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ESNM2 Idiopathic overactive bladder syndrome: botulinum toxin A

Key points from the evidence

Botulinum toxin A (BOTOX, Allergan) is currently undergoing product licence application in the UK and Europe for the treatment of urinary incontinence in people with idiopathic overactive bladder syndrome (IOAB) not adequately controlled with anticholinergic therapy. NICE guidance on the management of urinary incontinence in women and lower urinary tract symptoms advises that botulinum toxin A should be used for the treatment of IOAB with detrusor overactivity (DO) only in people who have not responded to lifestyle interventions, bladder retraining and pharmacological treatment and who are willing and able to self-catheterise.

Since the NICE guidelines were issued, published evidence from a randomised controlled trial by Tincello et al. suggests that bladder wall injection of botulinum toxin A 200 units significantly improves urinary frequency, urgency and incontinence in women with IOAB and DO. At 6 months 31% of women receiving treatment were continent, compared with 12% of those receiving placebo (number needed to treat 5). However, balancing these benefits against the risks of treatment at 6 months, the number of women reporting at least 1 urinary tract infection (UTI) or voiding difficulties needing intermittent self-catheterisation (ISC) was significantly higher with botulinum toxin A than with placebo (number needed to harm 5 for botulinum toxin A and 8 for placebo).

It should be noted that study participants were required to have tried only 1 anticholinergic drug, whereas NICE advises than an alternative should be tried if the first-line option, oxybutynin, is not tolerated.

When considering the use of botulinum toxin A for these conditions, local decision makers will need to consider its use alongside other surgical options recommended by NICE such as sacral nerve stimulation and augmentation cystoplasty, considering their relative clinical and cost effectiveness.

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This page was last updated: 17 September 2012

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Accessibility | Cymraeg | Freedom of information | Vision Impaired | Contact Us | Glossary | Data protection | Copyright | Disclaimer | Terms and conditions

Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.