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

Multiple Sclerosis Clinical Trial

— SEP-1  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06161376
• Other study ID #: RC31/23/0346
• Status: Not yet recruiting
• Start date: December 2023
• Est. completion date: December 2027

Study information

• Verified date: November 2023
• Source: University Hospital, Toulouse
• Contact: Xavier Game, MD
• Phone: 05 61 32 33 01
• Email: game.x[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• S1P level
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0, after 6 months