UK-BUO-220048. DOP: April 2022.
BOTOX®: Tried and tested for treating overactive bladder (OAB)5*
Study context: Two double-blind, placebo-controlled, randomised, 24-week phase 3 clinical studies were conducted in 1105 patients with overactive bladder, with symptoms of urge urinary incontinence, urgency and frequency, whose symptoms had not been adequately managed with at least one anticholinergic therapy. To evaluate the impact of efficacy, safety and health-related quality of life of BOTOX® in patients with OAB with UI. Patients were randomised to receive either 100 U of BOTOX® (n=557) or placebo (n=548). The co-primary end points were the mean reduction in UI episodes per day and the proportion of patients reporting a positive response on the TBS at week 12. Secondary end points were the change from baseline in daily frequency of micturition episodes, urgency episodes and health related quality of life. Mean baseline for daily UI episodes: BOTOX® 100 U 5.49/day, placebo 5.39/day. Mean baseline for daily urgency episodes: BOTOX® 100mU 8.82/day, placebo 8.31/day.5
†P<0.001 vs placebo.
‡Dry patients over a 3-day diary.
3 reasons to trust BOTOX® in your OAB patients
Safety and tolerability experience from 30 years of use in a range of conditions1-3,5,8,9
CIC: clean intermittent catheterisation; OAB: overactive bladder; TBS: treatment benefit scale; UI: urinary incontnence.
*BOTOX® is indicated for the management of bladder dysfunctions in adult patients who are not adequately managed with anticholinergics: overactive bladder with symptoms of urinary incontinence, urgency and frequency.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. www.medicines.org.uk. Accessed April 2022
- Nitti V W, Ginsberg D et al. Durable efficacy and safety of long-term onabotulinumtoxinA treatment in patients with overactive bladder syndrome: final results of a 3.5-year study. The Journal of Urology 2016;196(3),791-800
- Sievert K D, Chapple C et al. OnabotulinumtoxinA 100U provides significant improvements in overactive bladder symptoms in patients with urinary incontinence regardless of the number of anticholinergic therapies used or reason for inadequate management of overactive bladder. Int J Clin Practice 2014;68:1246-1256
- Allergan Ltd. Data on file. INT/0527/2016
- Allergan Ltd. Data on file. INT/0721/2017
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: May 2022. UK-BUO-220011.