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

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 Overview

• Status: Withdrawn
• Conditions: Neurogenic Lower Urinary Tract Dysfunction

• Study Type: Observational

Contacts and Locations

Study Locations

• Switzerland
  • LU
    • Nottwil, LU, Switzerland, CH-6207
      • Swiss Paraplegic Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

individuals with neurogenic lower urinary tract dysfunction as a result of spinal cord injury

Description

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.)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
complete; individuals with somato-sensory complete spinal cord injury
incomplete; individuals with somato-sensory incomplete spinal cord injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
occurrence of somatosensory evoked potentials from the bladder	within 1 week after enrollment into study

Secondary Outcome Measures

Outcome Measure	Time Frame
latency of somatosensory evoked potentials	within 1 week after enrollment into study
peak-to-peak amplitude of somatosensory evoked potentials	within 1 week after enrollment into study
nerve fiber density around bladder	within 1 week after enrollment into study
fractional anisotropy of nerve fibers around bladder	within 1 week after enrollment into study
apparent diffusion coefficient of nerve fibers around bladder	within 1 week after enrollment into study

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
age		1st day
gender		1st day
severity of spinal cord injury	American Association of Spinal Cord Injury Impairment Score	1st day

Collaborators and Investigators

• Sponsor: Swiss Paraplegic Research, Nottwil
• Investigators: Principal Investigator: Jens Wöllner, Swiss Paraplegic Centre

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 15, 2015
• First Submitted That Met QC Criteria: May 15, 2015
• First Posted (Estimated): May 20, 2015

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2014-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO