NCT06041334

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spina Bifida

Interventions

Type	Name	Description
BIOLOGICAL	Collection of a urine sample	Collection of a urine sample for analysis of urinary biomarkers and urinary metabolomics (Inclusion and 1 year)
DIAGNOSTIC_TEST	Magnetic Resonance Imaging of the bladder	Magnetic Resonance Imaging of the bladder (10 adults patients only) (Inclusion and 1 year)

Timeline

• Start date: 2024-01-18
• Primary completion: 2027-07-18
• Completion: 2028-07-18
• First posted: 2023-09-18
• Last updated: 2025-12-22

Locations

1 site across 1 country: France