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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Multiple sclerosis (MS) is a leading cause of severe disability in young people, often causing relapses that affect neurological functions. Many patients with MS experience bladder and bowel disorders, including dysuria, which can lead to urinary tract infections, kidney problems, and a lowered quality of life. This study is evaluating the use of alpha-blockers, specifically tamsulosin, to improve urinary symptoms in women with MS who have symptomatic dysuria. Participants in this trial will be randomly assigned to receive either a daily 0.4 mg capsule of tamsulosin or a placebo capsule for 30 days. The study uses a triple-blind design to compare the effects of tamsulosin against placebo. The treatment aims to reduce post-void residual urine, improve urine flow, and enhance quality of life by relaxing muscles involved in bladder emptying. During the 90-day study period, participants will undergo several assessments at the start and end of the intervention phase, including evaluations of urinary symptoms, post-void residual volume, maximum urine flow rate, fatigue, and quality of life. Safety of the drug will also be monitored. These measures will help researchers understand the potential benefits and risks of tamsulosin for treating dysuria in women with MS.
CONDITIONS
Brief 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 has given free and informed consent and signed the consent form
- The patient is a member or beneficiary of a health insurance plan
- Patient has multiple sclerosis with an EDSS score less than 7.5
- Moderate to severe dysuria (IPSS score greater than 7) due to bladder sphincter dyssynergia confirmed by complete urodynamic workup
- Patient is under stable treatment
You will not qualify if you...
- Participation in another category 1 interventional study or a trial involving a non-CE marked or off-label medical device, or within an exclusion period from a previous study
- Refusal to sign the consent form
- Inability to provide informed information
- Under safeguard of justice or state guardianship
- Hypersensitivity to tamsulosin 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 an indwelling bladder catheter
- Major medical or psychiatric illness that may risk safety or compliance
- Presence of another neurological disease other than MS
- Swallowing problems affecting oral medication
- Scheduled cataract surgery within 4 months
- Pregnant, in labor, or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 30 days per intervention phase
Participants receive either one 0.4mg Tamsulosin capsule or a placebo capsule daily for 30 days during each intervention phase.
2 visits per phase (start and end of 30-day treatment)
Duration - 30 days per intervention phase
Participants cross over to the alternate treatment (Tamsulosin or placebo) for another 30 days.
2 visits per phase (start and end of 30-day treatment)
Trial Site Locations
Total: 1 location
1
CHU de Nîmes
Nîmes, France
Actively Recruiting
Research Team
S
Stéphane DROUPY
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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