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

Last updated: January 20, 2025
Sponsor: Rennes University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Magnetic Resonance Imaging of the bladder

Collection of a urine sample

Clinical Study ID

NCT06041334
35RC20_9746_SPINLESS
IDRCB
  • Ages > 6
  • All Genders

Study 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

Inclusion Criteria:

  • Spina patients consulted as part of the multidisciplinary consultation of the spinabifida rare disease reference centre;

  • Written consent to participate in the research.

  • Compulsory membership of a social security scheme

Exclusion

Exclusion Criteria:

  • Patients with a non-continuous trans ileal urinary diversion ;

  • Patients with enterocystoplasty;

  • Untreated bacteriuria at the time of urodynamic assessment and urine samplecollection;

  • 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

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Magnetic Resonance Imaging of the bladder
Phase:
Study Start date:
January 18, 2024
Estimated Completion Date:
January 18, 2027

Connect with a study center

  • Rennes University Hospital

    Rennes cedex 9, CHU de Rennes 35033
    France

    Active - Recruiting

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