Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT05439902
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* The subject is participating in another category 1 interventional study, or a trial involving a non-CE marked or CE marked off-label medical device or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Hypersensitivity to tamsulosin hydrochloride, including angioedema induced by the drug or any of the excipients.
* History of orthostatic hypotension.
* Severe hepatic impairment.
* Concomitant treatment with diclofenac, warfarin, CYP3A4 inhibitors.
* \- Patient with complete urinary retention at the time of the pre-inclusion consultation, requiring management by intermittent self-catheterization or, failing that, an indwelling bladder catheter from the outset.
* Major medical or psychiatric illness that, in the opinion of the investigator, would place the subject at risk or could compromise compliance with the study protocol.
* Presence of another neurological pathology (excluding MS).
* Swallowing problems that compromise oral medication.
* Scheduled cataract surgery within 4 months.
* Pregnant, parturient or breastfeeding patient.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05439902
Study Brief:
Protocol Section:
NCT05439902