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NCT Number: NCT06041334

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

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.

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Key information

Conditions

Spina Bifida Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Nervous System Diseases Nervous System Malformations Neural Tube Defects Spinal Dysraphism

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rennes University Hospital

Rennes, CHU de Rennes, 35033, France

Location status: Recruiting

Location contact

Benoit Peyronnet, MD

CONTACT

[email protected]

Emmanuelle SAMSON, MD

CONTACT

[email protected]

33299289763

Emmanuelle SAMSON, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of a urine sample

Biological

Collection of a urine sample for analysis of urinary biomarkers and urinary metabolomics (Inclusion and 1 year)

Magnetic Resonance Imaging of the bladder

Diagnostic Test

Magnetic Resonance Imaging of the bladder (10 adults patients only) (Inclusion and 1 year)

Primary outcomes

  1. Verify if levels of urinary biomarkers Metalloproteinase Inhibitor 2 and matrix metalloproteinase-2 are associated with Galloway score

    Time frame: 1 day

    Logistic regression based on composite analysis of Galloway score (≤ 5 (low risk) or >5 (high risk)) and the rate of urinary biomarkers.

Secondary outcomes

  1. Galloway score

    Time frame: 1 year

    Change in Galloway score from baseline to 1 year based on change in urinary biomarkers Metalloproteinase Inhibitor 2 and matrix metalloproteinase-2

  2. Success or failure of treatment

    Time frame: 1 year

    The success of the treatment will be assessed at 1 year after its implementation according to an hybrid criteria : In the event of a Patients Global Impression of Improvement for Incontinence questionnaire < 3 and/or a Galloway score reduction of 1 or 2, the treatment will be considered successful.

  3. Relationship between the success of the treatment implemented at inclusion and the level of urinary biomarkers

    Time frame: 1 year

    The relationship between the success of the treatment implemented at inclusion and the level of the urinary biomarkers Metalloproteinase Inhibitor 2 Anticorps and matrix metalloproteinase-2 at inclusion will be studied.

  4. Bladder hypocompliance based on metabolomic profile at inclusion

    Time frame: 0 day

    Presence or absence of bladder hypocompliance on urodynamic assessment at baseline, based on metabolomic profile at baseline.

  5. Bladder hypocompliance based on MRI radiomic markers at inclusion

    Time frame: 0 day

    Presence or absence of bladder hypocompliance on the urodynamic work-up at inclusion, based on MRI radiomic markers at inclusion.

  6. Bladder hypocompliance based on MRI radiomic markers at 1 year

    Time frame: 1 year

    Presence or absence of bladder hypocompliance on urodynamic assessment at 1 year according to MRI radiomic markers at 1 year

  7. Presence of biomarkers on bladder histological specimens

    Time frame: From enrollment to 1 year

    Presence of Metalloproteinase Inhibitor 2 Anticorps and matrix metalloproteinase-2 biomarkers on bladder histological specimens based on levels of urinary Metalloproteinase Inhibitor 2 Anticorps and matrix metalloproteinase-2 biomarkers respectively.

Study contacts

Contact information is provided by the study sponsor or research team.

LOÏC JACOB

CONTACT

[email protected]

0299282555

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • NeuroSphinx

Registry information

Acronym: SPINLESS

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Sep 18, 2023
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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