UK-BUO-220047. DOP: April 2022.
BOTOX®: Tried and tested for treating neurogenic detrusor overactivity (NDO)5*
BOTOX®: significant improvements for NDO patients5,6
Study context: Two double-blind, placebo controlled, randomised phase 3 clinical studies, in 691 patients with urinary incontinence due to NDO, as a result of multiple sclerosis or spinal cord injury who were inadequately managed by ≥1 anticholinergic agent. To assess the efficacy, safety and effects on quality of life of BOTOX® patients with NDO. The primary end point was the mean number of UI episodes per week at Week 6 after treatment. Secondary end points were the mean increase in bladder capacity, maximum detrusor pressure during first involuntary detrusor contraction and incontinence related quality of life. BOTOX®: n=227, placebo: n=241. Baseline weekly frequency of UI score: BOTOX® 200 U 32.4, placebo 31.5.5
†p<0.001 vs. placebo.
3 reasons to trust BOTOX® in your NDO patients:
Safety and tolerability experience from +30 years of use in a range of conditions2-4,8-10
I-QoL: Incontinence-quality of life; NDO: neurogenic detrusor overactivity; UI: urinary incontinence.
*BOTOX® is indicated for the management of bladder dysfunctions in adult patients who are not adequately managed with anticholinergics: neurogenic detrusor overactivity with urinary incontinence due to subcervical spinal cord injury (traumatic or non-traumatic), or multiple sclerosis.5
- Allergan. Data on file. INT/0423/2016
- Aurora S K, Winner P et al. OnabotulinumtoxinA for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache 2011;51(9):1358-1373
- Blumenfeld A M, Stark R J et al. Long-term study of the efficacy and safety of OnabotulinumtoxinA for the prevention of chronic migraine: COMPEL study. J Headache Pain 2018;19(1):13
- Allergan Ltd. Data on file 014
- BOTOX® Summary of Product Characteristics. Available at: https://www.medicines.org.uk/. Accessed April 2022
- Kennelly M, Dmochowski R et al. Efficacy and safety of onabotulinumtoxinA therapy are sustained over 4 years of treatment in patients with neurogenic detrusor overactivity: final results of a long‐term extension study. Neurourology and Urodynamics 2015;1-8
- Rovner E, Kohan A et al. Long-term efficacy and safety of onabotulinumtoxinA in patients with neurogenic detrusor overactivity who completed 4 years of treatment. J Urol 2016;196(3):801-808
- Allergan Ltd. Data on file. INT/0572/2016
- Allergan Ltd. Data on file. INT/0721/2017
- Rothrock J F, Adams JF et al. A Multicenter, Prospective, Randomized, Open-Label Study to Compare the Efficacy, Safety, and Tolerability of OnabotulinumtoxinA and Topiramate for Headache Prophylaxis in Adults with Chronic Migraine: The FORWARD Study. European Headache Federation (EHF) 2017; 3rd December presentation
Please refer to the BOTOX® Summary of Product Characteristics for further information on adverse events, contraindications and special warnings and precautions for use.
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/
Adverse events should also be reported to AbbVie on [email protected]
Date of preparation: June 2022. UK-BUO-220033.