Multiple SclerosisSEP-1NCT06161376
Role of Urinary Sphingosine 1-Phosphate as a Biomarker for Detrusor Hyperactivity in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by University Hospital, Toulouse at 1 site in France.
Trial summary
This study aims to establish a link between urinary Sphingosine 1-Phosphate (S1P) levels and detrusor activity in multiple sclerosis (MS) patients. MS often involves urological symptoms, primarily overactive bladder. The gold standard for evaluation and treatment monitoring is invasive urodynamic testing. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- S1P level
- Type of treatment
- Injection or infusion
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2023to Dec 2027
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients diagnosed with multiple sclerosis
Who may be able to join
- French residents enrolled in the social security system
- Patients diagnosed with multiple sclerosis (according to McDonald 2017 criteria), whether receiving treatment or not
- Patients scheduled for urodynamic assessment as part of their management
Who cannot join
- Pregnant or lactating females
- Patients under legal guardianship
- Untreated urinary tract infection at the time of inclusion
- Known anatomical subvesical obstruction Known pelvic floor disorder Urothelial carcinoma Interstitial cystitis Augmentation cystoplasty
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
Toulouse Hospital
Toulouse
Xavier GAME, 0561778490, game.x@chu-toulouse.fr
About this study
Official title: Prospective Study Evaluating the Role of Urinary Sphingosine 1-Phosphate as a Biomarker for Detrusor Hyperactivity in Multiple Sclerosis
This study aims to establish a link between urinary Sphingosine 1-Phosphate (S1P) levels and detrusor activity in multiple sclerosis (MS) patients. MS often involves urological symptoms, primarily overactive bladder. The gold standard for evaluation and treatment monitoring is invasive urodynamic testing. Preliminary research at Toulouse University Hospital suggests urinary S1P levels may be a potential biomarker for detrusor activity in MS. This study aims to confirm this potential biomarker's utility.
- Conditions
- Multiple Sclerosis
- Being tested
- S1P level
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S1P levelOther
Patients will undergo urinary S1P level assessments before treatment, 6 weeks post-injection, and following any symptomatic changes that may lead to another urodynamic assessments.
| Study group | Role | What they receive |
|---|---|---|
| multiple sclerosis | Patients diagnosed with MS requiring urodynamic assessment will be recruited during outpatient visits at Toulouse University Hospital. Initial consultations will involve questionnaire completion, 72-hour voiding diaries, and urine sample collection just before urodynamic assessments. Receives: Other: S1P level |
What is being measured
The primary outcome is the main question the study is designed to answer.
S1P concentration
To compare of the urinary concentration of S1P related to creatinine in urine sample, as a function of the detrusor activity determined at BUD, before and after a first intra-detrusor injection of botulinum toxin.
Measured: Day 0, after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start4 Dec 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Game, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161376
- Sponsor's protocol ID
- RC31/23/0346
- Acronym
- SEP-1
- Status last verified
- Dec 2025
- First submitted
- 29 Nov 2023
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Evaluating the Role of Urinary Sphingosine 1-Phosphate as a Biomarker for Detrusor Hyperactivity in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06161376
- Acronym / sponsor ID
- SEP-1 / RC31/23/0346
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Dec 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.
This study aims to establish a link between urinary Sphingosine 1-Phosphate (S1P) levels and detrusor activity in multiple sclerosis (MS) patients. MS often involves urological symptoms, primarily overactive bladder. The gold standard for evaluation and treatment monitoring is invasive urodynamic testing. Preliminary research at Toulouse University Hospital suggests urinary S1P levels may be a potential biomarker for detrusor activity in MS. This study aims to confirm this potential biomarker's utility.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| multiple sclerosis | – | Other: S1P levelPatients diagnosed with MS requiring urodynamic assessment will be recruited during outpatient visits at Toulouse University Hospital. Initial consultations will involve questionnaire completion, 72-hour voiding diaries, and urine sample collection just before urodynamic assessments. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with multiple sclerosis
Key inclusion criteria (3 listed)
- French residents enrolled in the social security system
- Patients diagnosed with multiple sclerosis (according to McDonald 2017 criteria), whether receiving treatment or not
- Patients scheduled for urodynamic assessment as part of their management
Key exclusion criteria (4 listed)
- Pregnant or lactating females
- Patients under legal guardianship
- Untreated urinary tract infection at the time of inclusion
- Known anatomical subvesical obstruction Known pelvic floor disorder Urothelial carcinoma Interstitial cystitis Augmentation cystoplasty
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 |
|---|---|---|
| S1P levelPatients will undergo urinary S1P level assessments before treatment, 6 weeks post-injection, and following any symptomatic changes that may lead to another urodynamic assessments. | Other | multiple sclerosis |
Primary outcome
S1P concentration
Time frame: Day 0, after 6 months
To compare of the urinary concentration of S1P related to creatinine in urine sample, as a function of the detrusor activity determined at BUD, before and after a first intra-detrusor injection of botulinum toxin.
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 31 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Xavier Game, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University Hospital, Toulouse 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 4 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 31 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 Xavier Game, MD (05 61 32 33 01, game.x@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
S1P concentration (time frame: Day 0, after 6 months). 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 31 Dec 2025.