RecruitingNot ApplicableNCT05439902

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


Sponsor

Centre Hospitalier Universitaire de Nīmes

Enrollment

60 participants

Start Date

Oct 5, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether tamsulosin — a medication usually used for prostate problems — can help women with multiple sclerosis (MS) who have difficulty urinating due to a bladder coordination problem called bladder sphincter dyssynergia. This condition makes it hard for the bladder and its outlet valve to work together properly. **You may be eligible if:** - You are a woman with multiple sclerosis (EDSS score below 7.5, meaning you can still walk with assistance) - You have moderate to severe urinary difficulties confirmed by a bladder function test (urodynamic workup) - You are on stable treatment for your MS **You may NOT be eligible if:** - You are already participating in another interventional clinical study - You are unable or unwilling to provide consent - You are under legal guardianship or safeguard of justice Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTamsulosin

One 0.4mg Tamsulosin capsule taken per day for 30 days

DRUGPlacebo

one placebo capsule per day for 30 days. with identical appearance (color and size) to the experimental drug, composed of microcrystalline cellulose


Locations(1)

CHU de Nîmes

Nîmes, France

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NCT05439902


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