Representation of the Bladder Innervation Using Diffusion Tensor Imaging Fiber Tracking With MRI - a Pilot Study

Spinal Cord Injury Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02138201
• Other study ID #: 2013-25
• Status: Completed
• Phase: N/A
• First received: May 5, 2014
• Last updated: November 16, 2015
• Start date: January 2014
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Swiss Paraplegic Centre Nottwil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Observational

Clinical Trial Summary

The exact innervation of the bladder and the changes after a spinal cord injury have been not yet been illustrated.

Diffusion tensor imaging with magnetic resonance imaging is a new technique which can be used to visualize single nerve fibers, and thus represent the neural supply of a region in vivo. There are studies in which both the sacral plexus and the lumbar nerve roots have been represented using diffusion tensor imaging. However, there is no study concerning the innervation of the bladder.

The investigators are therefore using diffusion tensor imaging with magnetic resonance imaging to represent the bladder innervation of individuals with neurogenic lower urinary tract dysfunction and individuals with normal bladder function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• neurogenic lower urinary trat dysfunction

• normal bladder function

Exclusion Criteria:

• no signed informed consent

• contraindications for MRI (pace maker, implanted metal, claustrophobia)

• upper or lower urinary tract surgeries

• pregnancy (anamnestic)

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Neurogenic Lower Urinary Tract Dysfunction
• Spinal Cord Injuries
• Spinal Cord Injury

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre	Nottwil	LU

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Centre Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bladder innervation quality	bladder innervation is illustrated using diffusion tensor imaging fiber tracking with magnetic resonance imaging	day 0	No