About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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;
Trial design
Single group
Treatments tested in this trial
Collection of a urine sample
Biological/VaccineCollection of a urine sample for analysis of urinary biomarkers and urinary metabolomics (Inclusion and 1 year)
Magnetic Resonance Imaging of the bladder
Diagnostic testMagnetic Resonance Imaging of the bladder (10 adults patients only) (Inclusion and 1 year)
Treatment groups
Trial outcomes
Primary outcomes
Verify if levels of urinary biomarkers Metalloproteinase Inhibitor 2 and matrix metalloproteinase-2 are associated with Galloway score
Logistic regression based on composite analysis of Galloway score (≤ 5 (low risk) or \>5 (high risk)) and the rate of urinary biomarkers.
Secondary outcomes
Galloway score
Change in Galloway score from baseline to 1 year based on change in urinary biomarkers Metalloproteinase Inhibitor 2 and matrix metalloproteinase-2
Success or failure of treatment
The success of the treatment will be assessed at 1 year after its implementation according to an hybrid criteria : In the event of a Patients Global Impression of Improvement for Incontinence questionnaire \< 3 and/or a Galloway score reduction of 1 or 2, the treatment will be considered successful.
Relationship between the success of the treatment implemented at inclusion and the level of urinary biomarkers
The relationship between the success of the treatment implemented at inclusion and the level of the urinary biomarkers Metalloproteinase Inhibitor 2 Anticorps and matrix metalloproteinase-2 at inclusion will be studied.
Bladder hypocompliance based on metabolomic profile at inclusion
Presence or absence of bladder hypocompliance on urodynamic assessment at baseline, based on metabolomic profile at baseline.
Sponsors and contacts
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Rennes University Hospital
Lead sponsor
NeuroSphinx
Collaborator