Efficacy of Alpha-blockers (Tamsulosin) in the Treatment of Symptomatic Dysuria in Multiple Sclerosis in Women

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Jun 27, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called tamsulosin in treating urinary symptoms like painful urination, or dysuria, in women with multiple sclerosis (MS). Multiple sclerosis can cause various bladder issues that significantly impact daily life and health. Tamsulosin is an alpha-blocker that helps relax certain muscles in the urinary tract, making it easier to urinate and potentially improving symptoms.

To participate in this study, women need to be diagnosed with MS and have moderate to severe dysuria. They must also be stable on their current treatments and be able to provide informed consent. Participants will take tamsulosin daily and will be monitored for improvements in their urinary symptoms and overall quality of life. This trial is currently recruiting, and if you or someone you know fits the eligibility criteria, it could be an opportunity to contribute to important research while potentially finding relief from bothersome symptoms.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.