Clinical trial Recruiting at 1 site Interventional Ages 6 and up

Evaluating urinary biomarkers in spina bifida patients

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

Run by Rennes University Hospital · NCT06041334 · Data updated 2026-11-12

This study is testing if certain urine markers can help predict kidney damage in people with spina bifida during their regular check-ups.

Quick facts

Study typeInterventional
Ages6 Years and up
SexAll
Enrollment50 (estimated)
SponsorRennes University Hospital
Academic / other
Locations1 site (Rennes, CHU de Rennes)
StatusRecruiting
StartedJanuary 18, 2024
Main results expectedJuly 18, 2027
Study endsJuly 18, 2028
Registry record updatedDecember 22, 2025
Trial IDNCT06041334 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients with spina bifida who are undergoing regular multidisciplinary consultations at a rare disease reference center.

Probably not a fit

Patients with certain urinary diversions, untreated infections, or specific urinary tract histories may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the potential of urinary biomarkers, specifically TIMP-2 and MMP-2, to predict the risk of upper urinary tract damage in patients with spina bifida. Participants will have their biomarkers measured during routine urodynamic assessments, which are part of their regular follow-up care. The study aims to correlate these biomarkers with the Galloway score, a measure of kidney health, to enhance monitoring and management of renal function in this patient population.

Why it matters

Potential benefit: If successful, this study could lead to improved early detection of kidney damage in spina bifida patients, allowing for timely interventions.

How similar studies have gone: While the approach of using urinary biomarkers is promising, the specific application in spina bifida is novel and has not been extensively tested in prior studies.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Rennes University Hospital
    Rennes, CHU de Rennes, France
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.