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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT04819360
Eligibility Criteria:
Inclusion Criteria:
* Patients with multiple sclerosis (MS) with neurogenic detrusor overactivity proven by urodynamics
* Stable MS with an Expanded Disability Severity Score (EDSS) less than or equal to 6.5
* Voluntary micturitions
* Number of micturitions \> 8 per day, with or without episodes of urgency and urgency incontinence
* Signed informed consent form
Exclusion Criteria:
* Pregnancy, breastfeeding
* Patients requiring self-catheterizations
* Patients unable or unwilling to learn self-catheterisation
* Recent (\<12 weeks) or current treatment with botulinum toxin for any non-urological indication
* Recent (≤ 8 weeks) or current treatment with anticholinergic drugs
* Patients with a positive history or evidence of pelvic / urological abnormality (interstitial cystitis, bladder lithiasis in the 6 months preceding the screening, or any other condition / operation affecting the bladder or prostate)
* Any contraindication to Vesicare®:
* Hypersensitivity to the active ingredient or to one of the excipients
* Urinary retention
* Untreated narrow-angle glaucoma
* Severe gastrointestinal illness (e.g. toxic megacolon)
* Myasthenia gravis
* Severe hepatic failure
* Hemodialysis
* Severe renal failure, or liver function disturbances of moderate severity with concomitant treatment with a strong inhibitor of the CYP3A4 isoenzyme, including patients at risk for these diseases.
* Any contraindication to BOTOX®:
* Known hypersensitivity to the active substance or to one of the excipients
* Presence of a symptomatic infection at the planned injection site(s)
* Urinary tract infection at the time of planned treatment
* Patients who present with acute urinary retention at the time of treatment and who do not regularly use bladder catheterization
* Patients who do not want and / or cannot, if necessary, perform self-intermittent catheterisation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04819360
Study Brief:
Protocol Section:
NCT04819360