Somatosensory Evoked Potentials From the Lower Urinary Tract

Neurogenic Lower Urinary Tract Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02449512
• Other study ID #: 2014-20
• Status: Suspended
• Start date: January 2026
• Est. completion date: December 2028

Study information

• Verified date: June 2024
• Source: Swiss Paraplegic Research, Nottwil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 24
• Est. completion date: December 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Neurogenic Lower Urinary Tract Dysfunction

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre	Nottwil	LU

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Research, Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	age		1st day
Other	gender		1st day
Other	severity of spinal cord injury	American Association of Spinal Cord Injury Impairment Score	1st day
Primary	occurrence of somatosensory evoked potentials from the bladder		within 1 week after enrollment into study
Secondary	latency of somatosensory evoked potentials		within 1 week after enrollment into study
Secondary	peak-to-peak amplitude of somatosensory evoked potentials		within 1 week after enrollment into study
Secondary	nerve fiber density around bladder		within 1 week after enrollment into study
Secondary	fractional anisotropy of nerve fibers around bladder		within 1 week after enrollment into study
Secondary	apparent diffusion coefficient of nerve fibers around bladder		within 1 week after enrollment into study