Using Tamsulosin to Treat Urinary Symptoms in Women with Multiple Sclerosis

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

This study is testing if the medication Tamsulosin can help women with multiple sclerosis who have trouble urinating feel better and improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Centre Hospitalier Universitaire de Nīmes (Academic / other)
• Locations: 1 site (Nîmes)
• Trial ID: NCT05439902 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy of Tamsulosin, an alpha-blocker, in treating symptomatic dysuria in women diagnosed with multiple sclerosis. The study focuses on patients experiencing moderate to severe dysuria due to bladder sphincter dyssynergia, confirmed through urodynamic testing. Participants will be randomly assigned to receive either Tamsulosin or a placebo, with the aim of assessing improvements in urinary symptoms and overall quality of life. The trial seeks to address a significant issue faced by many MS patients, as lower urinary tract dysfunction can lead to serious health complications.

Who should consider this trial

Good fit: Ideal candidates are women with multiple sclerosis experiencing moderate to severe dysuria and a confirmed diagnosis of bladder sphincter dyssynergia.

Not a fit: Patients with severe hepatic impairment or those who are hypersensitive to Tamsulosin will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve urinary symptoms and quality of life for women with multiple sclerosis.

How similar studies have performed: While the use of alpha-blockers for urinary symptoms in MS is not extensively studied, similar approaches have shown promise in managing lower urinary tract symptoms in other populations.

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.

Where this trial is running

Nîmes

• CHU de Nîmes — Nîmes, France (Recruiting)

Study contacts

• Principal investigator: Stéphane DROUPY — CHU de Nimes
• Study coordinator: Stéphane DROUPY

Conditions Multiple Sclerosis; Dysuria; Lower Urinary Tract Symptoms; Voiding Dysfunction; Urinary Retention