Neurogenic Lower Urinary Tract DysfunctionNCT02449512
Somatosensory Evoked Potentials From the Lower Urinary Tract
An observational study of Neurogenic Lower Urinary Tract Dysfunction, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
Spinal cord injury and other systemic neurological diseases (Multiple Sclerosis, Parkinson's disease) affect the integrity of lower urinary tract (LUT) function, leading to neurogenic lower urinary tract dysfunction (NLUTD). The urodynamic investigation is the current "gold-standard" for evaluating LUT function. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Neurogenic Lower Urinary Tract Dysfunction
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2026to Dec 2028
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: individuals with neurogenic lower urinary tract dysfunction as a result of spinal cord injury
Who may be able to join
- Informed Consent as documented by signature
- Chronic SCI of a minimum of 1 year
- Aetiology of SCI: traumatic
Who cannot join
- Age < 18 years or > 70 years
- Aetiology of SCI: non-traumatic
- History of bleeding disorder
- History of chronic neuropathic pain
- Intravesical botulinum toxin injections < 12 months ago
- Bladder management using indwelling catheters (suprapubic, transurethral)
Show all 14Show fewer
- Bladder augmentation
- Sacral deafferentation
- Sacral neuromodulation
- Acute, symptomatic urinary tract infection
- Pregnancy
- Urolithiasis
- Bladder cancer
- Exclusion criteria for MRI (cardiac pace maker, implanted metal etc.)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, CH-6207
About this study
Official title: Somatosensory Evoked Potentials From the Lower Urinary Tract in Individuals With Neurogenic Lower Urinary Tract Dysfunction as a Result of Spinal Cord Injury
Spinal cord injury and other systemic neurological diseases (Multiple Sclerosis, Parkinson's disease) affect the integrity of lower urinary tract (LUT) function, leading to neurogenic lower urinary tract dysfunction (NLUTD). The urodynamic investigation is the current "gold-standard" for evaluating LUT function. Nevertheless, the sensory situation of the LUT cannot be investigated objectively. Furthermore, the current classification of the severity of the NLUTD due to spinal cord injury (SCI) does not represent the sensory situation of the LUT. Additional investigations therefore need to be established for assessing the sensory situation of the LUT. Somatosensory evoked potentials (SEPs) are an established method for investigating the processing of sensory nervous activity. However, SEPs from the LUT of SCI individuals have not yet been investigated.
A novel technique, i.e. diffusion tensor imaging (DTI), allows to process magnetic resonance images (MRI) in order to visualize nerve fibers. Using DTI, the innervation of the bladder after SCI can be visualized. The structural presentation of bladder innervation will be compared with the functional results, i.e. the SEP of the LUT in SCI individuals.
Read more
The primary objective of the proposed study is to elicit and characterize (latency, amplitude) the somatosensory evoked potentials (SEPs) from the bladder in individuals suffering from neurogenic lower urinary tract dysfunction as a result of spinal cord injury.
Furthermore, the SEPs from the bladder will be compared with the SEPs from peripheral nerves (N. tibialis, N. pudendus, N. medianus).
Moreover, the latency and amplitude of the SEPs from the bladder of individuals with somato-sensory complete spinal cord injury will be compared with those from the bladder of individuals with somato-sensory incomplete spinal cord injury.
Finally, the structural innervation of the bladder after SCI will be compared with the remaining sensory function.
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 |
|---|---|---|
| complete | individuals with somato-sensory complete spinal cord injury | |
| incomplete | individuals with somato-sensory incomplete spinal cord injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of somatosensory evoked potentials from the bladder
Measured: within 1 week after enrollment into study
Secondary outcomes (5)
latency of somatosensory evoked potentials
Measured: within 1 week after enrollment into study
peak-to-peak amplitude of somatosensory evoked potentials
Measured: within 1 week after enrollment into study
nerve fiber density around bladder
Measured: within 1 week after enrollment into study
fractional anisotropy of nerve fibers around bladder
Measured: within 1 week after enrollment into study
apparent diffusion coefficient of nerve fibers around bladder
Measured: within 1 week after enrollment into study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startJan 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Why it stopped: Funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic Lower Urinary Tract 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jens Wöllner, Principal investigator, Swiss Paraplegic Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449512
- Sponsor's protocol ID
- 2014-20
- Status last verified
- Jul 2025
- First submitted
- 15 May 2015
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatosensory Evoked Potentials From the Lower Urinary Tract in Individuals With Neurogenic Lower Urinary Tract Dysfunction as a Result of Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02449512
- Acronym / sponsor ID
- 2014-20
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 May 2015 (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.
Spinal cord injury and other systemic neurological diseases (Multiple Sclerosis, Parkinson's disease) affect the integrity of lower urinary tract (LUT) function, leading to neurogenic lower urinary tract dysfunction (NLUTD). The urodynamic investigation is the current "gold-standard" for evaluating LUT function. Nevertheless, the sensory situation of the LUT cannot be investigated objectively. Furthermore, the current classification of the severity of the NLUTD due to spinal cord injury (SCI) does not represent the sensory situation of the LUT. Additional investigations therefore need to be established for assessing the sensory situation of the LUT. Somatosensory evoked potentials (SEPs) are an established method for investigating the processing of sensory nervous activity. However, SEPs from the LUT of SCI individuals have not yet been investigated.
A novel technique, i.e. diffusion tensor imaging (DTI), allows to process magnetic resonance images (MRI) in order to visualize nerve fibers. Using DTI, the innervation of the bladder after SCI can be visualized. The structural presentation of bladder innervation will be compared with the functional results, i.e. the SEP of the LUT in SCI individuals.
The primary objective of the proposed study is to elicit and characterize (latency, amplitude) the somatosensory evoked potentials (SEPs) from the bladder in individuals suffering from neurogenic lower urinary tract dysfunction as a result of spinal cord injury.
Furthermore, the SEPs from the bladder will be compared with the SEPs from peripheral nerves (N. tibialis, N. pudendus, N. medianus).
Moreover, the latency and amplitude of the SEPs from the bladder of individuals with somato-sensory complete spinal cord injury will be compared with those from the bladder of individuals with somato-sensory incomplete spinal cord injury.
Finally, the structural innervation of the bladder after SCI will be compared with the remaining sensory function.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| complete | – | –individuals with somato-sensory complete spinal cord injury |
| incomplete | – | –individuals with somato-sensory incomplete spinal cord injury |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- individuals with neurogenic lower urinary tract dysfunction as a result of spinal cord injury
Key inclusion criteria (3 listed)
- Informed Consent as documented by signature
- Chronic SCI of a minimum of 1 year
- Aetiology of SCI: traumatic
Key exclusion criteria (14 listed)
- Age < 18 years or > 70 years
- Aetiology of SCI: non-traumatic
- History of bleeding disorder
- History of chronic neuropathic pain
- Intravesical botulinum toxin injections < 12 months ago
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
occurrence of somatosensory evoked potentials from the bladder
Time frame: within 1 week after enrollment into study
5 secondary outcomes
latency of somatosensory evoked potentials
Time frame: within 1 week after enrollment into study
peak-to-peak amplitude of somatosensory evoked potentials
Time frame: within 1 week after enrollment into study
nerve fiber density around bladder
Time frame: within 1 week after enrollment into study
fractional anisotropy of nerve fibers around bladder
Time frame: within 1 week after enrollment into study
apparent diffusion coefficient of nerve fibers around bladder
Time frame: within 1 week after enrollment into study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Neurogenic Lower Urinary Tract Dysfunction
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Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis
RecruitingPhase 2
CBD for Lower Urinary Tract Dysfunction in Spinal Cord Injury
Supra-sacral Spinal Cord Injury, Spinal Cord Injury
Not yet recruiting
Rapid UTI Diagnostics in Lower Urinary Tract Dysfunction Among Catheter Users
Neurogenic Bladder Disorder, Lower Urinary Tract Disorder
Not yet recruitingEarly Phase 1
Coupled Gentamicin-Lactobacillus Rhamnosus in NLUTD
Spinal Cord Injury, Neurogenic Bladder (NB)
Not yet recruiting
Radio-frequency (RF) Bladder Monitor
Spinal Cord Injuries (SCI), Neurogenic Lower Urinary Tract Dysfunction
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 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 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 3 inclusion and 14 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: withdrawn, as of the sponsor's last update on 31 Jul 2025. 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 was withdrawn before enrolling participants, so there are no results.
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?
occurrence of somatosensory evoked potentials from the bladder (time frame: within 1 week after enrollment into study). 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 31 Jul 2025.