PI-04 DURABLE REDUCTIONS IN URINARY INCONTINENCE WITH LONG-TERM ONABOTULINUMTOXINA TREATMENT IN PATIENTS WITH OVERACTIVE BLADDER SYNDROME: FINAL RESULTS OF 3.5-YEAR STUDY

Abstract

You have accessJournal of UrologyPlenary Session I - Best Abstracts1 Apr 2015PI-04 DURABLE REDUCTIONS IN URINARY INCONTINENCE WITH LONG-TERM ONABOTULINUMTOXINA TREATMENT IN PATIENTS WITH OVERACTIVE BLADDER SYNDROME: FINAL RESULTS OF 3.5-YEAR STUDY Victor Nitti, Dirk De Ridder, David Sussman, Peter Sand, Karl-Dietrich Sievert, Christopher Chapple, Brenda Jenkins, Yan Zheng, and Sidney Radomski Victor NittiVictor Nitti More articles by this author , Dirk De RidderDirk De Ridder More articles by this author , David SussmanDavid Sussman More articles by this author , Peter SandPeter Sand More articles by this author , Karl-Dietrich SievertKarl-Dietrich Sievert More articles by this author , Christopher ChappleChristopher Chapple More articles by this author , Brenda JenkinsBrenda Jenkins More articles by this author , Yan ZhengYan Zheng More articles by this author , and Sidney RadomskiSidney Radomski More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.2932AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Here we present final results of a multicenter, extension study which evaluated long-term efficacy and safety of repeated treatment with onabotulinumtoxinA (onabotA) 100U (up to 3.5 years) in patients (pts) with overactive bladder syndrome (OAB). METHODS Following completion of either of two 24-week, randomized, phase 3 trials, pts were eligible to enter a 3-year extension study in which they could receive multiple intradetrusor onabotA treatments. Pts were treated ‘as needed’ based on their request and fulfillment of prespecified qualification criteria. Data were assessed for the discrete subpopulations of pts who needed exactly 1 (n=105), 2 (n=118), 3 (n=117), 4 (n=83), 5 (n=46), or 6 (n=33) onabotA (100U) treatments during study participation in order to evaluate consistency of response to repeated treatments. Assessments included mean change in UI episodes/day (co-primary endpoint) at week 12 after treatment, proportion of pts with an overall median time to request retreatment (duration of effect) of ≤6 months, 6-12 months, and >12 months, and adverse events (AEs). RESULTS Of the 543 pts who received onabotA 100U, 51.2% completed the study. Discontinuations due to AEs/lack of efficacy were low (5.3/2.8%); the most common reasons for discontinuation were not treatment-related (e.g. personal reasons, study burden, site closure, etc). Baseline mean UI episodes/day were 4.5, 5.0, 5.8, 5.9, 5.2, and 5.7 in the subgroups of pts who needed 1, 2, 3, 4, 5, and 6 onabotA (100U) treatments during the study. Mean reductions in UI episodes/day at week 12 after each treatment were consistent in all subgroups, irrespective of the number of treatments needed; ranges for subgroups who received 1, 2, 3, 4, 5, and 6 treatments were: -3.1; -2.9 to -3.2; -4.1 to -4.5; -3.4 to -3.8; -3.0 to -3.6; and -3.1 to -4.1. As expected, pts who received fewer treatments had longer duration of effect than pts who received more treatments. The median time to request re-treatment was ≤6 months for 34.2%, 6-12 months for 37.2%, and >12 months for 28.5% of pts; overall median duration of effect was 7.6 months. Urinary tract infection was the most common AE observed, with no changes in safety profile observed over time. CONCLUSIONS Long-term treatment with onabotA (100U) resulted in consistent reductions in daily UI episodes, with a median duration of effect >6 months in ∼2/3 of pts and >12 months in almost 1/3 of patients. No increases in AE rates were observed with repeated treatment. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e719-e720 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Victor Nitti More articles by this author Dirk De Ridder More articles by this author David Sussman More articles by this author Peter Sand More articles by this author Karl-Dietrich Sievert More articles by this author Christopher Chapple More articles by this author Brenda Jenkins More articles by this author Yan Zheng More articles by this author Sidney Radomski More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...