OnabotulinumtoxinA is effective in patients with urinary incontinence due to neurogenic detrusor overactivity [corrected] regardless of concomitant anticholinergic use or neurologic etiology

• Published in: Advances in therapy 2013-09, Vol.30 (9), p.819
• Main Authors: Ginsberg, David, Cruz, Francisco, Herschorn, Sender, Gousse, Angelo, Keppenne, Véronique, Aliotta, Philip, Sievert, Karl-Dietrich, Brin, Mitchell F, Jenkins, Brenda, Thompson, Catherine, Lam, Wayne, Heesakkers, John, Haag-Molkenteller, Cornelia
• Format: Article
• Language: English
• Subjects: Adult; Botulinum Toxins, Type A - therapeutic use; Cholinergic Antagonists - therapeutic use; Double-Blind Method; Female; Humans; Injections, Intramuscular; Male; Middle Aged; Multiple Sclerosis - complications; Neuromuscular Agents - therapeutic use; Spinal Cord Injuries - complications; Treatment Outcome; Urinary Bladder; Urinary Bladder, Neurogenic - drug therapy; Urinary Bladder, Neurogenic - etiology; Urinary Bladder, Overactive - drug therapy; Urinary Bladder, Overactive - etiology; Urinary Incontinence - drug therapy; Urinary Incontinence - etiology; Urodynamics
• ISSN: 1865-8652
• DOI: 10.1007/s12325-013-0054-z

To evaluate the efficacy and safety of onabotulinumtoxinA for the treatment of neurogenic detrusor overactivity (NDO) in subpopulations of etiology (multiple sclerosis [MS] or spinal cord injury [SCI]) and concomitant anticholinergics (use/non-use). Data were pooled from two double-blind, placebo-controlled, pivotal, phase 3 studies including a total of 691 patients with ≥ 14 urinary incontinence (UI) episodes/week due to MS (n = 381) or SCI (n = 310). Patients received intradetrusor injections of onabotulinumtoxinA 200U (n = 227), 300U (n = 223), or placebo (n = 241). Change from baseline at week 6 in UI episodes/week (primary endpoint), urodynamics, quality of life (QOL), and adverse events (AEs) were assessed. Significant and similar reductions in UI episodes were observed regardless of etiology or anticholinergic use: at week 6, mean weekly decreases of -22.6 and -19.6 were seen in MS and SCI patients, respectively, and -20.3 and -22.5 in anticholinergic users and non-users, respectively, treated with onabotulinumtoxinA 200U. The 300U dose did not add to the clinical efficacy in any subpopulation. Similar proportions of patients achieved ≥ 50% or 100% reductions in UI episodes in all subgroups. Improvements in maximum cystometric capacity, maximum detrusor pressure during first involuntary detrusor contraction, and QOL were significant in both etiologies and were independent of anticholinergic use. The most common AEs in all groups were urinary tract infection and urinary retention. Regardless of concomitant anticholinergic use or etiology, onabotulinumtoxinA significantly improved UI symptoms, urodynamics, and QOL in patients with UI due to NDO. OnabotulinumtoxinA was well tolerated in all groups.