Actively Recruiting
Efficacy of Alpha-blockers (Tamsulosin) in the Treatment of Symptomatic Dysuria in Multiple Sclerosis in Women
Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2024-06-25
60
Participants Needed
1
Research Sites
177 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Alpha-blockers (Tamsulosin) in the Treatment of Symptomatic Dysuria in Multiple Sclerosis in Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Participation in another category 1 interventional study or trial involving non-CE marked or CE marked off-label medical devices or within exclusion period from previous study
- Refusal to sign the consent form
- Inability to provide informed information
- Under safeguard of justice or state guardianship
- Hypersensitivity to tamsulosin hydrochloride or its excipients including angioedema
- History of orthostatic hypotension
- Severe hepatic impairment
- Concomitant treatment with diclofenac, warfarin, or CYP3A4 inhibitors
- Complete urinary retention requiring intermittent self-catheterization or indwelling bladder catheter at pre-inclusion
- Major medical or psychiatric illness risking participant safety or study compliance
- Presence of another neurological disease excluding MS
- Swallowing problems affecting oral medication intake
- Scheduled cataract surgery within 4 months
- Pregnant, parturient, or breastfeeding patient
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU de Nîmes
Nîmes, France
Actively Recruiting
Research Team
S
Stéphane DROUPY
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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