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      Administering BOTOX® for your overactive bladder (OAB) patients*

      BOTOX® provides approximately 6 months of symptom relief5

      • Instill with enough saline to visualise empty bladder wall for the injections  and avoid backflow of the product,  but over-distension should be avoided6
      • Reconstituted BOTOX® is injected via a flexible or rigid cystoscope6
      • The needle should be inserted approximately 2 mm into the detrusor and 20 injections of 0.5 ml each (total volume of 10 ml) should be spaced approximately 1 cm apart6
      • The recommended dose for OAB is 100 Units, as 0.5 ml (5 Units) injections across 20 sites in the detrusor muscle6
      • Patients should be considered for reinjection when the clinical effect of the previous injection has diminished but no sooner than 3 months from the prior bladder injection6

      Botulinum toxins are not interchangeable with
      each other6

      Please follow the SmPC for reconstitution protocol (section 6.6). For the patient preparation and post-injection monitoring, please see section 4.4 of the SmPC


      BOTOX® in overactive bladder: Treatment benefit sustained over time5

      BOTOX® sustained reductions in daily episodes of UI and urgency from baseline, throughout the entire 3.5 year study period†5

      Adapted from Nitti VW, et al. 2016.5

      Study context: The final results of the prospective, multicentre, long-term (3.5 year) study of the efficacy/safety of BOTOX® for overactive bladder syndrome. The co-primary endpoints were the mean reduction in UI episodes per day and the proportion of patients reporting a positive response on the treatment benefit scale. In the overall population the most common AEs within the first 12 weeks of BOTOX® treatment were localised to the urinary tract. There was no evidence of increasing occurence of these AEs with repeat treatments, UTI was the most frequently reported AE5

      n values denote the number of patients with data available at week 12 post treatment. Error bars represent 95% confidence intervals.


      Overall median duration of effect was 7.6 months5

      Duration of botulinum toxin type A effect based on time to patient request for re-treatment‡5

      Adapted from Nitti VW, et al. 2016.5

      Study context: The final results of the prospective, multicenter, long-term (3.5 year) study of the efficacy/safety of BOTOX® for overactive bladder syndrome.5

      Median duration in patients (n=428) who received BOTOX® only throughout study with complete treatment cycles, with 1 month defined as 4 weeks. Total study duration 3.5 years. Patients recieved up to 6 treatment cycles.5


      AE, adverse event; BL: baseline; SmPC: summary of product characteristics; UI: urinary incontinence; UTI: urinary tract infection.

      *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.6

       

      References

      1. Allergan. Data on file. INT/0423/2016
      2. 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
      3. 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
      4. Allergan Ltd. Data on file 014
      5. 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
      6. BOTOX® Summary of Product Characteristics. Available at: www.medicines.org.uk. Accessed April 2022

      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 GBPV@abbvie.com 

       

      Date of preparation: April 2022. UK-BUO-220014.