Urinary Bladder Neurogenic DysfunctionNCT01297660
Neuro-urological Outcome After Spinal Cord Injury
An observational study of Urinary Bladder Neurogenic Dysfunction, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
Most patients with spinal cord injury suffer from bladder dysfunction which may - especially in the long-term - impair renal function. Improved treatment during the last decades improved life expectancy and quality of life. This study evaluates the bladder function in the long-term after spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Urinary Bladder Neurogenic Dysfunction
- What is being tested?
- Video-urodynamic examination
- How many people
- 55 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2010to Sep 2010
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ages Eligibility: minimum 18 years old Genders Eligibility: female and male
Who may be able to join
- Spinal cord injury for at least 5 years
- Neurogenic lower urinary tract dysfunction
- Written informed consent
Who cannot join
- Lower urinary tract dysfunction due to other causes than spinal cord injury
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital
Zurich, Canton of Zurich, 8008
About this study
Most patients with spinal cord injury suffer from bladder dysfunction which may - especially in the long-term - impair renal function. Improved treatment during the last decades improved life expectancy and quality of life. This study evaluates the bladder function in the long-term after spinal cord injury.
Read the detailed description
Bladder dysfunction is a common consequence of spinal cord injury and depends on the completeness and the level of the lesion. Patients with suprasacral injury usually suffer from neurogenic detrusor overactivity mostly combined with detrusor sphincter dyssynergia. Without adequate treatment, this adverse combination puts the upper urinary tract at risk due to high intravesical pressure often causing vesico-ureteral reflux. Based on improved therapeutic options in the last decades, life expectancy and quality of life constantly increased in spinal cord injury patients. The investigators aim to evaluate the bladder function in the long-term after spinal cord injury.
- Conditions
- Urinary Bladder Neurogenic Dysfunction
- Being tested
- Video-urodynamic examination
- Keywords
- neurogenic detrusor overactivity, detrusor sphincter dyssynergia, compliance, video urodynamic, spinal cord injury
- Medical subject headings
- Urinary Bladder, Neurogenic, Patient Compliance, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-urodynamic examinationOther
| Study group | Role | What they receive |
|---|---|---|
| patients with SCI for at least 5 years | Ages Eligibility: minimum 18 years Genders Eligibility: female and male Receives: Other: Video-urodynamic examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urodynamic evaluation
Max. cystometric capacity, compliance, detrusor leak point pressure
Measured: 5 years after SCI, yearly thereafter (participants are followed until death)
Secondary outcomes (2)
secondary complications
recurrent tract infection, deterioration of the upper urinary tract
Measured: 5 years after SCI, yearly thereafter (participants are followed until death)
imaging of the upper urinary tract
videocystography, ultrasound
Measured: 5 years after SCI, yearly thereafter (participants are followed until death)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startJan 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder Neurogenic DysfunctionStudies 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
- Retrospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Kessler, Balgrist University Hospital
- Investigators
- Jens Wöllner, Dr. med., Principal investigator, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297660
- Sponsor's protocol ID
- KEK-2010-0207/01
- Status last verified
- Dec 2016
- First submitted
- 16 Feb 2011
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuro-urological Outcome After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01297660
- Acronym / sponsor ID
- KEK-2010-0207/01
- Conditions
- Urinary Bladder Neurogenic Dysfunction
- Keywords
- neurogenic detrusor overactivity, detrusor sphincter dyssynergia, compliance, video urodynamic, spinal cord injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 17 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.
Most patients with spinal cord injury suffer from bladder dysfunction which may - especially in the long-term - impair renal function. Improved treatment during the last decades improved life expectancy and quality of life. This study evaluates the bladder function in the long-term after spinal cord injury.
Detailed description
Bladder dysfunction is a common consequence of spinal cord injury and depends on the completeness and the level of the lesion. Patients with suprasacral injury usually suffer from neurogenic detrusor overactivity mostly combined with detrusor sphincter dyssynergia. Without adequate treatment, this adverse combination puts the upper urinary tract at risk due to high intravesical pressure often causing vesico-ureteral reflux. Based on improved therapeutic options in the last decades, life expectancy and quality of life constantly increased in spinal cord injury patients. The investigators aim to evaluate the bladder function in the long-term after spinal cord injury.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with SCI for at least 5 years | – | Other: Video-urodynamic examinationAges Eligibility: minimum 18 years Genders Eligibility: female and male |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ages Eligibility: minimum 18 years old Genders Eligibility: female and male
Key inclusion criteria (3 listed)
- Spinal cord injury for at least 5 years
- Neurogenic lower urinary tract dysfunction
- Written informed consent
Key exclusion criteria (1 listed)
- Lower urinary tract dysfunction due to other causes than spinal cord injury
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 |
|---|---|---|
| Video-urodynamic examination | Other | patients with SCI for at least 5 years |
Primary outcome
Urodynamic evaluation
Time frame: 5 years after SCI, yearly thereafter (participants are followed until death)
Max. cystometric capacity, compliance, detrusor leak point pressure
2 secondary outcomes
secondary complications
Time frame: 5 years after SCI, yearly thereafter (participants are followed until death)
imaging of the upper urinary tract
Time frame: 5 years after SCI, yearly thereafter (participants are followed until death)
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 16 Dec 2016.
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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.
Jens Wöllner, Dr. med. principal investigator
Balgrist University Hospital
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 Urinary Bladder Neurogenic Dysfunction, run by Balgrist University Hospital 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 3 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 16 Dec 2016. 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?
Urodynamic evaluation (time frame: 5 years after SCI, yearly thereafter (participants are followed until death)). 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 16 Dec 2016.