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Study on the Effectiveness of Tamsulosin for Treating Urinary Symptoms in Women with Multiple Sclerosis

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What is this study about?

This clinical trial is focused on studying the effects of a medication called tamsulosin on women with Multiple Sclerosis who experience difficulty urinating, known as dysuria. Dysuria in this context is caused by a condition called vesico-sphincter dyssynergia, where the bladder and sphincter muscles do not work together properly. The study aims to evaluate how well tamsulosin can improve urinary symptoms in these patients.

Participants in the study will receive either tamsulosin or a placebo, which is a substance with no active medication. The study is designed to compare the effects of tamsulosin against the placebo over a period of one month. During this time, participants will be asked to complete a questionnaire called the International Prostate Symptom Scale (IPSS) to assess changes in their urinary symptoms. The study will also monitor other factors such as the amount of urine left in the bladder after urination, the maximum flow rate of urine, and any side effects like headaches or low blood pressure.

The goal of this research is to determine if tamsulosin can effectively reduce urinary symptoms in women with Multiple Sclerosis and dysuria. By participating in this study, researchers hope to gather valuable information that could lead to better treatment options for managing these symptoms in the future.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that the patient is an adult with multiple sclerosis and moderate to severe urination difficulties.

The assessment involves a complete urodynamic evaluation to confirm bladder and sphincter coordination issues.

2 treatment phase A

The patient begins the first treatment phase, which lasts for one month.

During this phase, the patient takes a capsule of Tamsulosin Gemax Pharma 0.4 mg orally each day. Tamsulosin is an alpha-blocker used to improve urination symptoms.

3 evaluation after phase A

At the end of the first month, the patient’s urinary symptoms are evaluated using the International Prostate Symptom Scale (IPSS) questionnaire.

Additional assessments include the Urinary Symptom Profile (USP) questionnaire, post-void residual volume measurement using BladderScan, and maximum urine flow rate using free uroflowmetry.

4 treatment phase B

The patient enters the second treatment phase, which also lasts for one month.

This phase may involve a placebo instead of the active medication, as the study is designed to compare the effects of Tamsulosin with a placebo.

5 evaluation after phase B

At the end of the second month, the same evaluations as in phase A are conducted to assess changes in urinary symptoms.

The occurrence of any side effects such as headaches, fatigue, gastrointestinal issues, or low blood pressure is also monitored.

6 final analysis

The study concludes with a final analysis of the data collected during both treatment phases.

The primary focus is on the change in IPSS scores, while secondary outcomes include changes in USP scores, post-void residual volume, maximum urine flow rate, and quality of life questionnaires.

Who Can Join the Study?

  • The patient must be an adult, which means they are 18 years or older.
  • The patient must have multiple sclerosis, a condition affecting the brain and spinal cord, with a disability score (EDSS) less than 7.5. This score measures how much the condition affects the patient’s daily life.
  • The patient must have moderate to severe difficulty urinating (dysuria), with a score greater than 7 on the IPSS. The IPSS is a questionnaire that helps measure urinary symptoms. This difficulty must be due to a problem with the bladder and sphincter muscles not working together properly, confirmed by a urodynamic test, which checks how well the bladder and urethra store and release urine.
  • The patient must be on a stable treatment, meaning their current medical treatment has not changed recently.
  • The patient must have given their informed consent, meaning they understand the study and agree to participate.
  • The patient must have signed the consent form, which is a document confirming their agreement to join the study.
  • The patient must be affiliated with or a beneficiary of a health insurance plan, meaning they have health insurance coverage.

Who Cannot Join the Study?

  • Patients who do not have multiple sclerosis. Multiple sclerosis is a condition that affects the brain and spinal cord.
  • Patients with an EDSS score of 7.5 or higher. The EDSS score is a way to measure how much multiple sclerosis affects a person, with higher scores indicating more severe disability.
  • Patients with mild dysuria. Dysuria means having difficulty or pain when urinating.
  • Patients with an IPSS score of 7 or lower. The IPSS score is a questionnaire used to measure urinary symptoms, with higher scores indicating more severe symptoms.
  • Patients without vesico-sphincter dyssynergia. This is a condition where the bladder and the muscle that controls urination do not work together properly.
  • Patients who have not had a complete urodynamic evaluation. This is a series of tests that check how well the bladder and urethra are storing and releasing urine.
  • Male patients. Only female patients are eligible for this study.
  • Patients under the age of 18 or over the age of 65.
  • Patients who are considered part of a vulnerable population. This means groups of people who might need special protection or care.

Where you can join this trial?

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Site Name City Country Status
Centre Hospitalier Universitaire De Nimes Nimes France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
05.10.2022

Trial locations

Investigated drugs:

Tamsulosin is a medication used in this clinical trial to help improve urinary symptoms in women with multiple sclerosis who experience difficulty urinating. It works by relaxing the muscles in the bladder and prostate, making it easier to urinate. The trial aims to evaluate how effective tamsulosin is in reducing urinary symptoms over a period of one month.

Investigated diseases:

Multiple Sclerosis – Multiple sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It is characterized by damage to the protective covering of nerve fibers, leading to communication problems between the brain and the rest of the body. Symptoms can vary widely and may include fatigue, difficulty walking, numbness, and muscle weakness. The disease often progresses with periods of relapses and remissions, where symptoms can worsen and then improve. Over time, some individuals may experience a gradual decline in function. The exact cause of multiple sclerosis is unknown, but it is believed to involve a combination of genetic and environmental factors.

Trial ID:
2024-516880-10-00
Protocol code:
NIMAO/2021-1/EB-01
Trial Phase:
Therapeutic exploratory (Phase II)

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