Actively Recruiting

Phase Not Applicable
Age: 6Years +
All Genders
NCT06041334

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

Led by Rennes University Hospital · Updated on 2025-12-22

50

Participants Needed

1

Research Sites

234 weeks

Total Duration

On this page

Sponsors

R

Rennes University Hospital

Lead Sponsor

N

NeuroSphinx

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 6Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Spina bifida patients seen in the multidisciplinary consultation of the spina bifida rare disease reference centre
  • Written consent to participate in the research
  • Must have compulsory membership of a social security scheme
Not Eligible

You will not qualify if you...

  • 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 such as safeguard of justice, curatorship, or guardianship
  • Persons deprived of their liberty
  • Women who are pregnant

AI-Screening

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Trial Site Locations

Total: 1 location

1

Rennes University Hospital

Rennes, CHU de Rennes, France, 35033

Actively Recruiting

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Research Team

L

LOÏC JACOB

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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