OnabotulinumtoxinA Improves Urodynamic Outcomes in Patients With Neurogenic Detrusor Overactivity

AimsTo evaluate the effect of onabotulinumtoxinA on urodynamic outcomes in patients with urinary incontinence (UI) due to neurogenic detrusor overactivity (NDO). MethodsResults from two pivotal Phase III trials (n=691) were pooled. MS or SCI patients with NDO, received intradetrusor onabotulinumtoxinA 200U (n=227), 300U (n=223), or placebo (n=241). Change from baseline in UI episodes/week (Week 6), maximum cystometric capacity (MCC), maximum detrusor pressure at first involuntary detrusor contraction (IDC) (P-detmaxIDC), volume at first IDC (V-pmaxIDC), and detrusor compliance (DC) were measured. ResultsOnabotulinumtoxinA significantly increased MCC overall (+153.6ml with 200U vs. +11.9ml with placebo). Over 60% of onabotulinumtoxinA-treated patients had no IDC at Week 6; in patients with an IDC at Week 6, V-pmaxIDC improved (+183.4ml with 200U vs. +17.5ml with placebo), and P-detmaxIDC decreased (-32.4cmH(2)O with 200U vs. +1.1cmH(2)O with placebo). OnabotulinumtoxinA-treated patients had a significant increase in DC (+59.8ml/cmH(2)O with 200U vs. -5.2 with placebo). Urodynamic improvements were comparable in patients regardless of baseline DC and corresponded with significant reductions in UI episodes/week for both onabotulinumtoxinA doses versus placebo, with no clinically relevant differences between 200 and 300U groups. Most common adverse event was urinary tract infection (UTI); complicated UTIs were low across all treatment groups. In patients not catheterizing at baseline, a dose-dependent increase in post-void residual urine was observed at Week 2 following onabotulinumtoxinA treatment. ConclusionsOnabotulinumtoxinA significantly improved urodynamic outcomes in NDO patients, even in those with low baseline DC, and corresponded with improvements in UI episodes. Both doses of onabotulinumtoxinA were well tolerated. Neurourol. Urodynam. 32:1109-1115, 2013. (c) 2013 Wiley Periodicals, Inc.