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MRI of the sacral plexus and sacral nerve roots in children with neurogenous bladder dysfunction with sacral or spinal anomalies

MRI of the sacral plexus and sacral nerve roots in children with neurogenous bladder dysfunction with sacral or spinal anomalies - MRI of the sacral plexus in children

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON37843
Enrollment
10
Registered
2012-06-13
Start date
2012-11-14
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bladder dysfunction spinal dysraphism

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: age > 8 years diagnosed with spinal dysraphism or sacral anomalies and neurogenous bladder which are already scheduled to have a MRI scan for diagnostic reasons. Parents/guardian and child >12 years need to be able and willing to sign informed consent

Exclusion criteria

Exclusion criteria: contra indication of MRI (i.e. claustrofobia, pacemaker) Parents/guardian and child don't want to be informed of accidental findings Children of employees of the divisions Paediatric Urology and Radiology of the UMC Utrecht

Design outcomes

Primary

MeasureTime frame
The primary study parameter is the anatomy and organisation of the sacral plexus in the patient population in comparison to the organisation in healthy individuals (from study 10/418). In order to be able to answer this question, the anatomy and organisation of the sacral plexus in the patient group will be compared qualitatively with the gained anatomical knowledge of the sacral plexus from the previous healthy subject study. The hypothesis is that in children with Spina Bifida a disrupted organisation of the nerves will be revealed. In children with sacral agenesis a disrupted course of the nerves is expected, because the sacrum has a disrupted development. In order to further validate and quantify findings regarding anatomy and organization of the sacral plexus, two secondary parameters will also be used, these are described below.

Secondary

MeasureTime frame
1) The anatomy of nerve branching in the sacral plexus Branching of the nerve root is analyzed: no branching, branching in two branches or plexiform branching of the nerve root. This outcome will be related to the healthy subjects quantitatively by means of comparative statistics. 2) Determining the ADC, FA, AD and RD The parameters mentioned above will be used to quantify the DTI images. Molecular diffusion in the nerves can be characterized with these parameters. Furthermore, quantitative comparison between the values for these parameters and the reference values of the healthy subjects is possible. However, myelinisation differences between children and adolescents, and the influence of these differences on the parameters, need to be taken into account in comparison between both groups. ExploreDTI by Alexander Leemans (Image Science Institute, Utrecht), will be used to measure ADC, FA, AD and RD. The number of images we're not able to analyse will also be determined.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)