MP38-01 LONG-TERM EFFICACY AND SAFETY OF REPEAT ONABOTULINUMTOXINA TREATMENT IN OVERACTIVE BLADDER SYNDROME AND URINARY INCONTINENCE: THIRD INTERIM ANALYSIS, MEDIAN 2.4 YEAR FOLLOW-UP
2014-03-28

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Incontinence Therapy II1 Apr 2014MP38-01 LONG-TERM EFFICACY AND SAFETY OF REPEAT ONABOTULINUMTOXINA TREATMENT IN OVERACTIVE BLADDER SYNDROME AND URINARY INCONTINENCE: THIRD INTERIM ANALYSIS, MEDIAN 2.4 YEAR FOLLOW-UP Victor Nitti, Christopher Chapple, David Sussman, Sidney Radomski, Peter Sand, Steven Guard, Christopher Nardo, Jihao Zhou, and Karl-Dietrich Sievert Victor NittiVictor Nitti More articles by this author , Christopher ChappleChristopher Chapple More articles by this author , David SussmanDavid Sussman More articles by this author , Sidney RadomskiSidney Radomski More articles by this author , Peter SandPeter Sand More articles by this author , Steven GuardSteven Guard More articles by this author , Christopher NardoChristopher Nardo More articles by this author , Jihao ZhouJihao Zhou More articles by this author , and Karl-Dietrich SievertKarl-Dietrich Sievert More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.1258AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES OnabotulinumtoxinA (onabotA) was shown to significantly improve urinary incontinence (UI) and quality of life (QOL) in patients (pts) with overactive bladder (OAB) syndrome and UI who were inadequately managed with an anticholinergic (ACH) in 2 large placebo-controlled, multicenter, phase 3 trials. Less is known about the long-term efficacy/safety of onabotA for OAB. Here we present this third, pre-specified interim analysis of a large, multicenter extension study of the long-term efficacy/safety of onabotA for OAB. METHODS Pts who completed the phase 3 studies could enter a 3 year (y) extension study to receive multiple intra-detrusor onabotA 100U injections. Data integrated across the phase 3 and extension studies were analyzed by onabotA treatment (tx) cycle (up to 5). Assessments included change from study baseline (BL) at week (wk) 12 in OAB symptoms (including co-primary endpoint of UI episodes), proportion of pts with a positive tx response (greatly improved or improved) on the Tx Benefit Scale (TBS; co-primary endpoint), health-related quality of life (HRQOL), duration of effect, adverse events (AEs), and use of clean intermittent catheterization (CIC). RESULTS A total of 829 pts entered the extension study; 544 pts were followed up for ≥2 y. As of 6/13, median follow-up was 126 wk (2.4 y). Discontinuation rates due to AEs/lack of efficacy were low (4.5%/4.9%). At BL, pts reported a mean of 5.55 UI episodes/day. Reductions in UI episodes/day were consistently observed at wk 12 following repeat onabotA 100U tx: reductions were -3.26, -3.70, -3.87, -3.20, and -3.22 (cycles 1-5, respectively). Other OAB symptoms were also consistently reduced over repeated onabotA tx, and improvements in HRQOL consistently exceeded clinically relevant minimally important differences. High proportions of onabotA-treated pts continued to report positive TBS responses with repeat onabotA (74.0, 80.9, 80.4, 79.4, and 86.1% in cycles 1-5). Median duration of effect was 24.0, 31.6, 27.9, 24.3, and 23.9 wks (cycles 1- 5). Urinary tract infection was the most common AE in each tx cycle (27.5, 26.5, 27.4, 19.9, and 18.2%), and no change in AE profile over time was observed. CIC rates were 4.6, 4.0, 4.3, 4.6, and 2.9% (cycles 1-5). CONCLUSIONS Continued follow-up in this long-term study revealed sustained improvements in OAB symptoms, pt perception of improvement in their condition, and HRQOL, with no new safety signals observed with repeated onabotA 100U tx in OAB pts with UI inadequately managed with an ACH. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e400-e401 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Victor Nitti More articles by this author Christopher Chapple More articles by this author David Sussman More articles by this author Sidney Radomski More articles by this author Peter Sand More articles by this author Steven Guard More articles by this author Christopher Nardo More articles by this author Jihao Zhou More articles by this author Karl-Dietrich Sievert More articles by this author Expand All Advertisement Advertisement PDF DownloadLoading ...