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Somatosensory Evoked Potentials From the Lower Urinary Tract

Somatosensory Evoked Potentials From the Lower Urinary Tract in Individuals With Neurogenic Lower Urinary Tract Dysfunction as a Result of Spinal Cord Injury

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02449512
Enrollment
0
Registered
2015-05-20
Start date
2026-01-31
Completion date
2028-12-31
Last updated
2025-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurogenic Lower Urinary Tract Dysfunction

Brief 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. 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.

Interventions

None listed

Sponsors

Swiss Paraplegic Research, Nottwil
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Informed Consent as documented by signature * Chronic SCI of a minimum of 1 year * Aetiology of SCI: traumatic

Exclusion criteria

* 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) * Bladder augmentation * Sacral deafferentation * Sacral neuromodulation * Acute, symptomatic urinary tract infection * Pregnancy * Urolithiasis * Bladder cancer *

Design outcomes

Primary

MeasureTime frame
occurrence of somatosensory evoked potentials from the bladderwithin 1 week after enrollment into study

Secondary

MeasureTime frame
peak-to-peak amplitude of somatosensory evoked potentialswithin 1 week after enrollment into study
nerve fiber density around bladderwithin 1 week after enrollment into study
fractional anisotropy of nerve fibers around bladderwithin 1 week after enrollment into study
apparent diffusion coefficient of nerve fibers around bladderwithin 1 week after enrollment into study
latency of somatosensory evoked potentialswithin 1 week after enrollment into study

Other

MeasureTime frameDescription
severity of spinal cord injury1st dayAmerican Association of Spinal Cord Injury Impairment Score
gender1st day
age1st day

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026