Vesico-ureteral RefluxNCT01297673
Reflux in Spinal Cord Injury Patients With Neurogenic Lower Urinary Tract Dysfunction
An observational study of Vesico-ureteral Reflux and Spinal Cord Injury, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
The purpose of this study is to investigate the incidence of reflux in patients with spinal cord injury in relation to the lesion level, duration of injury and bladder management Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Vesico-ureteral Reflux, Spinal Cord Injury
- What is being tested?
- video-urodynamic examination
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2010to Aug 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 Genders Eligibility: female and male
Who may be able to join
- Spinal cord injury
- 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
Official title: Vesico-ureteral Reflux in a Contemporary Series of Spinal Cord Injury Patients With Neurogenic Lower Urinary Tract Dysfunction
The purpose of this study is to investigate the incidence of reflux in patients with spinal cord injury in relation to the lesion level, duration of injury and bladder management
Read the detailed description
Vesico-ureteral reflux was the main cause for renal failure and reduced life expectancy in patients with neurogenic bladder dysfunction due to spinal cord injury. Neurogenic detrusor overactivity leads to high intravesical pressure and may induce reflux. Decreasing intravesical pressure and increasing bladder capacity is necessary to prevent reflux and secondary renal failure.
- Conditions
- Vesico-ureteral Reflux, Spinal Cord Injury
- Being tested
- video-urodynamic examination
- Keywords
- vesico-ureteral reflux, neurogenic bladder dysfunction, spinal cord injury
- Medical subject headings
- Vesico-Ureteral Reflux, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video-urodynamic examinationProcedure or surgery
Assessment of bladder function during video urodynamic determine of incidence degree and localization of vesico ureteral reflux based on the result of video urodynamics
| Study group | Role | What they receive |
|---|---|---|
| Spinal cord injury | Patients with neurogenic lower urinary tract dysfunction due to spinal cord injury with regular urodynamic examination Receives: Procedure: video-urodynamic examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and degree of vesico ureter renal reflux
video urodynamic, ultrasound examination
Measured: average: yearly scheduled control
Secondary outcomes (6)
pdet (cmH2O)
urodynamic parameter, detrusor pressure
Measured: average: yearly scheduled control
Medication
name of drugs and applied dosis
Measured: average: yearly scheduled examination
possible complications
urinary tract infection, pyelonephritis, renal dysfunction
Measured: average: yearly scheduled examination
maximum cystometric capacity
the volume at which a patient, with normal sensation, fells he/she can no longer delay micturition
Measured: average: yearly scheduled control
compliance mL/cmH2O
Compliance is the change in volume divided by change in detrusor pressure expressed as mL/cmH2O.
Measured: average: yearly scheduled control
bladder management
most common: intermittent catheterisation, indwelling catheter, external condom urinal for male patients
Measured: average: yearly scheduled control
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 completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vesico-ureteral RefluxStudies 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
- 120 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297673
- Sponsor's protocol ID
- EK 2010-0207/02
- 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
- Vesico-ureteral Reflux in a Contemporary Series of Spinal Cord Injury Patients With Neurogenic Lower Urinary Tract Dysfunction
- ClinicalTrials.gov ID
- NCT01297673
- Acronym / sponsor ID
- EK 2010-0207/02
- Conditions
- Vesico-ureteral Reflux, Spinal Cord Injury
- Keywords
- vesico-ureteral reflux, neurogenic bladder dysfunction, spinal cord injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 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.
The purpose of this study is to investigate the incidence of reflux in patients with spinal cord injury in relation to the lesion level, duration of injury and bladder management
Detailed description
Vesico-ureteral reflux was the main cause for renal failure and reduced life expectancy in patients with neurogenic bladder dysfunction due to spinal cord injury. Neurogenic detrusor overactivity leads to high intravesical pressure and may induce reflux. Decreasing intravesical pressure and increasing bladder capacity is necessary to prevent reflux and secondary renal failure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal cord injury | – | Procedure: video-urodynamic examinationPatients with neurogenic lower urinary tract dysfunction due to spinal cord injury with regular urodynamic examination |
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 Genders Eligibility: female and male
Key inclusion criteria (3 listed)
- Spinal cord injury
- 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 examinationAssessment of bladder function during video urodynamic determine of incidence degree and localization of vesico ureteral reflux based on the result of video urodynamics | Procedure or surgery | Spinal cord injury |
Primary outcome
Incidence and degree of vesico ureter renal reflux
Time frame: average: yearly scheduled control
video urodynamic, ultrasound examination
6 secondary outcomes
pdet (cmH2O)
Time frame: average: yearly scheduled control
Medication
Time frame: average: yearly scheduled examination
possible complications
Time frame: average: yearly scheduled examination
maximum cystometric capacity
Time frame: average: yearly scheduled control
compliance mL/cmH2O
Time frame: average: yearly scheduled control
bladder management
Time frame: average: yearly scheduled control
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Vesico-ureteral Reflux and Spinal Cord Injury, 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?
Incidence and degree of vesico ureter renal reflux (time frame: average: yearly scheduled control). 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.