Status:
RECRUITING
Efficacy of Alpha-blockers (Tamsulosin) in the Treatment of Symptomatic Dysuria in Multiple Sclerosis in Women
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Conditions:
Multiple Sclerosis
Dysuria
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Multiple sclerosis (MS) is the leading non-traumatic cause of severe acquired disability in young people. The disease is defined by relapses, which can affect all neurological functions depending on t...
Eligibility Criteria
Inclusion
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- Patient with multiple sclerosis (EDSS score \< 7.5).
- Moderate to severe dysuria (IPSS score \> 7) due to bladder sphincter dyssynergia confirmed by complete urodynamic workup.
- Patient under stable treatment.
Exclusion
- The subject is participating in another category 1 interventional study, or a trial involving a non-CE marked or CE marked off-label medical device or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Hypersensitivity to tamsulosin hydrochloride, including angioedema induced by the drug or any of the excipients.
- History of orthostatic hypotension.
- Severe hepatic impairment.
- Concomitant treatment with diclofenac, warfarin, CYP3A4 inhibitors.
- \- Patient with complete urinary retention at the time of the pre-inclusion consultation, requiring management by intermittent self-catheterization or, failing that, an indwelling bladder catheter from the outset.
- Major medical or psychiatric illness that, in the opinion of the investigator, would place the subject at risk or could compromise compliance with the study protocol.
- Presence of another neurological pathology (excluding MS).
- Swallowing problems that compromise oral medication.
- Scheduled cataract surgery within 4 months.
- Pregnant, parturient or breastfeeding patient.
Key Trial Info
Start Date :
October 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05439902
Start Date
October 5 2022
End Date
March 1 2026
Last Update
June 25 2024
Active Locations (1)
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1
CHU de Nîmes
Nîmes, France