Somatosensory Evoked Potentials From the Lower Urinary Tract

NCT02449512 | Withdrawn

• 1 other identifier: 2014-20
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• occurrence of somatosensory evoked potentials from the bladder

  within 1 week after enrollment into study

Secondary Outcomes (5)

• 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 Outcomes (3)

• age

  1st day

• gender

  1st day

• severity of spinal cord injury

  1st day

Study Arms (2)

complete

individuals with somato-sensory complete spinal cord injury

incomplete

individuals with somato-sensory incomplete spinal cord injury

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, CH-6207, Switzerland

Location

Study Officials

• Jens Wöllner

  Swiss Paraplegic Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2015
• First Posted: May 20, 2015
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)