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      • This website is for UK Healthcare Professionals only
      Prescribing Information
      BOTOX® SMPC
      RESOURCES

      +30 YEARS' GLOBAL EXPERIENCE
      ACROSS MULTIPLE INDICATIONS1-4

       

      UROLOGY

      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
      Prescribing Information
      BOTOX® SMPC
      RESOURCES

      +30 YEARS' GLOBAL EXPERIENCE ACROSS MULTIPLE INDICATIONS1-4

      UROLOGY

      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

      UK-BUO-240019. DOP: April 2024.

      Treatment options for overactive bladder (OAB)

      The treatment of OAB is aimed at reducing symptoms to improve patients’ overall quality of life.

      Treatments for OAB include:6

      • Lifestyle interventions
      • Containment
      • Pharmacotherapy
      • Botulinum toxin type A
      • Posterior tibial nerve stimulation
      • Sacral nerve stimulation
      • Surgery

      Lifestyle interventions for OAB include weight reduction, reduced caffeine intake, bladder training, modified fluid intake and pelvic floor muscle training.6

      Containment approaches for OAB include temporary urinary containment products (such as absorbent pads, waterproof pants and external sheaths) and intermittent self-catheterisation.6

      Anticholinergics are the most widely used treatment for OAB but can be associated with high rates of treatment discontinuation, mainly due to lack of efficacy and side effects.7-10 The beta-3 adrenergic agonist mirabegron is an option for patients who stop using anticholinergics.6 For patients in whom oral therapy is not effective, options include botulinum toxin type A, posterior tibial nerve stimulation, sacral neuromodulation and surgery.7-10

      Electrical stimulation of the posterior tibial nerve delivers electrical stimuli to the sacral micturition centre. Typically, the posterior tibial nerve is stimulated with a fine, 34-G needle, inserted just above the ankle. Treatment cycles typically consist of once-weekly treatments of 30 minutes for a total of 12 weeks.10

      Sacral nerve stimulation

      The goal of sacral nerve stimulation is to rebalance micturition via electrical stimulation of the sacral nerve roots.11,12

      Cystoplasty/urinary diversion 

      Urinary diversion involves the creation of a new bladder outlet with a valve for urinary continence, which is catheterised to empty. No studies have specifically examined this technique in non-neurogenic urinary incontinence.10

      Augmentation cystoplasty involves grafting a detached segment of intestine to enlarge the bladder. Associated with high risks of short-term and long-term severe complications.10

      Botulinum toxin type A

      National Institute for Health and Care Excellence (NICE) recommends bladder wall injection with botulinum toxin type A as an option:6

      • For women with OAB caused by detrusor overactivity that has not responded to non-surgical management, including pharmacological treatments.
      • For women with symptoms of OAB in whom urodynamic investigation has not demonstrated detrusor overactivity, if the symptoms have not responded to non-surgical management and the woman does not wish to have other invasive treatments.

      The European Association of Urology (EAU) guidelines recommend botulinum toxin type A and BOTOX® as an option for patients with urge urinary incontinence that is refractory to conservative therapy. Patients should be counselled on the limited duration of response, risk of urinary tract infections and the possible prolonged need to self-catheterise.10

      OAB is a complex, multi-symptom syndrome that can be difficult to treat13

      OAB: overactive bladder.

      BOTOX® for OAB

       

      ©NICE [2019] Urinary incontinence and pelvic organ prolapse in women: management. Available from nice.org.uk. All rights reserved. Subject to Notice of rights

      NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.

      References

      1. Allergan. Data on file. INT/0423/2016
      2. Aurora S K, Winner P et al. Onabotulinum toxin A for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache. 2011;51(9):1358-1373
      3. Blumenfeld A M, Stark R J et al. Long-term study of the efficacy and safety of onabotulinum toxin A for the prevention of chronic migraine: COMPEL study. J Headache Pain. 2018;19(1):13
      4. AbbVie Data on file. Approval Dates for BOTOX® in UK. UK-BTX-230044. April 2023
      5. BOTOX® Summary of Product Characteristics. Available from: https://www.medicines.org.uk/emc/product/859/smpc. Accessed April 2024.
      6. National Institute for Health and Care Excellence (NICE). NG123: Urinary incontinence and pelvic organ prolapse in women: management. Available at: https://www.nice.org.uk/guidance/ng123. Accessed April 2024
      7. Chapple C R, Yamanishi T and Chess-Williams R. Muscarinic receptor subtypes and management of the overactive bladder. Urology. 2002;60(5):82-88
      8. Castro D, Miranda P et al. Assessment of reasons for overactive bladder treatment change. Acta Urol Esp. 2011;35:73–9
      9. Benner J S, Nichol M et al. Patient-reported reasons for discontinuing overactive bladder medication. BJU Int. 2010;105:1276–82
      10. EAU Guidelines on Urinary Incontinence in Adults. Available from: https://uroweb.org.  Accessed April 2024
      11. Oerlemans DJAJ, van Kerrebrock PEV. Sacral nerve stimulation for neuromodulation of the lower urinary tract. Neururol Urodyn. 2008;27:28–33
      12. Sanford M T and Suskind A M. Neuromodulation in neurogenic bladder. Transl Abdrol Urol. 2016;5:117-126
      13. Starkman J S, Smith C P and Staskin D R. Surgical options for drug-refractory overactive bladder patients. Reviews in Urology. 2010;12(2-3):e97

       

      ©NICE [2019] Urinary incontinence and pelvic organ prolapse in women: management. Available from nice.org.uk. All rights reserved. Subject to Notice of rights

      NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.

      References

      1. Allergan. Data on file. INT/0423/2016
      2. Aurora S K, Winner P et al. Onabotulinum toxin A for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache. 2011;51(9):1358-1373
      3. Blumenfeld A M, Stark R J et al. Long-term study of the efficacy and safety of onabotulinum toxin A for the prevention of chronic migraine: COMPEL study. J Headache Pain. 2018;19(1):13
      4. AbbVie Data on file. Approval Dates for BOTOX® in UK. UK-BTX-230044. April 2023
      5. BOTOX® Summary of Product Characteristics. Available from: https://www.medicines.org.uk /emc/product/859/smpc. Accessed April 2024.
      6. National Institute for Health and Care Excellence (NICE). NG123: Urinary incontinence and pelvic organ prolapse in women: management. Available at: https://www.nice.org.uk /guidance/ng123. Accessed April 2024
      7. Chapple C R, Yamanishi T and Chess-Williams R. Muscarinic receptor subtypes and management of the overactive bladder. Urology. 2002;60(5):82-88
      8. Castro D, Miranda P et al. Assessment of reasons for overactive bladder treatment change. Acta Urol Esp. 2011;35:73–9
      9. Benner J S, Nichol M et al. Patient-reported reasons for discontinuing overactive bladder medication. BJU Int. 2010;105:1276–82
      10. EAU Guidelines on Urinary Incontinence in Adults. Available from: https://uroweb.org.  Accessed April 2024
      11. Oerlemans DJAJ, van Kerrebrock PEV. Sacral nerve stimulation for neuromodulation of the lower urinary tract. Neururol Urodyn. 2008;27:28–33
      12. Sanford M T and Suskind A M. Neuromodulation in neurogenic bladder. Transl Abdrol Urol. 2016;5:117-126
      13. Starkman J S, Smith C P and Staskin D R. Surgical options for drug-refractory overactive bladder patients. Reviews in Urology. 2010;12(2-3):e97

      Please refer to the BOTOX® Summary of Product Characteristics for further information on adverse events, contraindications and special warnings and precautions for use.

      BOTOX® PRESCRIBING INFORMATION

       

      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 GBPV@abbvie.com 

       

      Date of preparation: April 2024. UK-BUO-240025.

       

       

      Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or via the MHRA Yellow Card app, available in the Google Play or Apple App Stores. Adverse events should also be reported to AbbVie on GBPV@abbvie.com

       

      This website is for UK Healthcare Professionals only

      UK-ABBV-230225. Date of preparation June 2023. This website has been developed and funded by AbbVie Ltd.

      © 2023 AbbVie Ltd. All rights reserved. Registered Number: 08004972 England.