NCT02138201

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 14, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

1.8 years

First QC Date

May 5, 2014

Last Update Submit

November 16, 2015

Conditions

Keywords

diffusion tensor imaging fiber trackingmagnetic resonance Imagingspinal cord injuryneurogenic lower urinary tract dysfunction

Outcome Measures

Primary Outcomes (1)

  • bladder innervation quality

    bladder innervation is illustrated using diffusion tensor imaging fiber tracking with magnetic resonance imaging

    day 0

Study Arms (2)

control

individuals with normal bladder function

neurogenic bladder

individuals suffering from neurogenic lower urinary tract dysfunction

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

individuals with and without neurogenic lower urinary trat dysfunction

You may qualify if:

  • neurogenic lower urinary trat dysfunction
  • normal bladder function

You may not qualify if:

  • no signed informed consent
  • contraindications for MRI (pace maker, implanted metal, claustrophobia)
  • upper or lower urinary tract surgeries
  • pregnancy (anamnestic)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, CH-6207, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2014

First Posted

May 14, 2014

Study Start

January 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations