Botulinum Toxin A vs Anticholinergic Treatment of Neurogenic Overactive Bladder in Patients With Multiple Sclerosis

• Status: Not yet recruiting
• Trial end date: 2023-01-31
• Target enrollment: 0
• Participant gender: All

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. Anticholinergics are established as the usual first-line treatment for neurogenic detrusor hyperactivity, but are oft not sufficiently effective and have significant side effects. In patients with multiple sclerosis (MS) suffering from overactive bladder, the 200 U dose of BOTOX® is very effective but induces a risk of urinary retention in 30% of patients requiring the temporary use of self-catheterization1. At 100 U, a recent study shows the efficacy and very good tolerance of botulinum toxin A in terms of probing risk in MS patients with overactive bladder and failure of anticholinergics. Furthermore, the efficacy of anticholinergics in MS has been little studied and is also disputed.

The investigators plan to test the therapeutic alternative as the first line of treatment in two groups of randomized MS patients from a homogeneous population suffering from overactive bladder:

• a group testing the effectiveness of low doses of botulinum toxin type A (100 U, BOTOX®),

• the other group receiving the standard anticholinergic treatment (solifenacin succinate, Vesicare®).

During this pilot study, the efficacy and side effects profile of each treatment will be analyzed in order to determine the amplitudes of effect and the safety profiles in this population and in order to establish the statistical hypotheses for a subsequent randomized multicenter study. The aim of this study will be to establish the benefit of botulinum toxin at a dose of 100 U as a first-line treatment instead of anticholinergics

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigitte Schürch
• Collaborator: Centre Hospitalier Universitaire Vaudois
• Treatments: Botulinum Toxins, Type A; Solifenacin Succinate

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