Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate known urinary biomarkers in order to determine whether they can be predictive of a risk of damage to the upper urinary tract and therefore the kidneys in patients with spina bifida. The risk of damage to the upper urinary tract can be calculated using the Galloway score, based on the results of the urodynamic study and retrograde urethrocystography, which all patients with spina bifida have regularly. The urinary biomarkers studied TIMP-2 (Tissue inhibitor of metalloproteinases 2) and MMP-2 (matrix metalloproteinase-2) are potentially associated with renal degradation, but this has not yet been demonstrated. Volunteers to take part in the study will have their biomarkers measured at the time of their urodynamic assessment.

Official Title
-----------------
Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up

Conditions
-----------------
Spina Bifida

Intervention / Treatment
-----------------
* Biological: Collection of a urine sample
* Diagnostic Test: Magnetic Resonance Imaging of the bladder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spina patients consulted as part of the multidisciplinary consultation of the spina bifida rare disease reference centre; Written consent to participate in the research. Compulsory membership of a social security scheme Exclusion Criteria: Patients with a non-continuous trans ileal urinary diversion ; Patients with enterocystoplasty; Untreated bacteriuria at the time of urodynamic assessment and urine sample collection; History of urinary tract tumour; History of histologically proven interstitial cystitis; Persons under legal protection (safeguard of justice, curatorship, guardianship); Persons deprived of their liberty.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study volunteers<br> | Biological: Collection of a urine sample<br>* Collection of a urine sample for analysis of urinary biomarkers and urinary metabolomics (Inclusion and 1 year)<br>Diagnostic Test: Magnetic Resonance Imaging of the bladder<br>* Magnetic Resonance Imaging of the bladder (10 adults patients only) (Inclusion and 1 year)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We will measure levels of the urinary biomarkers TIMP-2 and MMP-2 and we will report them to explain the Galloway score at the same time. | We will use logistic regression, with the variable to be explained being the Galloway score ≤ 5 or > 5 (a qualitative variable with 2 classes) and the rate of urinary biomarkers as the explanatory variable | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spina Bifida, urinary biomarker, upper urinary tract, Galloway score, urodynamic work-up, urethrocystography