MP76-05 REDUCTION IN URINARY INCONTINENCE AND IMPROVEMENT IN QUALITY OF LIFE WITH ONABOTULINUMTOXINA IN OVERACTIVE BLADDER PATIENTS IS UNAFFECTED BY THE USE OF CLEAN INTERMITTENT CATHETERIZATION OR THE PRESENCE OF URINARY TRACT INFECTION

Abstract

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Non-neurogenic Voiding Dysfunction1 Apr 2014MP76-05 REDUCTION IN URINARY INCONTINENCE AND IMPROVEMENT IN QUALITY OF LIFE WITH ONABOTULINUMTOXINA IN OVERACTIVE BLADDER PATIENTS IS UNAFFECTED BY THE USE OF CLEAN INTERMITTENT CATHETERIZATION OR THE PRESENCE OF URINARY TRACT INFECTION David Sussman, Jennifer Gruenenfelder, Heinrich Schulte-Baukloh, Steven Guard, Yan Zheng, and Karel Everaert David SussmanDavid Sussman More articles by this author , Jennifer GruenenfelderJennifer Gruenenfelder More articles by this author , Heinrich Schulte-BauklohHeinrich Schulte-Baukloh More articles by this author , Steven GuardSteven Guard More articles by this author , Yan ZhengYan Zheng More articles by this author , and Karel EveraertKarel Everaert More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.2398AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES OnabotulinumtoxinA (onabotA) 100U significantly reduced urinary incontinence (UI) and improved quality of life (QOL) in overactive bladder (OAB) patients who were inadequately managed by anticholinergics in two phase 3 trials. An analysis of the pooled phase 3 trials assessed the efficacy and QOL outcomes by the use of clean intermittent catheterization (CIC) and the presence of urinary tract infection (UTI). METHODS OAB patients who were inadequately managed by anticholinergics received 20 cystoscopic intradetrusor injections (0.5 mL/injection) of onabotA 100U (n=557) or placebo (n=548), sparing the trigone. The proportion of patients with a positive response (condition ‘greatly improved’ or ‘improved’) on the treatment benefit scale (TBS), incontinence-quality of life (I-QOL) total score, and King’s Health Questionnaire (KHQ) domains of role limitations, social limitations, physical limitations, and incontinence impact were assessed by CIC use/non-use and UTI status (presence/absence) during the first 12 weeks of treatment. Change from baseline at week 12 in UI episodes/day was assessed by UTI status. Minimally important differences (MIDs, which reflect clinical relevance) were +10 and -5 points for I-QOL and KHQ, respectively. RESULTS CIC use was reported in 44 patients in onabotA group vs 8 in placebo; 99 patients in onabotA vs 30 in placebo had UTI. Regardless of CIC use, the perception of treatment benefit was greater with onabotA vs placebo (63.6% vs 25.0% with CIC; 61.6% vs 28.0% without CIC) and QOL improvements above MID were seen with onabotA vs placebo in I-QOL total score and KHQ role and social limitations, physical limitations and incontinence impact domains. At week 12, regardless of UTI status, onabotA reduced UI episodes/day from baseline vs placebo (-3.01 vs -1.19 episodes/day with UTI; -2.76 vs -0.93 without UTI) and increased the proportion of positive TBS responders vs placebo (52.5% vs 33.3% with UTI, and 63.8% vs 27.6% without UTI). QOL improvements above MID were noted with onabotA vs placebo regardless of UTI status, including improvements in I-QOL total score and all evaluated KHQ domain scores. CONCLUSIONS In OAB patients who were inadequately managed by anticholinergics, the perception of treatment benefit and QOL improvements with onabotA were unaffected by CIC use. In addition, onabotA reduced UI and improved perception of treatment benefit and QOL regardless of UTI status. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e883-e884 Advertisement Copyright & Permissions© 2014MetricsAuthor Information David Sussman More articles by this author Jennifer Gruenenfelder More articles by this author Heinrich Schulte-Baukloh More articles by this author Steven Guard More articles by this author Yan Zheng More articles by this author Karel Everaert More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...