OnabotulinumtoxinA (Botox A) for Neurogenic Detrusor; Evidence for 200 U vs. 300 U

Abstract OnabotulinumtoxinA (Botox A) has gone from investigational to a recognized standard for neurogenic detrusor overactivity (NDO) in patients intolerant or inadequately managed by anticholinergics. A large number of initial studies were done using the 300 unit dose, including the initial report on 200 vs. 300 U. There was a suggestion that 300 units may have some advantage but statistical sample size was small. Two pivotal phase 3 studies compare 200 units to 300 units of BotoxA for NDO. The result of these studies did not show an advantage to the higher dose. These studies did lead to the Food and Drug Administration (FDA) approval, in August 2011, of BotoxA 200 units for refractory or inadequately treated NDO patients. A subsequent pooled extension study was performed. Patients were then followed for five to eight treatment cycles of onabotulinumtoxinA. The data demonstrated no significant increased efficacy of the higher dose of onabotulinumtoxinA for patient management.
Source: Current Bladder Dysfunction Reports - Category: Urology & Nephrology Source Type: research