+30 YEARS' GLOBAL EXPERIENCE ACROSS MULTIPLE INDICATIONS1-4
UROLOGY
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
References
- Allergan Ltd. Data on file 014
- Allergan. Data on file. INT/0423/2016
- 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
- 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
- BOTOX® Summary of Product Characteristics. Available at: https://www.medicines.org.uk/. Accessed April 2022
- 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.
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 [email protected]
Date of preparation: June 2022. UK-BUO-220023.
