Multiple Sclerosis Clinical Trial
— SEPTOXOfficial title:
Injections of Botulinum Toxin A or Anticholinergic Treatment as First Line Therapy to Treat Neurogenic Overactive Bladder in Patients With Multiple Sclerosis
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
Status | Recruiting |
Enrollment | 46 |
Est. completion date | January 31, 2023 |
Est. primary completion date | November 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Centre Hospitalier Universitaire Vaudois | Lausanne |
Lead Sponsor | Collaborator |
---|---|
Brigitte Schürch | Centre Hospitalier Universitaire Vaudois |
Switzerland,
Chermansky C, Schurch B, Rahnama'i MS, Averbeck MA, Malde S, Mancini V, Valentini F, Sahai A. How can we better manage drug-resistant OAB/DO? ICI-RS 2018. Neurourol Urodyn. 2019 Dec;38 Suppl 5:S46-S55. doi: 10.1002/nau.24055. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patients reported outcomes - Patients' satisfaction | Patients' satisfaction, measured by the Patient Global Impression of Improvement (PGI-I), at 2, 6 and 12 weeks after the start of the treatment, as compared to inclusion values. | 2, 6 and 12 weeks | |
Other | Patients reported outcomes - Patients' specific quality of life | Patients' specific quality of life, measured by the Urinary Incontinence Quality of Life Scale (I-QOL), at 2, 6 and 12 weeks after the start of the treatment, as compared to inclusion values. | 2, 6 and 12 weeks | |
Other | Patients reported outcomes - Subjective improvement | Patients' subjective improvement, measured by a Visual Analog Scale (VAS), at 2, 6 and 12 weeks after the start of the treatment, as compared to inclusion values. | 2, 6 and 12 weeks | |
Other | Security - Self-catheterizations | Need for self-catheterizations according to pre-specified criteria, at any time during the trial | Any time during the 12 weeks of the trial | |
Other | Security - Urinary tract infections | Number of urinary tract infections episodes, at any time during the trial | Any time during the 12 weeks of the trial | |
Other | Security - Adverse drug reactions due to anticholinergic drugs | Number of adverse drug reactions due to anticholinergic drugs, at any time during the trial | Any time during the 12 weeks of the trial | |
Other | Security - Adverse drug reactions due to Botox | Number of adverse drug reactions due to Botox, at any time during the trial | Any time during the 12 weeks of the trial | |
Primary | Magnitude of effect - Number of micturitions per 24h | The difference in mean values of [the number of micturitions / 24 h for the last 3 days] at T0 (inclusion) and T6W (6 weeks after start of the treatment). | 6 weeks | |
Secondary | Other parameters of effects - Number of urgent urinations per 24h | The difference in mean values of [the number of episodes of urgent urination / 24 h for the last 3 days] at T0 (inclusion) and T2W (2 weeks after start of the treatment).
The difference in mean values of [the number of episodes of urgent urination / 24 h for the last 3 days] at T0 (inclusion) and T6W (6 weeks after start of the treatment). The difference in mean values of [the number of episodes of urgent urination / 24 h for the last 3 days] at T0 (inclusion) and T12W (12 weeks after start of the treatment). |
2, 6 and 12 weeks after treatment start | |
Secondary | Other parameters of effects - Number of urgency urinary incontinence episodes per 24h | The difference in mean values of [the number of urgency urinary incontinence episodes / 24 h for the last 3 days] at T0 (inclusion) and T2W (2 weeks after start of the treatment).
The difference in mean values of [the number of urgency urinary incontinence episodes / 24 h for the last 3 days] at T0 (inclusion) and T6W (6 weeks after start of the treatment). The difference in mean values of [the number of urgency urinary incontinence episodes / 24 h for the last 3 days] at T0 (inclusion) and T12W (12 weeks after start of the treatment). |
2, 6 and 12 weeks after treatment start | |
Secondary | Other parameters of effects - Number of nocturnal micturition episodes per 24h | The difference in mean values of [the number of nocturnal micturition episodes / 24 h for the last 3 days] at T0 (inclusion) and T2W (2 weeks after start of the treatment).
The difference in mean values of [the number of nocturnal micturition episodes / 24 h for the last 3 days] at T0 (inclusion) and T6W (6 weeks after start of the treatment). The difference in mean values of [the number of nocturnal micturition episodes / 24 h for the last 3 days] at T0 (inclusion) and T12W (12 weeks after start of the treatment). |
2, 6 and 12 weeks after treatment start | |
Secondary | Other parameters of effects - Number of 100% dry patients | The difference in mean values of [the number of 100% dry patients / 24 h for the last 3 days] at T0 (inclusion) and T6W (6 weeks after start of the treatment).
The difference in mean values of [the number of 100% dry patients / 24 h for the last 3 days] at T0 (inclusion) and T12W (12 weeks after start of the treatment). |
6 and 12 weeks after treatment start | |
Secondary | Other parameters of effects - Urodynamic parameter : cystomanometric capacity | The difference in cystomanometric capacity at 6 weeks after the start of the treatment, as compared to inclusion values. | 6 weeks after treatment start | |
Secondary | Other parameters of effects - Urodynamic parameter : reflex volume at first contraction | The difference in reflex volume at first contraction at 6 weeks after the start of the treatment, as compared to inclusion values. | 6 weeks after treatment start | |
Secondary | Other parameters of effects - Urodynamic parameter : bladder compliance | Bladder compliance describes the relationship between change in bladder volume (?V) and change in detrusor pressure (?pdet).
Compliance is calculated by dividing the volume change (?V) by the change in detrusor pressure (?pdet) during that change in bladder volume (C= ?V/?pdet). It is expressed in ml/cm H2O. |
6 weeks after treatment start | |
Secondary | Other parameters of effects - Urodynamic parameter : maximum detrusor pressure | The difference in maximum detrusor pressure at 6 weeks after the start of the treatment, as compared to inclusion values. | 6 weeks after treatment start | |
Secondary | Other parameters of effects - Urodynamic parameter : post-void residual after flowmetry | The difference in post-void residual after flowmetry at 6 weeks after the start of the treatment, as compared to inclusion values. | 6 weeks after treatment start |
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