Spina BifidaSPINLESSNCT06041334
Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up
A study testing Collection of a urine sample and Magnetic Resonance Imaging of the bladder in people with Spina Bifida, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Spina Bifida
- What is being tested?
- Collection of a urine sample and Magnetic Resonance Imaging of the bladder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jan 2024to 18 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Rennes University Hospital
Rennes, CHU de Rennes, 35033
Emmanuelle SAMSON, MD, 33299289763, emmanuelle.samson@chu-rennes.fr
Benoit Peyronnet, MD, Benoit.PEYRONNET@chu-rennes.fr
About this study
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
- Being tested
- Collection of a urine sample, Magnetic Resonance Imaging of the bladder
- Keywords
- Spina Bifida, urinary biomarker, upper urinary tract, Galloway score, urodynamic work-up, urethrocystography
- Medical subject headings
- Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of a urine sampleBiological
Collection of a urine sample for analysis of urinary biomarkers and urinary metabolomics (Inclusion and 1 year)
Magnetic Resonance Imaging of the bladderDiagnostic test
Magnetic Resonance Imaging of the bladder (10 adults patients only) (Inclusion and 1 year)
| Study group | Role | What they receive |
|---|---|---|
| Study volunteers | Other | Not described Receives: Biological: Collection of a urine sample; Diagnostic Test: Magnetic Resonance Imaging of the bladder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verify if levels of urinary biomarkers Metalloproteinase Inhibitor 2 and matrix metalloproteinase-2 are associated with Galloway score
Logistic regression based on composite analysis of Galloway score (≤ 5 (low risk) or >5 (high risk)) and the rate of urinary biomarkers.
Measured: 1 day
Secondary outcomes (7)
Galloway score
Change in Galloway score from baseline to 1 year based on change in urinary biomarkers Metalloproteinase Inhibitor 2 and matrix metalloproteinase-2
Measured: 1 year
Success or failure of treatment
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.
Measured: 1 year
Relationship between the success of the treatment implemented at inclusion and the level of urinary biomarkers
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.
Measured: 1 year
Bladder hypocompliance based on metabolomic profile at inclusion
Presence or absence of bladder hypocompliance on urodynamic assessment at baseline, based on metabolomic profile at baseline.
Measured: 0 day
Bladder hypocompliance based on MRI radiomic markers at inclusion
Presence or absence of bladder hypocompliance on the urodynamic work-up at inclusion, based on MRI radiomic markers at inclusion.
Measured: 0 day
Bladder hypocompliance based on MRI radiomic markers at 1 year
Presence or absence of bladder hypocompliance on urodynamic assessment at 1 year according to MRI radiomic markers at 1 year
Measured: 1 year
Presence of biomarkers on bladder histological specimens
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.
Measured: From enrollment to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start18 Jan 2024
- Primary completion18 Jul 2027 (estimated)
- Study completion18 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spina BifidaStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroSphinx
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041334
- Sponsor's protocol ID
- 35RC20_9746_SPINLESS
- Other IDs
- IDRCB
- Acronym
- SPINLESS
- Status last verified
- Dec 2025
- First submitted
- 7 Sep 2023
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up
- ClinicalTrials.gov ID
- NCT06041334
- Acronym / sponsor ID
- SPINLESS / 35RC20_9746_SPINLESS
- Conditions
- Spina Bifida
- Keywords
- Spina Bifida, urinary biomarker, upper urinary tract, Galloway score, urodynamic work-up, urethrocystography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- NeuroSphinx
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 18 Jul 2027 (estimated)
- Study completion
- 18 Jul 2028 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study volunteers | Other | Biological: Collection of a urine sample, Diagnostic Test: Magnetic Resonance Imaging of the bladder |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of a urine sampleCollection of a urine sample for analysis of urinary biomarkers and urinary metabolomics (Inclusion and 1 year) | Biological | Study volunteers |
| Magnetic Resonance Imaging of the bladderMagnetic Resonance Imaging of the bladder (10 adults patients only) (Inclusion and 1 year) | Diagnostic test | Study volunteers |
Primary outcome
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.
7 secondary outcomes
Galloway score
Time frame: 1 year
Success or failure of treatment
Time frame: 1 year
Relationship between the success of the treatment implemented at inclusion and the level of urinary biomarkers
Time frame: 1 year
Bladder hypocompliance based on metabolomic profile at inclusion
Time frame: 0 day
Bladder hypocompliance based on MRI radiomic markers at inclusion
Time frame: 0 day
Bladder hypocompliance based on MRI radiomic markers at 1 year
Time frame: 1 year
Presence of biomarkers on bladder histological specimens
Time frame: From enrollment to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of a urine sample and Magnetic Resonance Imaging of the bladder in people with Spina Bifida, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LOÏC JACOB (0299282555, loic.jacob@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verify if levels of urinary biomarkers Metalloproteinase Inhibitor 2 and matrix metalloproteinase-2 are associated with Galloway score (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.