A Phase 4 interventional study of VESIcare 10Mg Tablet and Botox 100 UNT Injection in Urinary Bladder, Neurogenic and Multiple Sclerosis, sponsored by Brigitte Schürch. Terminated at 1 site in Switzerland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by Brigitte Schürch · Phase 4, Interventional, and Treatment
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:
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
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, the botulinum toxin is injected into the detrusor muscle using a flexible injection needle at a rate of 10 U of BOTOX® per mL (10 points of 1 mL injections). Intravenous prophylaxis (cefuroxime 1.5 g) will be performed 30 minutes before the injections.
Patients in the Vesicare® arm will be given the tablets at the baseline visit to be taken once a day in the morning for 12 weeks. For this arm, there will be no antibiotic prophylaxis.
Randomization will be carried out via eCRF in the secuTrial® environment with an integrated Interactive Web Response System (IWRS) function allowing the allocation of a participant to one of the two intervention groups. Randomization will be carried out using a randomization table in blocks of 2, predefined without the knowledge of the investigator, respecting a balanced allocation between the two groups, necessary given the modest number of participants in the study.
The intensity of therapeutic responses for each treatment is not precisely known in this patient population. As a result, there are no reliable preliminary data which would allow the investigators to calculate under these "effect size" assumptions the necessary numbers of participants to be randomized between the two intervention groups in order to demonstrate a possible superiority of treatment by injection of BOTOX® 100 U in comparison to the reference anticholinergic treatment. The comparative study will therefore only be accessible after determining the intensity of these effects.
Within the framework of a pilot study not directly comparative of the therapeutic approaches but seeking to identify the amplitude of the effects obtained independently by the two treatments, it does not appear necessary to resort to a study design with "double-dummy" to leave the patient blind to the method used. Such an approach would require the use of a sham injection by cystoscopic route in the group treated with anticholinergics and would not appear ethical in this context.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 1 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →This is the only study on the registry with Brigitte Schürch as lead sponsor.
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Exclusion Criteria:
Any contraindication to Vesicare®:
Any contraindication to BOTOX®:
Group 1: will be treated with an anticholinergic (Vesicare® 10 mg per day for 12 weeks)
Drug: VESIcare 10Mg Tablet
Group 2: will receive an intra-detrusor injection of a low dose of botulinum toxin type A (100 U of BOTOX®).
Drug: Botox 100 UNT Injection
Vesicare® 10 mg per day for 12 weeks Vesicare 10mg 12 weeks
Also known as: Vesicare
1 injection of Botox® 100 UNT
Also known as: Botox
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).
Time frame: 6 weeks
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).
Time frame: 2, 6 and 12 weeks after treatment start
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).
Time frame: 2, 6 and 12 weeks after treatment start
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).
Time frame: 2, 6 and 12 weeks after treatment start
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).
Time frame: 6 and 12 weeks after treatment start
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.
Time frame: 6 weeks after treatment start
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.
Time frame: 6 weeks after treatment start
Other parameters of effects - Urodynamic parameter : bladder compliance
Bladder compliance describes the relationship between change in bladder volume (ΔV) and change in detrusor pressure (Δpdet). Compliance is calculated by dividing the volume change (∆V) by the change in detrusor pressure (∆pdet) during that change in bladder volume (C= ΔV/∆pdet). It is expressed in ml/cm H2O.
Time frame: 6 weeks after treatment start
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.
Time frame: 6 weeks after treatment start
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.
Time frame: 6 weeks after treatment start
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.
Time frame: 2, 6 and 12 weeks
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.
Time frame: 2, 6 and 12 weeks
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.
Time frame: 2, 6 and 12 weeks
Security - Self-catheterizations
Need for self-catheterizations according to pre-specified criteria, at any time during the trial
Time frame: Any time during the 12 weeks of the trial
Security - Urinary tract infections
Number of urinary tract infections episodes, at any time during the trial
Time frame: Any time during the 12 weeks of the trial
Security - Adverse drug reactions due to anticholinergic drugs
Number of adverse drug reactions due to anticholinergic drugs, at any time during the trial
Time frame: Any time during the 12 weeks of the trial
Security - Adverse drug reactions due to Botox
Number of adverse drug reactions due to Botox, at any time during the trial
Time frame: Any time during the 12 weeks of the trial
Plan to share: No
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