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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Toulouse Hospital

Toulouse, France

Location status: Recruiting

Location contact

Xavier GAME

CONTACT

[email protected]

0561778490

Who can participate

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

S1P level

Other

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.

Primary outcomes

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.

Study contacts

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

Xavier Game, MD

CONTACT

[email protected]

05 61 32 33 01

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Prospective Study Evaluating the Role of Urinary Sphingosine 1-Phosphate as a Biomarker for Detrusor Hyperactivity in Multiple Sclerosis

Acronym: SEP-1

Important dates

Study start: 2023
Primary completion: 2027
Study completion: 2027
First posted: Dec 7, 2023
Registry last updated: Dec 31, 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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