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• W2331189781 abstract "No AccessJournal of UrologyAdult Urology1 Sep 2016Mirabegron as Add-On Treatment to Solifenacin in Patients with Incontinent Overactive Bladder and an Inadequate Response to Solifenacin Monotherapyis corrected byErratum Scott MacDiarmid, Salman Al-Shukri, Jack Barkin, Aino Fianu-Jonasson, Philippe Grise, Sender Herschorn, Tahir Saleem, Moses Huang, Emad Siddiqui, Matthias Stölzel, Claire Hemsted, Jameel Nazir, Zalmai Hakimi, Marcus J. Drake, and BESIDE Investigators Scott MacDiarmidScott MacDiarmid Alliance Urology Specialists, Greensboro, North Carolina More articles by this author , Salman Al-ShukriSalman Al-Shukri Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russia More articles by this author , Jack BarkinJack Barkin Humber River Hospital, University of Toronto, Toronto, Ontario, Canada More articles by this author , Aino Fianu-JonassonAino Fianu-Jonasson Karolinska University Hospital, Huddinge, Stockholm, Sweden More articles by this author , Philippe GrisePhilippe Grise Rouen University Hospital, Rouen, France More articles by this author , Sender HerschornSender Herschorn Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada More articles by this author , Tahir SaleemTahir Saleem Astellas Pharma Europe Ltd., Chertsey, Surrey More articles by this author , Moses HuangMoses Huang Astellas Pharma Europe Ltd., Chertsey, Surrey Financial interest and/or other relationship with Astellas. More articles by this author , Emad SiddiquiEmad Siddiqui Astellas Pharma Europe Ltd., Chertsey, Surrey Financial interest and/or other relationship with Astellas. More articles by this author , Matthias StölzelMatthias Stölzel Astellas Pharma Global Development, Leiden, The Netherlands Financial interest and/or other relationship with Astellas. More articles by this author , Claire HemstedClaire Hemsted Astellas Pharma Europe Ltd., Chertsey, Surrey Financial interest and/or other relationship with Astellas. More articles by this author , Jameel NazirJameel Nazir Astellas Pharma Europe Ltd., Chertsey, Surrey Financial interest and/or other relationship with Astellas. More articles by this author , Zalmai HakimiZalmai Hakimi Astellas Pharma Europe Ltd., Chertsey, Surrey Financial interest and/or other relationship with Astellas. More articles by this author , Marcus J. DrakeMarcus J. Drake University of Bristol and Bristol Urological Institute, Bristol, United Kingdom Financial interest and/or other relationship with Astellas. More articles by this author , and BESIDE Investigators More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.03.174AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We investigated improvements in overactive bladder and patient reported outcomes in patients with overactive bladder and refractory incontinence treated with mirabegron 50 mg plus solifenacin 5 mg vs solifenacin 5 or 10 mg. Materials and Methods: Patients with overactive bladder who were incontinent despite 4 weeks of single-blind daily solifenacin 5 mg were randomized 1:1:1 to a double-blind daily combination of mirabegron 50 mg/solifenacin 5 mg, or solifenacin 5 or 10 mg for 12 weeks. The mirabegron dose was increased from 25 to 50 mg after week 4. Symptom bother, health related quality of life and patient perception of bladder condition were assessed by OAB-q (Overactive Bladder Questionnaire) and the PPBC (Patient Perception of Bladder Condition) questionnaire, respectively. Responder rates were based on a 50% reduction in daily incontinence, zero incontinence episodes and fewer than 8 micturitions per 24 hours with minimal important differences in OAB-q and PPBC. Results: Overall 2,174 patients with a median age of 59 years were randomized, including 727 to the combination, 728 to solifenacin 5 mg and 719 to solifenacin 10 mg. Symptom bother, total health related quality of life and its subscales (coping, concern and social), and PPBC were significantly improved with combination vs solifenacin monotherapy (p <0.05). The odds of achieving clinically meaningful improvements in incontinence, micturition frequency, symptom bother, health related quality of life and PPBC were significantly higher for combination than solifenacin monotherapy. The odds of becoming continent was 47% and 28% higher for combination vs solifenacin 5 and 10 mg (OR 1.47, 95% CI 1.17–1.84, p = 0.001 and OR 1.28; 95% CI 1.02–1.61, p = 0.033, respectively). Conclusions: Significantly more patients on the combination achieved clinically meaningful improvements in incontinence and micturition frequency. Improvements were accompanied by similar improvements in PPBC, symptom bother and health related quality of life. References 1 : The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn2002; 21: 167. Google Scholar 2 : Do we need a new definition of the overactive bladder syndrome? ICI-RS 2013. 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Google Scholar 15 : Percutaneous tibial nerve stimulation (PTNS) efficacy in the treatment of lower urinary tract dysfunctions: a systematic review. BMC Urol2013; 13: 61. Google Scholar 16 : Efficacy and adverse events of sacral nerve stimulation for overactive bladder: a systematic review. Neurourol Urodyn2010; 29: S18. Google Scholar 17 : Efficacy and safety of mirabegron add-on therapy to solifenacin in incontinent overactive bladder patients with an inadequate response to initial 4-week solifenacin monotherapy: a randomised, double-blind, multicentre, phase 3b study. Eur Urol2016; 10.1016/j.eururo.2016.02.030. Crossref, Google Scholar 18 : Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: the OAB-q. Qual Life Res2002; 11: 563. Google Scholar 19 : The responsiveness of the Overactive Bladder Questionnaire (OAB-q). Qual Life Res2005; 14: 849. 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Eur Urol2015; 67: 577. Google Scholar 26 : Results of a randomized phase III trial of mirabegron in patients with overactive bladder. J Urol2013; 189: 1388. Link, Google Scholar 27 : Efficacy and tolerability of mirabegron, a β(3)-adrenoceptor agonist, in patients with overactive bladder: results from a randomised European-Australian phase 3 trial. Eur Urol2013; 63: 283. Google Scholar 28 : A phase III, randomized, double-blind, parallel-group, placebo-controlled, multicentre study to assess the efficacy and safety of the β₃ adrenoceptor agonist, mirabegron, in patients with symptoms of overactive bladder. Urology2013; 82: 313. Google Scholar 29 : The effect of mirabegron on patient-related outcomes in patients with overactive bladder: the results of post hoc correlation and responder analyses using pooled data from three randomized Phase III trials. Qual Life Res2015; 24: 1719. Google Scholar 30 Abrams P, Kelleher C, Staskin D et al: Combination treatment with mirabegron and solifenacin in patients with overactive bladder: exploratory responder analyses of efficacy and evaluation of patient reported outcomes from a randomised, double-blind, dose-ranging, phase II study (Symphony). Presented at Congress of Société Internationale d’Urologie, Glasgow, Scotland, October 12-15, 2014. Google Scholar © 2016 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byWein A (2020) Re: Efficacy and Safety of Combination Pharmacotherapy for Patients with Overactive Bladder: A Rapid Evidence AssessmentJournal of Urology, VOL. 204, NO. 6, (1388-1389), Online publication date: 1-Dec-2020.Seftel A (2018) Re: The Effect of Mirabegron, Used for Overactive Bladder Treatment, on Female Sexual Function: A Prospective Controlled StudyJournal of Urology, VOL. 200, NO. 5, (927-929), Online publication date: 1-Nov-2018.Seftel A (2018) Re: OnabotulinumtoxinA Detrusor Injection Improves Female Sexual Function in Women with Overactive Bladder Wet SyndromeJournal of Urology, VOL. 200, NO. 5, (927-928), Online publication date: 1-Nov-2018.Related articlesJournal of Urology7 Oct 2016Erratum Volume 196Issue 3September 2016Page: 809-818Supplementary Materials Advertisement Copyright & Permissions© 2016 by American Urological Association Education and Research, Inc.Keywordsquality of lifemirabegronurinary incontinenceurinary bladder, overactivesolifenacin succinateAcknowledgmentsStuart Murray and Dr. Paul Lane, Envision Scientific Solutions, prepared the manuscript.MetricsAuthor Information Scott MacDiarmid Alliance Urology Specialists, Greensboro, North Carolina More articles by this author Salman Al-Shukri Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russia More articles by this author Jack Barkin Humber River Hospital, University of Toronto, Toronto, Ontario, Canada More articles by this author Aino Fianu-Jonasson Karolinska University Hospital, Huddinge, Stockholm, Sweden More articles by this author Philippe Grise Rouen University Hospital, Rouen, France More articles by this author Sender Herschorn Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada More articles by this author Tahir Saleem Astellas Pharma Europe Ltd., Chertsey, Surrey More articles by this author Moses Huang Astellas Pharma Europe Ltd., Chertsey, Surrey Financial interest and/or other relationship with Astellas. More articles by this author Emad Siddiqui Astellas Pharma Europe Ltd., Chertsey, Surrey Financial interest and/or other relationship with Astellas. More articles by this author Matthias Stölzel Astellas Pharma Global Development, Leiden, The Netherlands Financial interest and/or other relationship with Astellas. More articles by this author Claire Hemsted Astellas Pharma Europe Ltd., Chertsey, Surrey Financial interest and/or other relationship with Astellas. More articles by this author Jameel Nazir Astellas Pharma Europe Ltd., Chertsey, Surrey Financial interest and/or other relationship with Astellas. More articles by this author Zalmai Hakimi Astellas Pharma Europe Ltd., Chertsey, Surrey Financial interest and/or other relationship with Astellas. More articles by this author Marcus J. Drake University of Bristol and Bristol Urological Institute, Bristol, United Kingdom Financial interest and/or other relationship with Astellas. More articles by this author BESIDE Investigators More articles by this author Expand All Advertisement PDF downloadLoading ..." @default.
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