MP80-12 SUSTAINED IMPROVEMENTS IN URINARY INCONTINENCE AND QUALITY OF LIFE OVER LONG-TERM TREATMENT WITH ONABOTULINUMTOXINA IN PATIENTS WITH URINARY INCONTINENCE DUE TO NEUROGENIC DETRUSOR OVERACTIVITY

Abstract

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Neurogenic Voiding Dysfunction1 Apr 2014MP80-12 SUSTAINED IMPROVEMENTS IN URINARY INCONTINENCE AND QUALITY OF LIFE OVER LONG-TERM TREATMENT WITH ONABOTULINUMTOXINA IN PATIENTS WITH URINARY INCONTINENCE DUE TO NEUROGENIC DETRUSOR OVERACTIVITY Michael Kennelly, Roger Dmochowski, Heinrich Schulte-Baukloh, Karen Ethans, Brenda Jenkins, Steven Guard, Ho-Jin Lee, and Gilles Karsenty Michael KennellyMichael Kennelly More articles by this author , Roger DmochowskiRoger Dmochowski More articles by this author , Heinrich Schulte-BauklohHeinrich Schulte-Baukloh More articles by this author , Karen EthansKaren Ethans More articles by this author , Brenda JenkinsBrenda Jenkins More articles by this author , Steven GuardSteven Guard More articles by this author , Ho-Jin LeeHo-Jin Lee More articles by this author , and Gilles KarsentyGilles Karsenty More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.2535AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES A large, multicenter study of the long-term efficacy/safety of onabotulinumtoxinA (onabotA) for treatment of urinary incontinence (UI) due to neurogenic detrusor overactivity (NDO) in patients (pts) not adequately managed with an anticholinergic was performed. Final results assessing UI and quality of life (QOL) following up to 4 years of onabotA treatment are presented. METHODS Pts who completed phase 3 studies (in which they received up to 2 onabotA treatments) could enter a 3-year extension study in which they received multiple intradetrusor onabotA treatments (initially pts received 200U or 300U, but after regulatory approval of onabotA 200U for treatment of UI due to NDO, all pts received 200U). Treatment schedules varied depending on pt request/need for retreatment and reaching a predefined UI threshold (provided ≥12 weeks had elapsed since previous treatment). Data are presented by treatment cycle (the number of onabotA treatments received; up to 8). Assessments included UI responder rates (proportions of pts with ≥50% or 100% reductions in UI), Incontinence-Quality of Life (I-QOL) total scores, and adverse events. RESULTS A total of 388 pts entered the long-term study and received ≥1 onabotA treatment over 4 years. The number of treatments required to maintain symptom control varied for each pt (range: 1-13 over 4 years). Most pts (77.9%) received 5 or fewer onabotA treatments. Of 662 complete treatment cycles in the 200U dose group, time to qualification for retreatment was <24 weeks in 25% of cycles and ≥24 weeks in 75% of cycles; 30% of cycles were ≥48 weeks. The proportions of pts with ≥50% reduction in UI episodes/day at week 6 after onabotA 200U were 67.5, 75.9, 80.0, 79.1, 82.7, 90.0, 87.5 and 83.3% (treatments 1-8, respectively). The proportions of continent pts (100% UI reduction at week 6) after onabotA 200U were 33.0, 39.0, 50.9, 52.3, 47.3, 47.1, 27.1, and 27.8%, respectively. OnabotA was consistently well tolerated. Increases in I-QOL total scores compared to BL were consistently >2 times the minimally important difference for I-QOL (+11 points; range of +24.5 to +33.5 across treatment cycles 1-8; onabotA 200U). Results were similar for onabotA 300U (which some pts received before all were switched to 200U). CONCLUSIONS Clinically meaningful and sustained improvements in UI and QOL were observed over 4 years of repeat onabotA treatment in pts with UI due to NDO. Approximately one-third of completed onabotA 200U treatment cycles lasted ≥48 weeks. © 2014FiguresReferencesRelatedDetailsCited byRovner E, Kohan A, Chartier-Kastler E, Jünemann K, Del Popolo G, Herschorn S, Joshi M, Magyar A and Nitti V (2018) Long-Term Efficacy and Safety of OnabotulinumtoxinA in Patients with Neurogenic Detrusor Overactivity Who Completed 4 Years of TreatmentJournal of Urology, VOL. 196, NO. 3, (801-808), Online publication date: 1-Sep-2016. Volume 191Issue 4SApril 2014Page: e942 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Michael Kennelly More articles by this author Roger Dmochowski More articles by this author Heinrich Schulte-Baukloh More articles by this author Karen Ethans More articles by this author Brenda Jenkins More articles by this author Steven Guard More articles by this author Ho-Jin Lee More articles by this author Gilles Karsenty More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...