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.