Somatosensory Evoked Potentials From the Lower Urinary Tract

NCT ID: NCT02449512

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-12-31

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.

Conditions

Neurogenic Lower Urinary Tract Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

complete

individuals with somato-sensory complete spinal cord injury

No interventions assigned to this group

incomplete

individuals with somato-sensory incomplete spinal cord injury

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss Paraplegic Research, Nottwil

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jens Wöllner

Role: PRINCIPAL_INVESTIGATOR

Swiss Paraplegic Centre

Locations

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, Switzerland

Countries

Switzerland

Other Identifiers

2014-20

Identifier Type: -

Identifier Source: org_study_id