title: Chapter 5: Clinical data in neurogenic detrusor overactivity (NDO) and overactive bladder (OAB).
abstract: Following use of botulinum toxin in the 1980s for the treatment of detrusor sphincter dyssynergia in patients with spinal cord injury (SCI), the potential therapeutic value of this neurotoxin in urology has been the subject of much interest. The DIGNITY (Double-blind InvestiGation of purified Neurotoxin complex In neurogenic deTrusor overactivitY) clinical research program aimed to compare onabotulinumtoxinA with placebo in terms of efficacy and safety in patients with neurogenic detrusor overactivity (NDO) due to SCI or multiple sclerosis. The EMBARK clinical research program mirrored these aims in patients with overactive bladder with urinary incontinence (UI). Each program comprised two phase III, randomized, placebo-controlled studies. In all four trials, primary efficacy endpoints were met, and significant benefits of onabotulinumtoxinA versus placebo were demonstrated across a range of secondary endpoints, including measures of health-related quality of life. The most common adverse event across both programs was urinary tract infection. Interim analyses of data from ongoing long-term extensions to these phase III trials have provided promising evidence for the efficacy of repeated injections. While further investigation is recommended to enrich the dataset, the available evidence indicates that onabotulinumtoxinA provides an effective treatment option for these two populations, which were previously considered very difficult to treat.
authors.affiliation: Hospital São João, IBMC & Faculty of Medicine do Porto, Porto, Portugal.
authors.forename: Francisco
authors.initials: F
authors.lastname: Cruz
authors.forename: Victor
authors.initials: V
authors.lastname: Nitti
mesh_terms: D019274:Botulinum Toxins, Type A / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D009465:Neuromuscular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D001743:Urinary Bladder / Q000187:drug effects* / Q000294:innervation*; D001750:Urinary Bladder, Neurogenic / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D053201:Urinary Bladder, Overactive / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D014563:Urodynamics / Q000187:drug effects
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A
keywords: BOTOX; botulinum toxins; neurogenic; onabotulinumtoxinA; overactive urinary bladder; type A; urinary bladder