Platinum Priority – Incontinence Editorial by Ricarda M. Bauer and Christian Gratzke on pp. 158–159 of this issue OnabotulinumtoxinA Improves Health-Related Quality of Life in Patients With Urinary Incontinence Due to Idiopathic Overactive Bladder: A 36-Week, Double-Blind, Placebo-Controlled, Randomized, Dose-Ranging Trial Clare J. Fowler a, *, Stephen Auerbach b , David Ginsberg c , Douglass Hale d , Piotr Radziszewski e , Tomasz Rechberger f , Vaishali D. Patel g , Jihao Zhou g , Catherine Thompson h , Jonathan W. Kowalski g a The National Hospital for Neurology and Neurosurgery, London, UK; b California Professional Research, Newport Beach, CA, USA; c Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA; d Indiana University/Methodist Hospital, Indianapolis, IN, USA; e Department of Urology, Medical University of Warsaw, Warsaw, Poland; f Medical University of Lublin, Lublin, Poland; g Allergan, Inc., Irvine, CA, USA; h Allergan Ltd., Marlow, UK EUROPEAN UROLOGY 62 (2012) 148–157 available at www.sciencedirect.com journal homepage: www.europeanurology.com Article info Article history: Accepted March 5, 2012 Published online ahead of print on March 13, 2012 Keywords: Botulinum toxin type A Overactive bladder Quality of life Urgency incontinence Abstract Background: Patients with urgency urinary incontinence (UUI) due to overactive bladder (OAB) refractory to oral antimuscarinics have limited therapeutic options. OnabotulinumtoxinA appears to be an effective new treatment. Objective: Assess disease-specific quality-of-life outcomes and general health–related quality-of-life (HRQOL) outcomes following treatment with onabotulinumtoxinA in patients with idiopathic OAB and UUI inadequately managed with antimuscarinics. Design, setting, and participants: A phase 2, randomized, double-blind, placebo- controlled, dose-ranging study conducted at 40 sites from July 2005 to June 2008 with 313 patients (288 females) with idiopathic OAB experiencing eight or more UUI episodes per week and eight or more micturitions per day at baseline, with follow-up of 36 wk. Intervention: Intradetrusor onabotulinumtoxinA (50 U, 100 U, 150 U, 200 U, or 300 U) or placebo. Outcome measurements and statistical analysis: HRQOL was assessed using the urinary Incontinence-Specific Quality-of-Life Instrument (I-QOL), the King’s Health Question- naire (KHQ) symptom component, and the Medical Outcomes Study 36-Item Short- Form Health Survey. Descriptive statistics were used for absolute scores/changes from baseline. Within-group changes from baseline were assessed using paired t tests. Change from baseline for each onabotulinumtoxinA group compared with placebo was analyzed using an analysis of covariance model. Results and limitations: OnabotulinumtoxinA treatment at doses 100 U produced significantly greater improvements than placebo in the I-QOL total and subscale scores at all follow-up visits from week 2 through week 24 ( p < 0.05). OnabotulinumtoxinA doses 100 U produced significantly greater improvements than placebo in the KHQ symptom score at a majority of follow-up visits. HRQOL instruments demonstrated low to moderate correlations (Spearman correlation range: 0.01–0.51) with the symptoms of UUI recorded using daily diary data, with I-QOL demonstrating the highest correlations. A study limitation was that certain quality-of-life measures were exploratory and not validated. * Corresponding author. The National Hospital for Neurology and Neurosurgery, Queen Square, London WC1N 3BG, UK. Tel. +44 20 7837 3611 ext. 3418. E-mail address: C.Fowler@ion.ucl.ac.uk (C.J. Fowler). 0302-2838/$ – see back matter # 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved. doi:10.1016/j.eururo.2012.03.005