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Recruiting NCT06041334

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

Trial Parameters

Condition Spina Bifida
Sponsor Rennes University Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 50
Sex ALL
Min Age 6 Years
Max Age N/A
Start Date 2024-01-18
Completion 2027-07-18
Interventions
Collection of a urine sampleMagnetic Resonance Imaging of the bladder

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.

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. * Women claiming to be pregnant

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