1367 ONABOTULINUMTOXINA IN PATIENTS WITH OVERACTIVE BLADDER AND URINARY INCONTINENCE: CONSISTENT EFFECT OVER REPEAT TREATMENT
2013-03-27

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Incontinence, Evaluation & Therapy (III)1 Apr 20131367 ONABOTULINUMTOXINA IN PATIENTS WITH OVERACTIVE BLADDER AND URINARY INCONTINENCE: CONSISTENT EFFECT OVER REPEAT TREATMENT Victor W. Nitti, Karl-Dietrich Sievert, David Sussman, Sidney B. Radomski, Peter Sand, Catherine Thompson, Christopher Nardo, Jihao Zhou, Denise Globe, Cornelia Haag-Molkenteller, and Christopher Chapple Victor W. NittiVictor W. Nitti New York, NY , Karl-Dietrich SievertKarl-Dietrich Sievert Tuebingen, Germany , David SussmanDavid Sussman Newark, NJ , Sidney B. RadomskiSidney B. Radomski Toronto, Canada , Peter SandPeter Sand Chicago, IL , Catherine ThompsonCatherine Thompson Marlow, United Kingdom , Christopher NardoChristopher Nardo Irvine, CA , Jihao ZhouJihao Zhou Irvine, CA , Denise GlobeDenise Globe Irvine, CA , Cornelia Haag-MolkentellerCornelia Haag-Molkenteller Irvine, CA , and Christopher ChappleChristopher Chapple Sheffield, United Kingdom View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.2721AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES OnabotulinumtoxinA (onabotA) 100U was confirmed to be effective in 2 placebo-controlled pivotal studies for the treatment (tx) of patients (pts) with idiopathic overactive bladder (OAB) syndrome and urinary incontinence (UI) who were inadequately managed with anticholinergic (ACH) therapy. This is the first report of a pre-specified interim analysis of the extension trial, with evaluation of efficacy and safety over repeated onabotA tx. METHODS On completion of the pivotal studies, pts could enter a 3-year extension study and receive multiple tx of intradetrusor onabotA. Data were integrated across studies; pts receiving ≥1 onabotA tx in the evaluation period were analyzed by onabotA tx cycle (up to 5 cycles). Change from baseline (BL; before any tx) at week (wk) 12 in OAB symptoms, proportion of pts with a positive tx response (greatly improved or improved) on the tx benefit scale (TBS), duration of effect (Kaplan-Meier analysis of time to pts' request for re-tx), and health-related quality of life (HRQOL) were assessed. Adverse events (AEs) and use of clean intermittent catheterization (CIC) due to elevated post void residual urine (PVR) were also evaluated. RESULTS A total of 825, 558, 253, 113, and 47 pts received 1, 2, 3, 4, and 5 onabotA 100U tx, respectively, in this ongoing study. UI episodes/day were consistently reduced compared to BL; reductions at wk 12 were −3.25, −3.70, −3.49, −2.79, and −2.55 in onabotA 100U tx cycles 1 through 5. Continued reductions vs BL were also seen in other OAB symptoms over repeated tx cycles. A high proportion of pts reported a positive tx response on TBS during each tx cycle (73.9, 78.9, 77.3, 72.9, and 77.1% at wk 12 in onabotA 100U cycles 1 through 5). A consistent duration of effect was observed; median time to request for re-tx was 24.0, 25.7, and 24.1 wks for cycles 1, 2, and 3 (too few pts had yet requested re-tx in cycles 4 and 5 for an accurate estimate). Large improvements from BL in HRQOL that exceeded the minimally important difference were seen following each onabotA tx. The most common AE in each tx cycle was uncomplicated urinary tract infection (26.9, 24.2, 24.5, 20.4, and 14.9%). The proportion of pts requiring CIC due to elevated PVR was 4.6, 4.1, 4.7, 5.3, and 2.1% in onabotA 100U cycles 1 through 5. No change in the AE profile was observed. CONCLUSIONS Repeated onabotA tx in OAB pts with UI inadequately managed with ACHs showed sustained improvements in OAB symptoms, pt perception of improvement in their condition, and HRQOL. A consistent safety profile was also seen, with no new safety signals. © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e559-e560 Peer Review Report Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information Victor W. Nitti New York, NY More articles by this author Karl-Dietrich Sievert Tuebingen, Germany More articles by this author David Sussman Newark, NJ More articles by this author Sidney B. Radomski Toronto, Canada More articles by this author Peter Sand Chicago, IL More articles by this author Catherine Thompson Marlow, United Kingdom More articles by this author Christopher Nardo Irvine, CA More articles by this author Jihao Zhou Irvine, CA More articles by this author Denise Globe Irvine, CA More articles by this author Cornelia Haag-Molkenteller Irvine, CA More articles by this author Christopher Chapple Sheffield, United Kingdom More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...