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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: neurogenic detrusor overactivity with urinary incontinence due to subcervical spinal cord injury (traumatic or non-traumatic), or multiple sclerosis.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: neurogenic detrusor overactivity with urinary incontinence due to subcervical spinal cord injury (traumatic or non-traumatic), or multiple sclerosis.5

      UK-BUO-240005. DOP: April 2024.

      Treatment options for neurogenic detrusor overactivity (NDO)

      The goals of NDO treatment are to protect the upper urinary tract, achieve (or maintain) urinary continence, improve patients’ quality of life and restore lower urinary tract function.6,7 Additional considerations are the potential for future complications, the patient’s condition, and the ease and cost-effectiveness of treatment.6

      Treatment options for NDO include:5,7

       Lifestyle advice/behavioural approaches

       Assisted emptying

       Containment

       Pharmacotherapy

       Botulinum toxin type A

       Neurostimulation

       Surgery

      Lifestyle/behavioural interventions for NDO include the use of regular voiding schedules and pelvic floor muscle exercises.6

      Patients can be taught how to void by abdominal stimulation (triggered reflex voiding) or abdominal straining.6

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

      Anticholinergics are widely used treatment for urgency urinary incontinence, but there is limited evidence supporting their use in NDO. Higher doses of anticholinergics can be related to a higher rate of side effects, while other potential limitations include drug-drug interactions, low rates of patient adherence and cognitive effects in the elderly.8–13 For patients in whom oral therapy is not effective, options include botulinum toxin type A, sacral anterior root stimulation, sacral nerve stimulation and surgery.

      Sacral anterior root stimulation involves implantation of a device that enables patients with a spinal cord lesion to empty their bladders via stimulation of the sacral anterior roots.13

      Sacral nerve stimulation aims to rebalance micturition via electrical stimulation of the sacral nerve roots.14,15 

      Enterocystoplasty involves enlargement of the bladder by grafting to it a detached segment of intestine.16

      Urinary diversion involves the creation of a new bladder outlet with a valve for urinary continence, which is catheterised to empty.17,18

      An autologous urethral sling made from the patient’s own body tissue and placed under the urethra to hold it closed when the bladder is pushed downwards, preventing urine leakage is an option for female patients.6

      NICE recommends bladder wall injection with botulinum toxin type A as an option for adults:17

       With spinal cord disease (e.g. spinal cord injury or multiple sclerosis) and

       With symptoms of an overactive bladder and

       In whom antimuscarinic drugs have proved to be ineffective or poorly tolerated

      The EAU guidelines recommend botulinum toxin injection in the detrusor as an option to reduce neurogenic detrusor overactivity in patients with multiple sclerosis or spinal cord injury if antimuscarinic therapy is ineffective.7

      BOTOX® is the only botulinum toxin type A currently 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; neurogenic detrusor overactivity with urinary incontinence due to sub cervical spinal cord injury (traumatic or non-traumatic) or multiple sclerosis.5

      The goals of NDO treatment are to protect the upper urinary tract, achieve (or maintain) urinary continence, improve patients' quality of life and restore lower urinary tract function6,7

      NDO: neurogenic detrusor overactivity.

      WHY CONSIDER BOTOX®

       

      © NICE [2012] Urinary incontinence in neurological disease. 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. Stöhrer M, Blok B et al. EAU guidelines on neurogenic lower urinary tract dysfunction. Eur Urol. 2009;56:81–8
      7. Blok B, et al. EAU Guidelines on Neuro-Urology 2022. Available from: https://d56bochluxqnz.cloudfront.net/documents/full-guideline/EAU-Guidelines-on-Neuro-Urology-2022.pdf. Last accessed April 2024. 
      8. Chapple C R, Yamanishi T and Chess-Williams R. Muscarinic receptor subtypes and management of the overactive bladder. Urology. 2002;60(5):82-88
      9. Chapple C R, Khullar V et al. The effects of antimuscarinic treatments in overactive bladder: an update of a systematic review and meta-analysis. Eur Urol. 2008;54:543–62
      10. Andersson KE et al. Pharmacological treatment of urinary incontinence. 3rd International Consultation on Incontinence. 2004
      11. Wagg A, Compion G et al. Persistence with prescribed antimuscarinic therapy for overactive bladder: a UK experience. BJU Int. 2012;110:1767–74
      12. Gray S L, Anderson M L et al. Cumulative use of strong anticholinergics and incident dementia: a prospective cohort study. JAMA Intern Med. 2015;175:401–7
      13. Guiho T, Azevedo-Coste C et al. Sacral Anterior Root Stimulation and Visceral Function Outcomes in Spinal Cord Injury–A Systematic Review of the Literature Over Four Decades. World Neurosurg. 2022;157:218-232.e14
      14. Oerlemans DJAJ, van Kerrebrock PEV. Sacral nerve stimulation for neuromodulation of the lower urinary tract. Neururol Urodyn. 2008;27:28–33
      15. Sanford M T and Suskind A M. Neuromodulation in neurogenic bladder. Transl Abdrol Urol. 2016;5:117–126 
      16. Abrams P et al. Incontinence: 6th Edition 2017;50
      17. National Institute for Health and Care Excellence (NICE). CG148: Urinary incontinence in neurological disease. Available at: https://www.nice.org.uk/guidance/cg148. Accessed April 2024
      18. de Jong TPVM, Chrzan R et al. Treatment of the neurogenic bladder in spina bifida. Pediatr Nephrol. 2008;23:889–9

       

      © NICE [2012] Urinary incontinence in neurological disease. 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. Stöhrer M, Blok B et al. EAU guidelines on neurogenic lower urinary tract dysfunction. Eur Urol. 2009;56:81–8
      7. Blok B, et al. EAU Guidelines on Neuro-Urology 2022. Available from: https://d56bochluxqnz.cloudfront.net /documents/full-guideline/EAU-Guidelines-on-Neuro-Urology-2022.pdf. Last accessed April 2024. 
      8. Chapple C R, Yamanishi T and Chess-Williams R. Muscarinic receptor subtypes and management of the overactive bladder. Urology. 2002;60(5):82-88
      9. Chapple C R, Khullar V et al. The effects of antimuscarinic treatments in overactive bladder: an update of a systematic review and meta-analysis. Eur Urol. 2008;54:543–62
      10. Andersson KE et al. Pharmacological treatment of urinary incontinence. 3rd International Consultation on Incontinence. 2004
      11. Wagg A, Compion G et al. Persistence with prescribed antimuscarinic therapy for overactive bladder: a UK experience. BJU Int. 2012;110:1767–74
      12. Gray S L, Anderson M L et al. Cumulative use of strong anticholinergics and incident dementia: a prospective cohort study. JAMA Intern Med. 2015;175:401–7
      13. Guiho T, Azevedo-Coste C et al. Sacral Anterior Root Stimulation and Visceral Function Outcomes in Spinal Cord Injury–A Systematic Review of the Literature Over Four Decades. World Neurosurg. 2022;157:218-232.e14
      14. Oerlemans DJAJ, van Kerrebrock PEV. Sacral nerve stimulation for neuromodulation of the lower urinary tract. Neururol Urodyn. 2008;27:28–33
      15. Sanford M T and Suskind A M. Neuromodulation in neurogenic bladder. Transl Abdrol Urol. 2016;5:117–126 
      16. Abrams P et al. Incontinence: 6th Edition 2017;50
      17. National Institute for Health and Care Excellence (NICE). CG148: Urinary incontinence in neurological disease. Available at: https://www.nice.org.uk/guidance /cg148. Accessed April 2024
      18. de Jong TPVM, Chrzan R et al. Treatment of the neurogenic bladder in spina bifida. Pediatr Nephrol. 2008;23:889–9

      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-240015.

       

       

      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.