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      • This website is for UK Healthcare Professionals only

      UK-BUO-220047. DOP: April 2022.

      Reduce the impact of neurogenic detrusor overactivity (NDO) on your patients' lives

      BOTOX®: significant and sustained improvements for NDO patients*5,6

      Reduction from baseline in UI episodes at Week 6 (BOTOX®: n=227)5†

      Significant I-QoL improvements at Weeks 6 and 12 (BOTOX®: n=227)5†

      Of NDO patients were completely dry at Week 6 (BOTOX®: n=227)5

      Increase in bladder capacity at Week 6 (BOTOX®: n=227)5†

      Study context: Two double-blind, placebo controlled, randomised phase 3 clinical studies, in 691 patients with urinary incontinence due to NDO, as a result of multiple sclerosis or spinal cord injury who were inadequately managed by ≥1 anticholinergic agent. To assess the efficacy, safety and effects on quality of life of BOTOX® patients with NDO. The primary end point was the mean number of UI episodes per week at Week 6 after treatment. Secondary end points were the mean increase in bladder capacity, maximum detrusor pressure during first involuntary detrusor contraction and incontinence related quality of life. BOTOX®: n=227, placebo: n=241. Baseline weekly frequency of UI score: BOTOX® 200 U 32.4, placebo 31.5.5

      † p<0.001 vs. placebo. 

      BOTOX® 200 U provides 61% reduction in UI episodes from a single treatment at week 65

      Adapted from BOTOX® Summary of Product Characteristics. Accessed April 20225

      Study context: Two double-blind, placebo controlled, randomised phase 3 clinical studies, in 691 patients with urinary incontinence due to NDO, as a result of multiple sclerosis or spinal cord injury who were inadequately managed by ≥1 anticholinergic agent. To assess the efficacy, safety and effects on quality of life of BOTOX® patients with NDO. The primary end point was the mean number of UI episodes per week at Week 6 after treatment. Secondary end points were the mean increase in bladder capacity, maximum detrusor pressure during first involuntary detrusor contraction and incontinence related quality of life. BOTOX®: n=227, placebo: n=241. Baseline weekly frequency of UI score: BOTOX® 200 U 32.4, placebo 31.5.5

      †p<0.001 vs. placebo. 

      BOTOX® 200 U: Significant I-QOL improvements at weeks 6 and 125

      Adapted from BOTOX® Summary of Product Characteristics. Accessed April 20225

      Study context: Two double-blind, placebo controlled, randomised phase 3 clinical studies, in 691 patients with urinary incontinence due to NDO, as a result of multiple sclerosis or spinal cord injury who were inadequately managed by ≥1 anticholinergic agent. To assess the efficacy, safety and effects on quality of life of BOTOX® patients with NDO. The primary end point was the mean number of UI episodes per week at Week 6 after treatment. Secondary end points were the mean increase in bladder capacity, maximum detrusor pressure during first involuntary detrusor contraction and incontinence related quality of life. BOTOX®: n=227, placebo: n=241. Baseline weekly frequency of UI score: BOTOX® 200 U 32.4, placebo 31.5.5

      †p<0.001 vs. placebo. 

      BOTOX® 200 U: 37% of patients were dry by week 65

      Adapted from BOTOX® Summary of Product Characteristics. Accessed April 20225

      Study context: Two double-blind, placebo controlled, randomised phase 3 clinical studies, in 691 patients with urinary incontinence due to NDO, as a result of multiple sclerosis or spinal cord injury who were inadequately managed by ≥1 anticholinergic agent. To assess the efficacy, safety and effects on quality of life of BOTOX® patients with NDO. The primary end point was the mean number of UI episodes per week at Week 6 after treatment. Secondary end points were the mean increase in bladder capacity, maximum detrusor pressure during first involuntary detrusor contraction and incontinence related quality of life. BOTOX®: n=227, placebo: n=241. Baseline weekly frequency of UI score: BOTOX® 200 U 32.4, placebo 31.5.5

      BOTOX® increases bladder capacity in patients with urinary incontinence due to NDO (secondary end point)5

      Adapted from BOTOX® Summary of Product Characteristics. Accessed April 20225

      Study context: Two double-blind, placebo controlled, randomised phase 3 clinical studies, in 691 patients with urinary incontinence due to NDO, as a result of multiple sclerosis or spinal cord injury who were inadequately managed by ≥1 anticholinergic agent. To assess the efficacy, safety and effects on quality of life of BOTOX® patients with NDO. The primary end point was the mean number of UI episodes per week at Week 6 after treatment. Secondary end points were the mean increase in bladder capacity, maximum detrusor pressure during first involuntary detrusor contraction and incontinence related quality of life. BOTOX®: n=227, placebo: n=241. Baseline weekly frequency of UI score: BOTOX® 200 U 32.4, placebo 31.5.5

      †Bladder capacity was defined as maximum cystometric capacity and is shown as mean change from baseline.

      I-QoL: Incontinence-quality of life; NDO: neurogenic detrusor overactivity; UI: urinary incontinence.

      *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

      VIEW SAFETY DATA FOR BOTOX®

       

      References

      1. Allergan Ltd. Data on file 014
      2. Allergan. Data on file. INT/0423/2016
      3. 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
      4. 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
      5. BOTOX® Summary of Product Characteristics. Available at: https://www.medicines.org.uk/. Accessed April 2022
      6. Kennelly M, Dmochowski R et al. Efficacy and safety of onabotulinumtoxinA therapy are sustained over 4 years of treatment in patients with neurogenic detrusor overactivity: final results of a long‐term extension study. Neurourology and Urodynamics 2015;1-8

      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: June 2022. UK-BUO-220023.