Status:
TERMINATED
Botulinum Toxin a Vs Anticholinergic Treatment of Neurogenic Overactive Bladder in Patients with Multiple Sclerosis
Lead Sponsor:
Brigitte Schürch
Collaborating Sponsors:
Centre Hospitalier Universitaire Vaudois
Conditions:
Urinary Bladder, Neurogenic
Multiple Sclerosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Botulinum toxin type A injections into the detrusor at a dose of 200 units (U) of BOTOX® are a recognized second-line treatment for the treatment of adult neurogenic lower urinary tract disorders. Ant...
Detailed Description
Botulinum toxin type A (BOTOX®) injections will performed on an outpatient basis by cystoscopy under local anesthesia. Twenty minutes after an intravesical instillation of 20 ml of 0.2% ropivacaine, t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2024
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04819360
Start Date
June 1 2021
End Date
April 21 2024
Last Update
September 27 2024
Active Locations (1)
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1
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011