MP76-12 OVERACTIVE BLADDER PATIENTS ≥65 YEARS OF AGE HAVE A SIMILAR EFFICACY AND SAFETY PROFILE WITH ONABOTULINUMTOXINA AS PATIENTS

Abstract

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Non-neurogenic Voiding Dysfunction1 Apr 2014MP76-12 OVERACTIVE BLADDER PATIENTS ≥65 YEARS OF AGE HAVE A SIMILAR EFFICACY AND SAFETY PROFILE WITH ONABOTULINUMTOXINA AS PATIENTS <65 YEARS OF AGE Courtenay Moore, Albert Kaufmann, Manher Joshi, Christopher Nardo, Yan Zheng, and Sender Herschorn Courtenay MooreCourtenay Moore More articles by this author , Albert KaufmannAlbert Kaufmann More articles by this author , Manher JoshiManher Joshi More articles by this author , Christopher NardoChristopher Nardo More articles by this author , Yan ZhengYan Zheng More articles by this author , and Sender HerschornSender Herschorn More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.2405AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Two phase 3, randomized trials have shown that onabotulinumtoxinA (onabotA) 100U is effective and well-tolerated in patients with overactive bladder (OAB) who were inadequately managed with an anticholinergic. As the prevalence of OAB increases with age, we examined efficacy and safety in patients <65 and ≥65 years (y) of age. METHODS Data from the two phase 3 trials, in which patients received intradetrusor injections of 100U onabotA or placebo, were pooled for analysis. The following endpoints were evaluated in patients <65 and ≥65 y of age: change from baseline at week (wk) 12 in daily urinary incontinence (UI) episodes; proportion of patients with a positive treatment response on the Treatment Benefit Scale (TBS); proportion of patients with postvoid residual urine volume (PVR) ≥200mL; proportion of patients reporting clean intermittent catheterization (CIC); and adverse events (AEs). RESULTS Patients <65 y (placebo=323, onabotA=312) and ≥65 y (placebo=225, onabotA=245) had similar baseline characteristics. In younger vs older patients, baseline UI episodes were 5.0 and 6.1 UI episodes/day, respectively, and baseline PVR was 18.9 mL and 23.6 mL, respectively; no patients were performing CIC. At wk 12, reductions in daily UI episodes with onabotA were greater than placebo in patients <65 y (-2.6 vs -1.0; p<0.001) and in those ≥65 y (-3.1 vs -0.9; p<0.001). The percentage of patients with a positive TBS response was also greater with onabotA than placebo in patients <65 y (61.7% vs 30.6%; p<0.001) and ≥65 y (61.8% vs 24.2%; p<0.001). The proportion of patients with PVR ≥200 mL was greater after onabotA than placebo in both age groups (<65 y: 9.0% vs 0.6%; p<0.001; ≥65 y:12.9% vs 1.3%; p<0.001), as was the proportion of patients using CIC (<65 y: 5.4% vs 0.3%; ≥65 y: 7.9% vs 0.4%). Urinary tract infections (UTI) were more common in patients ≥65 y in both onabotA and placebo groups (onabotA 32.9%, placebo 15.2%) compared with those <65 y (onabotA 19.9%, placebo 5.7%). Otherwise, there were no overall differences in the safety profile following onabotA treatment between older and younger patients in these studies. CONCLUSIONS OnabotA 100U provided similar and clinically meaningful efficacy in patients regardless of age, significantly reducing daily UI episodes and providing treatment benefit. Although UTI appeared to be more frequent in older patients for both placebo and onabotA groups, overall there were no relevant differences in the safety profile among the patient age groups. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e886 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Courtenay Moore More articles by this author Albert Kaufmann More articles by this author Manher Joshi More articles by this author Christopher Nardo More articles by this author Yan Zheng More articles by this author Sender Herschorn More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...