MP76-13 URINARY RETENTION IN PATIENTS WITH OVERACTIVE BLADDER TREATED WITH MIRABEGRON ALONE AND IN COMBINATION WITH SOLIFENACIN: THE RESULTS OF TWO RANDOMIZED, DOUBLE-BLIND, PHASE II STUDIES

Abstract

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Non-neurogenic Voiding Dysfunction1 Apr 2014MP76-13 URINARY RETENTION IN PATIENTS WITH OVERACTIVE BLADDER TREATED WITH MIRABEGRON ALONE AND IN COMBINATION WITH SOLIFENACIN: THE RESULTS OF TWO RANDOMIZED, DOUBLE-BLIND, PHASE II STUDIES Victor Nitti, Paul Abrams, David Staskin, Stephen Auerbach, Reynaldo Martina, and Robert van Maanen Victor NittiVictor Nitti More articles by this author , Paul AbramsPaul Abrams More articles by this author , David StaskinDavid Staskin More articles by this author , Stephen AuerbachStephen Auerbach More articles by this author , Reynaldo MartinaReynaldo Martina More articles by this author , and Robert van MaanenRobert van Maanen More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.2406AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The introduction of the [beta]3-adrenoceptor agonist, mirabegron (MIRA), to treat overactive bladder (OAB), and its combination with an antimuscarinic (solifenacin [SOLI]) to potentially augment efficacy, may have safety implications, particularly in patients at higher risk of urinary retention (eg. males with bladder outlet obstruction [BOO]). The incidence of urinary retention and increased post voiding residual (PVR) volume, a predictor of urinary retention risk, are reported in two phase II studies: MIRA/SOLI combination therapy (NCT01340027 [Study 1]) and MIRA monotherapy in male patients with lower urinary tract symptoms (LUTS) and BOO (NCT00410514 [Study 2]). METHODS Study 1: 439 male and 867 female patients aged ≥18 years with symptoms of OAB for ≥3 months and PVR volume <150 mL were randomized to 1 of 12 treatment groups for 12 weeks: 6 combination groups SOLI (2.5, 5 or 10 mg) + MIRA (25 or 50 mg); 5 monotherapy groups SOLI (2.5, 5 or 10 mg) or MIRA (25 or 50 mg); or placebo. Study 2: 200 male patients with LUTS and BOO (International Prostate Symptom Score ≥8, Bladder Outlet Obstruction Index ≥20) aged ≥45 years were randomized 1:1:1 to MIRA 50 mg or 100 mg, or placebo for 12 weeks. In both studies the incidence of urinary retention was assessed using a predefined MedDRA query, and residual urine volume according to the change from baseline to end of treatment (EoT) in PVR volume. RESULTS Study 1: Urinary retention was reported for 2/1306 (0.2%) patients, of which one case, receiving the 2.5 + 25 mg combination, was considered to be acute urinary retention. Another 6/1306 (0.5%) patients had the preferred term of residual urine volume increased. Mean change from baseline to EoT in PVR volume was similar across all treatment groups although a dose response effect could not be excluded in the combination groups (Table). Study 2: Urinary retention was absent in all treatment groups except placebo (n=1) and MIRA 100 mg (n=1; Table). The increase in PVR volume at EoT was not statistically significant in the MIRA 50 mg group. CONCLUSIONS MIRA as monotherapy in male patients with LUTS and BOO, and in combination with SOLI in OAB patients, did not appear to increase the risk of urinary retention. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e886-e887 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Victor Nitti More articles by this author Paul Abrams More articles by this author David Staskin More articles by this author Stephen Auerbach More articles by this author Reynaldo Martina More articles by this author Robert van Maanen More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...