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• W4249807744 abstract "No AccessJournal of UrologyAdult Urology1 Dec 2009Safety and Tolerability of Solifenacin Add-on Therapy to α-Blocker Treated Men With Residual Urgency and Frequencyis companion ofSafety and Tolerability of Solifenacin Add-on Therapy to α-Blocker Treated Men With Residual Urgency and Frequency Steven A. Kaplan, Kurt McCammon, Roger Fincher, Allam Fakhoury, and Weizhong He Steven A. KaplanSteven A. Kaplan Weill Medical College of Cornell University, New York, New York Financial interest and/or other relationship with Astellas, Watson, Neotract, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Sanofi-Synthelabo and Pfizer. More articles by this author , Kurt McCammonKurt McCammon Eastern Virginia Medical School, Norfolk, Virginia Financial interest and/or other relationship with AMS, Astellas, and Engineers and Doctors. More articles by this author , Roger FincherRoger Fincher Deaconess Medical Building, Spokane, Washington Nothing to disclose. More articles by this author , Allam FakhouryAllam Fakhoury Astellas Pharma US Inc., Deerfield, Illinois Financial interest and/or other relationship with Astellas. More articles by this author , and Weizhong HeWeizhong He Astellas Pharma US Inc., Deerfield, Illinois Financial interest and/or other relationship with Astellas. More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2009.08.023AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: VICTOR was a 12-week, double-blind, placebo controlled trial assessing the safety and tolerability of solifenacin plus tamsulosin in men with residual overactive bladder symptoms after tamsulosin monotherapy. Efficacy of solifenacin plus tamsulosin vs placebo plus tamsulosin was also evaluated. Materials and Methods: A total of 398 men 45 years old or older were randomized to 12 weeks of solifenacin plus tamsulosin or placebo plus tamsulosin once daily. The study population had 8 or more micturitions per 24 hours and 1 or more urgency episode per 24 hours after taking tamsulosin for 4 or more weeks, a total International Prostate Symptom Score of 13 or greater, a Patient Perception of Bladder Condition score of 3 or greater, a post-void residual of 200 ml or less and a peak flow rate of 5 ml per second or greater. Adverse events were monitored throughout the study. The primary efficacy end point was mean change from baseline to week 12 in micturitions per 24 hours. Secondary measures included mean change in urgency episodes per 24 hours, and changes in Patient Perception of Bladder Condition, Urgency Perception Scale and total International Prostate Symptom Scores. Results: The most frequent adverse events in the solifenacin plus tamsulosin and placebo plus tamsulosin groups were dry mouth (7% and 3%, respectively) and dizziness (3% and 2%, respectively). Of the patients on solifenacin plus tamsulosin 7 (3%) reported retention and 3 required catheterization. No patients on placebo plus tamsulosin reported retention. Patients on solifenacin plus tamsulosin vs placebo plus tamsulosin showed larger reductions in frequency but not of statistical significance (−1.05 vs −0.67, p = 0.135). However, patients on solifenacin plus tamsulosin vs placebo plus tamsulosin did show statistically significant reductions in urgency (−2.18 vs −1.10, p <0.001). Patient reported outcome measures showed no significant between group differences. Conclusions: Solifenacin plus tamsulosin was well tolerated. There was a low incidence of urinary retention requiring catheterization. At week 12 solifenacin plus tamsulosin decreased daily micturitions and urgency episodes. Only urgency reached statistical significance vs placebo plus tamsulosin. References 1 : The standardisation of terminology in lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Urology2003; 61: 37. Google Scholar 2 : A shifted paradigm for the further understanding, evaluation, and treatment of lower urinary tract symptoms in men: focus on the bladder. Eur Urol2006; 49: 651. Google Scholar 3 : Defining the role of overactive bladder treatments in men with lower urinary tract symptoms. Nat Clin Pract Urol2007; 4: 174. Google Scholar 4 : Antimuscarinic therapy in men with lower urinary tract symptoms: what is the evidence?. Curr Urol Rep2006; 7: 462. Google Scholar 5 : BPH with coexisting overactive bladder dysfunction–an everyday urological dilemma. Neurourol Urodyn2001; 20: 237. Google Scholar 6 : The International Continence Society “Benign Prostatic Hyperplasia” Study: the bothersomeness of urinary symptoms. 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Google Scholar © 2009 by American Urological AssociationFiguresReferencesRelatedDetailsCited byIchihara K, Masumori N, Fukuta F, Tsukamoto T, Iwasawa A and Tanaka Y (2018) A Randomized Controlled Study of the Efficacy of Tamsulosin Monotherapy and its Combination with Mirabegron for Overactive Bladder Induced by Benign Prostatic ObstructionJournal of Urology, VOL. 193, NO. 3, (921-926), Online publication date: 1-Mar-2015.Filson C, Hollingsworth J, Clemens J and Wei J (2018) The Efficacy and Safety of Combined Therapy with α-Blockers and Anticholinergics for Men with Benign Prostatic Hyperplasia: A Meta-AnalysisJournal of Urology, VOL. 190, NO. 6, (2153-2160), Online publication date: 1-Dec-2013.Related articlesJournal of Urology10 Nov 2018Safety and Tolerability of Solifenacin Add-on Therapy to α-Blocker Treated Men With Residual Urgency and Frequency Volume 182Issue 6December 2009Page: 2825-2830 Advertisement Copyright & Permissions© 2009 by American Urological AssociationKeywordsurinary bladder, overactiveadrenergic alpha-antagonistsmuscarinic antagonistsMetricsAuthor Information Steven A. Kaplan Weill Medical College of Cornell University, New York, New York Financial interest and/or other relationship with Astellas, Watson, Neotract, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Sanofi-Synthelabo and Pfizer. More articles by this author Kurt McCammon Eastern Virginia Medical School, Norfolk, Virginia Financial interest and/or other relationship with AMS, Astellas, and Engineers and Doctors. More articles by this author Roger Fincher Deaconess Medical Building, Spokane, Washington Nothing to disclose. More articles by this author Allam Fakhoury Astellas Pharma US Inc., Deerfield, Illinois Financial interest and/or other relationship with Astellas. More articles by this author Weizhong He Astellas Pharma US Inc., Deerfield, Illinois Financial interest and/or other relationship with Astellas. More articles by this author Expand All Advertisement PDF downloadLoading ..." @default.
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