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

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis; Dysuria; Lower Urinary Tract Symptoms; Voiding Dysfunction; Urinary Retention
• Interventions: Drug: Placebo; Drug: Tamsulosin

• Registration Number: NCT05439902
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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 the location of the new inflammatory lesion(s). The disease can thus manifest itself through bladder and bowel disorders (BWS), which affect approximately 80% of MS patients in all stages. Lower urinary tract dysfunction has a significant negative impact on the quality of life of patients and places a significant burden on the healthcare system in terms of resource allocation. In addition, there is a risk of long-term chronic renal failure, an infectious risk (recurrent cystitis and/or pyelonephritis, sometimes life-threatening) and a lithiasis risk.

The most frequently observed urinary symptoms are: urinary frequency, urgency with or without urinary incontinence, dysuria and chronic retention of urine. These disorders most often combine bladder hyperactivity and dysuria. This dysuria may be responsible for recurrent urinary tract infections, lithiasis, alteration of renal function.

The only therapeutic class currently used to treat dysuria in MS is alpha-blockers. Tamsulosin, alfusozin and doxazosin induce relaxation of the urethral smooth sphincter and prostatic urethral muscle fibers, facilitating the removal of subvesical obstruction and bladder emptying.

The study investigators hypothesize that treatment with tamsulosin 0.4 mg daily in adult MS patients with dysuria will result in symptom improvement as assessed by the International Prostate Symptom Score (IPSS) and Urinary Symptom Profile (USP) scores, a decrease in post-void residual, and an improvement in urine flow and quality of life.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-06-27
• Study First Posted: 2022-06-30
• Study Start: 2022-10-05
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-25
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Tamsulosin	Tamsulosin	-

Primary Outcome Measures

Name	Time	Method
Urinary symptoms between groups	End of first intervention phase (Day 90)	Measured using the International Prostate Symptom Scale (IPSS), scoring ranging from 0-35

Secondary Outcome Measures

Name	Time	Method
Maximum urine flow rate between groups	End of first intervention phase (Day 90)	ml/s
Quality of life linked to urinary dysfunction between groups	End of first intervention phase (Day 90)	Qualiveen-30 questionnaire; score 0-4
Quality of life between groups	End of first intervention phase (Day 90)	EQ-5D questionnaire; score 0-100
Urinary symptoms between groups	End of first intervention phase (Day 90)	Measured using the Urinary Symptom Profile (USP) questionnaire: score ranging from 0-39
Post-mictional residue between groups	End of first intervention phase (Day 90)	ml, measured with BladderScan
Fatigue between groups	End of first intervention phase (Day 90)	Modified Fatigue Impact Scale; score 0-84
Drug safety	End of first intervention phase (Day 90)	Yes/no occurence of the following adverse events: headache, asthenia, gastrointestinal disorders, orthostatic hypotension

Trial Locations

Locations (1)

CHU de Nîmes; 🇫🇷 Nîmes, France