Botulinum Toxin A vs Anticholinergic Treatment of Neurogenic Overactive Bladder in Patients With … (NCT04819360) | Clinical Trial Compass
TerminatedPhase 4
Botulinum Toxin A vs Anticholinergic Treatment of Neurogenic Overactive Bladder in Patients With Multiple Sclerosis
Stopped: Lack of recruitment
Switzerland1 participantsStarted 2021-06-01
Plain-language 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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 substanc…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Magnitude of effect - Number of micturitions per 24h