Clinical trial NCT02449512: Somatosensory Evoked Potentials From the Lower Urinary Tract
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
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Neurogenic Lower Urinary Tract Dysfunction
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2015-05-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: individuals with neurogenic lower urinary tract dysfunction as a result of spinal cord injury

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.


Eligibility criteria: 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
* Exclusion criteria for MRI (cardiac pace maker, implanted metal etc.)

Primary outcomes:
measure: occurrence of somatosensory evoked potentials from the bladder
timeFrame: within 1 week after enrollment into study
Secondary outcomes:
measure: latency of somatosensory evoked potentials
timeFrame: within 1 week after enrollment into study
measure: peak-to-peak amplitude of somatosensory evoked potentials
timeFrame: within 1 week after enrollment into study
measure: nerve fiber density around bladder
timeFrame: within 1 week after enrollment into study
measure: fractional anisotropy of nerve fibers around bladder
timeFrame: within 1 week after enrollment into study
measure: apparent diffusion coefficient of nerve fibers around bladder
timeFrame: within 1 week after enrollment into study
Other outcomes:
measure: age
timeFrame: 1st day
measure: gender
timeFrame: 1st day
measure: severity of spinal cord injury
timeFrame: 1st day
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: LU
Study officials:
affiliation: Swiss Paraplegic Centre
name: Jens Wöllner
role: PRINCIPAL_INVESTIGATOR
References: