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

ConditionSpina Bifida
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorRennes University Hospital

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

Qualifiers

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

Treatments tested in this trial

  • Collection of a urine sample
  • Magnetic Resonance Imaging of the bladder

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators