Evaluation de l’efficacité des alpha-bloquants (Tamsulosine) dans le traitement de la dysurie symptomatique de la sclérose en plaques chez la femme – Etude contrôlée randomisée en cross-over contre placebo.
This study is investigating if a medication called tamsulosin can help women with multiple sclerosis (MS) who experience difficulty urinating. Many women with MS find it hard to empty their bladder properly, which can be uncomfortable and affect daily life. This research aims to see if tamsulosin can improve these symptoms over a one-month period. Participants will receive both the active medication and a dummy pill (placebo) at different times, so researchers can compare their effects carefully. They'll measure changes in symptoms and other bladder functions to understand how well the treatment works and if it's safe. This is an early stage study, helping us learn more about potential treatments for this common MS symptom.
At a glance
What is this study about?
Many women living with multiple sclerosis (MS) experience problems with their bladder, making it difficult to pass urine effectively. This can be due to a condition where the bladder muscle and the muscle that controls urine flow don't work together properly. This can lead to symptoms like feeling you haven't emptied your bladder fully, needing to go often, or having a weak stream. These issues can be uncomfortable and impact daily activities.
This study, called a 'Phase II' trial, is designed to see if a medication called tamsulosin could help these bladder symptoms in women with MS. Tamsulosin is a drug that helps relax muscles in the prostate and bladder neck, often used in men, but researchers want to see if it can also benefit women with these specific MS-related bladder problems. The goal is to find out if it's effective and safe before it could potentially be used more widely.
Participants in the study will try both the tamsulosin medication and a 'dummy' pill (called a placebo) at different times. This 'cross-over' design helps researchers compare the effects of the real drug against no active treatment, giving a clearer picture of how well tamsulosin works. Researchers will carefully check how much symptoms improve and look at other measures of bladder function over a one-month period.
Key takeaways
- This study is for women with MS who have trouble urinating.
- It tests a medication called tamsulosin against a dummy pill.
- The study measures changes in bladder symptoms and function over one month.
- You will receive both the active drug and the dummy pill at different times.
- Potential side effects include headaches, tiredness, stomach upset, or dizziness.
- You can stop participating at any time.
Who may be eligible?
This study is looking primarily for female volunteers. You need to be 18 years old or older to take part, with no upper age limit.
To be considered, you must have been diagnosed with multiple sclerosis (MS). Your MS symptoms should not be so severe that they significantly impact your daily activities, as measured by a specific health score (your doctor will understand what an EDSS score below 7.5 means).
Additionally, you must experience moderate to severe trouble urinating, which means you have noticeable difficulty emptying your bladder. Special tests have to confirm that this problem is due to your bladder and the surrounding muscles not working together correctly.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you a woman?
- Are you 18 years old or over?
- Do you have a diagnosis of Multiple Sclerosis (MS)?
- Do you experience moderate to severe difficulty when urinating?
- Have tests confirmed that your bladder and surrounding muscles aren't working together properly?
- Are your MS symptoms not severely impacting your daily life (EDSS score below 7.5)? (Your doctor can clarify this for you).
What does participation involve?
If you decide to take part, you will be in the study for a short period, likely around two months in total. During this time, you will receive two different treatments: the active study drug (tamsulosin) and a dummy pill (placebo). You won't know which one you're getting at any particular time, but you will receive both at different points.
Over the course of the study, you'll have several appointments. At these appointments, researchers will ask you to complete questionnaires about your bladder symptoms, such as how often you need to go and if you feel you empty your bladder completely. They will also measure how much urine is left in your bladder after you go to the toilet using a special scanner, and check your urine flow rate. Your general health and quality of life will also be assessed. Researchers will monitor you for any side effects like headaches, tiredness, upset stomach, or dizziness when standing up. The main part of the treatment sequence will last one month.
Potential risks and benefits
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Common questions
What is tamsulosin?
Tamsulosin is a medicine that helps relax certain muscles, and this study aims to see if it can help women with MS who have difficulty urinating.
What is a 'dummy pill'?
A dummy pill, or placebo, looks just like the real medicine but contains no active drug. It helps researchers compare the effects of the actual treatment.
How long will the study last for me?
The main treatment period for each participant is one month, but the total time you are involved, including assessments, will likely be around two months.
Will I know if I'm getting the real drug or the dummy pill?
No, you won't know which one you're receiving at any given time. This is called 'blinding' and helps ensure the study results are accurate.
What kind of bladder problems are they looking at?
They're focusing on difficulty urinating (dysuria) due to the bladder and the muscle that controls urine flow not working together properly, which is common in MS.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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