medical histories of patients who were admitted o the Neurological Rehabilitation Ward of the Rehabilitation Clinic in the Orthopedic-Rehabilitation Hospital in Poznan in years 2010-2019.
Read the detailed description
All patients considered for the study underwent routine testing: blood counts, urinalysis, urine culture, and sensitivity.
- Conditions
- Spinal Cord Injuries, Neurogenic Bladder, Urodynamics
- Being tested
- Urodynamic testing
- Keywords
- Urodynamics
- 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.
Urodynamic testingDevice
All data were obtained using the MMS Alfa 4T by the same urologist with use of an 8 Charr catheter.
| Study group | Role | What they receive |
|---|---|---|
| Demographic and clinical features of the patients | Number of patients Time from injury to hospitalization Time from injury to urodynamic evaluation Duration of hospitalization Receives: Device: Urodynamic testing | |
| Comparison of urodynamic outcomes | Treatment options in patients with level SCI : cervical, thoracical and lumbar spinal cord injury Receives: Device: Urodynamic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urethra sensation
2 - preserved, 1- reduced, 0 - absent
Measured: 30 days after spinal injury,
Urethra sensation
2 - preserved, 1- reduced, 0 - absent
Measured: after 3 months of rehabilitation
Intravesical pressure
0- normal, 1- low
Measured: 30 days after spinal injury,
Intravesical pressure
0- normal, 1- low
Measured: after 3 months of rehabilitation
Bladder complaince
2- high, 1- reduced
Measured: 30 days after spinal injury,
Bladder complaince
2- high, 1- reduced
Measured: after 3 months of rehabilitation
Bladder stability
0 -stable, 1- hyperactive
Measured: 30 days after spinal injury,
Bladder stability
0 -stable, 1- hyperactive
Measured: after 3 months of rehabilitation
Bladder sensation
2-preserved,1- reduced, 0- absent
Measured: 30 days after spinal injury
Bladder sensation
2-preserved,1- reduced, 0- absent
Measured: after 3 months of rehabilitation
Bladder capacity
ml ( Average, Median, SD)
Measured: 30 days after spinal injury
Bladder capacity
ml ( Average, Median, SD)
Measured: after 3 months of rehabilitation
Urine volume
ml ( Average, Median,SD)
Measured: 30 days after spinal injury
Urine volume
ml ( Average, Median,SD)
Measured: after 3 months of rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start20 Jan 2020 (estimated)
- Primary completion31 Jan 2020 (estimated)
- Study completion1 Mar 2020 (estimated)
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
- Other
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ewa Chlebus, Poznan University of Medical Sciences
- Investigators
- Przemysław Lisiński, MPhD, Study director, Clinic Rehabilitation, University of Medical Sciences in Poznań
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231474
- Sponsor's protocol ID
- 1/2019CReh
- Other IDs
- 111/19
- Status last verified
- Jan 2020
- First submitted
- 25 Nov 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Urodynamic evaluation in patients after spinal cord injury
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urodynamic Evaluation Neurgenic Bladder in Patients After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04231474
- Acronym / sponsor ID
- 1/2019CReh
- Conditions
- Spinal Cord Injuries, Neurogenic Bladder, Urodynamics
- Keywords
- Urodynamics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 20 Jan 2020 (estimated)
- Primary completion
- 31 Jan 2020 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 18 Jan 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.
Retrospective study, which analyzed 100 medical histories of patients who were admitted o the Neurological Rehabilitation Ward of the Rehabilitation Clinic in the Orthopedic-Rehabilitation Hospital in Poznan in years 2010-2019.
Detailed description
All patients considered for the study underwent routine testing: blood counts, urinalysis, urine culture, and sensitivity.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Demographic and clinical features of the patients | – | Device: Urodynamic testingNumber of patients Time from injury to hospitalization Time from injury to urodynamic evaluation Duration of hospitalization |
| Comparison of urodynamic outcomes | – | Device: Urodynamic testingTreatment options in patients with level SCI : cervical, thoracical and lumbar spinal cord injury |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Eventually, 54 patients were enrolled in the study (12 women, 42 men). The incompleteness and level of SCI were diagnosed based on MRI, which was performed directly after the injury in Neurosurgery Ward or Trauma Center.
Key inclusion criteria (3 listed)
- incomplete spinal cord injuries,
- the results of the urodynamic testing (conducted by the same urologist) by admission,
- urine culture test by admission.
Key exclusion criteria (4 listed)
- complete spinal cord injury
- without urodynamic test in medical documentation by admission,
- without urine culture test by admission,
- with symptomatic urinary tract infection in urodynamic test
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 |
|---|---|---|
| Urodynamic testingAll data were obtained using the MMS Alfa 4T by the same urologist with use of an 8 Charr catheter. | Device | Comparison of urodynamic outcomes, Demographic and clinical features of the patients |
Primary outcome
Urethra sensation
Time frame: 30 days after spinal injury,
2 - preserved, 1- reduced, 0 - absent
Urethra sensation
Time frame: after 3 months of rehabilitation
2 - preserved, 1- reduced, 0 - absent
Intravesical pressure
Time frame: 30 days after spinal injury,
0- normal, 1- low
Intravesical pressure
Time frame: after 3 months of rehabilitation
0- normal, 1- low
Bladder complaince
Time frame: 30 days after spinal injury,
2- high, 1- reduced
Bladder complaince
Time frame: after 3 months of rehabilitation
2- high, 1- reduced
Bladder stability
Time frame: 30 days after spinal injury,
0 -stable, 1- hyperactive
Bladder stability
Time frame: after 3 months of rehabilitation
0 -stable, 1- hyperactive
Bladder sensation
Time frame: 30 days after spinal injury
2-preserved,1- reduced, 0- absent
Bladder sensation
Time frame: after 3 months of rehabilitation
2-preserved,1- reduced, 0- absent
Bladder capacity
Time frame: 30 days after spinal injury
ml ( Average, Median, SD)
Bladder capacity
Time frame: after 3 months of rehabilitation
ml ( Average, Median, SD)
Urine volume
Time frame: 30 days after spinal injury
ml ( Average, Median,SD)
Urine volume
Time frame: after 3 months of rehabilitation
ml ( Average, Median,SD)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: Undecided. Urodynamic evaluation in patients after spinal cord injury
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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.
Przemysław Lisiński, MPhD study director
Clinic Rehabilitation, University of Medical Sciences in Poznań
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Neurogenic Bladder, run by Poznan University of Medical Sciences at 1 site in Poland.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ewa Chlebuś (600195386, ewachlebus@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urethra sensation (time frame: 30 days after spinal injury,). The study lists 14 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 18 Jan 2020.