Spinal Cord InjuryNCT01299792
Sonographic Measurement of Bladder Wall Thickness in Patients With Neurogenic Bladder Dysfunction
An observational study of Spinal Cord Injury, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
Video-urodynamic investigations are regarded as the current standard diagnostics for neurogenic bladder dysfunction in patients with spinal cord injury. This examination is exact, but time consuming, costly and associated with the risk of urinary tract infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- sonographic measurement of bladder wall thickness
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2009to Oct 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: individuals with neurogenic bladder dysfunction due to spinal cord injury
Who may be able to join
- neurogenic bladder dysfunction due to spinal cord injury
- ability to understand German language
- willingness and capability to undergo urodynamic testing
- age > or = 18 years
Who cannot join
- acute urinary infection at the time of examination
- known bladder tumor or bladder stone
- age < 18 years
- not capable to understand aim and purpose of the examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sonographic Measurement of Bladder Wall Thickness in Patients With Neurogenic Bladder Dysfunction Due to Spinal Cord Injury
Video-urodynamic investigations are regarded as the current standard diagnostics for neurogenic bladder dysfunction in patients with spinal cord injury. This examination is exact, but time consuming, costly and associated with the risk of urinary tract infection.
In patients with lower urinary tract symptoms due to benign prostate hyperplasia, sonographic measurement of bladder wall thickness has been demonstrated to be able to replace urodynamic testing for the diagnosis of infravesical obstruction.
Hypothesis: measurement of bladder wall thickness in patients with neurogenic bladder dysfunction due to spinal cord injury is closely related to the known risk factors for upper urinary tract deterioration (bladder compliance, detrusor leak point pressure) in this group of patients and can therefore replace urodynamic examination in selected cases.
- Conditions
- Spinal Cord Injury
- Being tested
- sonographic measurement of bladder wall thickness
- Keywords
- spinal cord injury, urodynamics, ultrasound, neurogenic bladder dysfunction
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sonographic measurement of bladder wall thicknessOther
measurement of bladder wall thickness by ultrasound at different filling states of the bladder during urodynamic investigation
| Study group | Role | What they receive |
|---|---|---|
| one arm; neurogenic bladder dysfunction | evaluation of the clinical utility of bladder wall thickness as a diagnostic tool in patients with spinal cord injury Receives: Other: sonographic measurement of bladder wall thickness |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation bladder wall thickness and detrusor compliance
measurement of detrusor compliance at maximum bladder volume; measurement of bladder wall thickness at maximum bladder volume
Measured: calculated from maximum bladder filling
Secondary outcomes (1)
correlation bladder wall thickness and maximum detrusor pressure
correlation between bladder wall thickness and maximum detrusor pressure during the urodynamic storage phase
Measured: measurement at maximum bladder capacity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startAug 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Juergen Pannek, MD, Principal investigator, Swiss Paraplegic Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299792
- Sponsor's protocol ID
- 2009-07
- Other IDs
- EK900
- Status last verified
- Feb 2024
- First submitted
- 10 Dec 2010
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Measurement of Bladder Wall Thickness in Patients With Neurogenic Bladder Dysfunction Due to Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01299792
- Acronym / sponsor ID
- 2009-07
- Conditions
- Spinal Cord Injury
- Keywords
- spinal cord injury, urodynamics, ultrasound, neurogenic bladder dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- Aug 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 18 Feb 2011 (estimated)
- 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.
Video-urodynamic investigations are regarded as the current standard diagnostics for neurogenic bladder dysfunction in patients with spinal cord injury. This examination is exact, but time consuming, costly and associated with the risk of urinary tract infection.
In patients with lower urinary tract symptoms due to benign prostate hyperplasia, sonographic measurement of bladder wall thickness has been demonstrated to be able to replace urodynamic testing for the diagnosis of infravesical obstruction.
Hypothesis: measurement of bladder wall thickness in patients with neurogenic bladder dysfunction due to spinal cord injury is closely related to the known risk factors for upper urinary tract deterioration (bladder compliance, detrusor leak point pressure) in this group of patients and can therefore replace urodynamic examination in selected cases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one arm; neurogenic bladder dysfunction | – | Other: sonographic measurement of bladder wall thicknessevaluation of the clinical utility of bladder wall thickness as a diagnostic tool in patients with spinal cord injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- individuals with neurogenic bladder dysfunction due to spinal cord injury
Key inclusion criteria (4 listed)
- neurogenic bladder dysfunction due to spinal cord injury
- ability to understand German language
- willingness and capability to undergo urodynamic testing
- age > or = 18 years
Key exclusion criteria (4 listed)
- acute urinary infection at the time of examination
- known bladder tumor or bladder stone
- age < 18 years
- not capable to understand aim and purpose of the examination
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 |
|---|---|---|
| sonographic measurement of bladder wall thicknessmeasurement of bladder wall thickness by ultrasound at different filling states of the bladder during urodynamic investigation | Other | one arm; neurogenic bladder dysfunction |
Primary outcome
correlation bladder wall thickness and detrusor compliance
Time frame: calculated from maximum bladder filling
measurement of detrusor compliance at maximum bladder volume; measurement of bladder wall thickness at maximum bladder volume
1 secondary outcome
correlation bladder wall thickness and maximum detrusor pressure
Time frame: measurement at maximum bladder capacity
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 13 Feb 2024.
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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.
Juergen Pannek, MD principal investigator
Swiss Paraplegic Centre
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 Injury, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
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 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: finished, as of the sponsor's last update on 13 Feb 2024. 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 Switzerland. 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?
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?
correlation bladder wall thickness and detrusor compliance (time frame: calculated from maximum bladder filling). 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 13 Feb 2024.