Spinal Cord InjuryNCT02138201
Representation of the Bladder Innervation Using Diffusion Tensor Imaging Fiber Tracking With MRI - a Pilot Study
An observational study of Spinal Cord Injury and Neurogenic Lower Urinary Tract Dysfunction, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
The exact innervation of the bladder and the changes after a spinal cord injury have been not yet been illustrated. Diffusion tensor imaging with magnetic resonance imaging is a new technique which can be used to visualize single nerve fibers, and thus represent the neural supply of a region in vivo. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury, Neurogenic Lower Urinary Tract Dysfunction
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2014to Nov 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: individuals with and without neurogenic lower urinary trat dysfunction
Who may be able to join
- neurogenic lower urinary trat dysfunction
- normal bladder function
Who cannot join
- no signed informed consent
- contraindications for MRI (pace maker, implanted metal, claustrophobia)
- upper or lower urinary tract surgeries
- pregnancy (anamnestic)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, CH-6207
About this study
The exact innervation of the bladder and the changes after a spinal cord injury have been not yet been illustrated.
Diffusion tensor imaging with magnetic resonance imaging is a new technique which can be used to visualize single nerve fibers, and thus represent the neural supply of a region in vivo. There are studies in which both the sacral plexus and the lumbar nerve roots have been represented using diffusion tensor imaging. However, there is no study concerning the innervation of the bladder.
The investigators are therefore using diffusion tensor imaging with magnetic resonance imaging to represent the bladder innervation of individuals with neurogenic lower urinary tract dysfunction and individuals with normal bladder function.
- Keywords
- diffusion tensor imaging fiber tracking, magnetic resonance Imaging, spinal cord injury, neurogenic lower urinary tract 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.
| Study group | Role | What they receive |
|---|---|---|
| control | individuals with normal bladder function | |
| neurogenic bladder | individuals suffering from neurogenic lower urinary tract dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
bladder innervation quality
bladder innervation is illustrated using diffusion tensor imaging fiber tracking with magnetic resonance imaging
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startJan 2014
- Primary completionNov 2015
- Study completionNov 2015
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
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138201
- Sponsor's protocol ID
- 2013-25
- Status last verified
- Nov 2015
- First submitted
- 5 May 2014
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Representation of the Bladder Innervation Using Diffusion Tensor Imaging Fiber Tracking With MRI - a Pilot Study
- ClinicalTrials.gov ID
- NCT02138201
- Acronym / sponsor ID
- 2013-25
- Keywords
- diffusion tensor imaging fiber tracking, magnetic resonance Imaging, spinal cord injury, neurogenic lower urinary tract dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- Jan 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 14 May 2014 (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 exact innervation of the bladder and the changes after a spinal cord injury have been not yet been illustrated.
Diffusion tensor imaging with magnetic resonance imaging is a new technique which can be used to visualize single nerve fibers, and thus represent the neural supply of a region in vivo. There are studies in which both the sacral plexus and the lumbar nerve roots have been represented using diffusion tensor imaging. However, there is no study concerning the innervation of the bladder.
The investigators are therefore using diffusion tensor imaging with magnetic resonance imaging to represent the bladder innervation of individuals with neurogenic lower urinary tract dysfunction and individuals with normal bladder function.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | –individuals with normal bladder function |
| neurogenic bladder | – | –individuals suffering from neurogenic lower urinary tract dysfunction |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- individuals with and without neurogenic lower urinary trat dysfunction
Key inclusion criteria (2 listed)
- neurogenic lower urinary trat dysfunction
- normal bladder function
Key exclusion criteria (4 listed)
- no signed informed consent
- contraindications for MRI (pace maker, implanted metal, claustrophobia)
- upper or lower urinary tract surgeries
- pregnancy (anamnestic)
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
bladder innervation quality
Time frame: day 0
bladder innervation is illustrated using diffusion tensor imaging fiber tracking with magnetic resonance imaging
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 17 Nov 2015.
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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 Spinal Cord Injury and Neurogenic Lower Urinary Tract Dysfunction, 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 2 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 17 Nov 2015. 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?
bladder innervation quality (time frame: day 0). 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 17 Nov 2015; AzTrials last refreshed its copy on 28 Oct 2026.