A Randomized Controlled Study of the Efficacy of Tamsulosin Monotherapy and its Combination with Mirabegron for Overactive Bladder Induced by Benign Prostatic Obstruction

No AccessJournal of UrologyAdult Urology1 Mar 2015A Randomized Controlled Study of the Efficacy of Tamsulosin Monotherapy and its Combination with Mirabegron for Overactive Bladder Induced by Benign Prostatic Obstruction Koji Ichihara, Naoya Masumori, Fumimasa Fukuta, Taiji Tsukamoto, Akihiko Iwasawa, and Yoshinori Tanaka Koji IchiharaKoji Ichihara Department of Urology, Sapporo Medical University School of Medicine, Hokkaido, Japan More articles by this author , Naoya MasumoriNaoya Masumori Department of Urology, Sapporo Medical University School of Medicine, Hokkaido, Japan Financial interest and/or other relationship with Astellas Pharma, Inc. and Daiichi Sankyo Company. More articles by this author , Fumimasa FukutaFumimasa Fukuta Department of Urology, Sapporo Medical University School of Medicine, Hokkaido, Japan More articles by this author , Taiji TsukamotoTaiji Tsukamoto Department of Urology, Sapporo Medical University School of Medicine, Hokkaido, Japan More articles by this author , Akihiko IwasawaAkihiko Iwasawa Iwasawa Clinic, Hokkaido, Japan More articles by this author , and Yoshinori TanakaYoshinori Tanaka Department of Urology, Hokkaido Prefectural Esashi Hospital, Hokkaido, Japan More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.09.091AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We evaluated the efficacy and safety of add-on treatment with a β3-adrenoceptor agonist (mirabegron) for overactive bladder symptoms remaining after α1-blocker (tamsulosin) treatment in men with benign prostatic obstruction. Materials and Methods: Patients with benign prostatic obstruction with urinary urgency at least once per week and a total OABSS of 3 or more points after 8 or more weeks of treatment with tamsulosin were enrolled in the study. They were randomly allocated to receive 0.2 mg tamsulosin daily or 0.2 mg tamsulosin and 50 mg mirabegron daily for 8 weeks. The primary end point was change in total OABSS. Safety assessments included change in post-void residual urine volume and adverse events. Results: From January 2012 through September 2013 a total of 94 patients were randomized. Of these patients 76 completed the protocol treatment. In the full analysis set the change in total OABSS during the treatment period was significantly greater in the combination group than in the monotherapy group (−2.21 vs −0.87, p=0.012). The changes in scores for urinary urgency, daytime frequency, International Prostate Symptom Score storage symptom subscore and quality of life index at 8 weeks were significantly greater in the combination group. The change in post-void residual urine volume was significantly greater in the combination group. Although 6 patients experienced adverse events in the combination group, urinary retention was observed in only 1 patient. Conclusions: Combined tamsulosin and mirabegron treatment is effective and safe for patients with benign prostatic obstruction who have overactive bladder symptoms after tamsulosin monotherapy. References 1 : EAU guidelines on the treatment and follow-up of non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction. Eur Urol2013; 64: 118. Google Scholar 2 : Comparison of doxazosin with or without tolterodine in men with symptomatic bladder outlet obstruction and an overactive bladder. BJU Int2004; 94: 817. 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Google Scholar © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited ByKaplan S, Herschorn S, McVary K, Staskin D, Chapple C, Foley S, Cambronero Santos J, Kristy R, Choudhury N, Hairston J and Schermer C (2020) Efficacy and Safety of Mirabegron versus Placebo Add-On Therapy in Men with Overactive Bladder Symptoms Receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia: A Randomized, Phase 4 Study (PLUS)Journal of Urology, VOL. 203, NO. 6, (1163-1171), Online publication date: 1-Jun-2020.Kaplan S (2018) Re: Medical Treatment of Nocturia in Men with Lower Urinary Tract Symptoms: Systematic Review by the European Association of Urology Guidelines Panel for Male Lower Urinary Tract SymptomsJournal of Urology, VOL. 199, NO. 4, (868-868), Online publication date: 1-Apr-2018.Griebling T (2018) Re: The Efficacy of Mirabegron Additional Therapy for Lower Urinary Tract Symptoms after Treatment with Α1-Adrenergic Receptor Blocker Monotherapy: Prospective Analysis of Elderly MenJournal of Urology, VOL. 196, NO. 6, (1711-1711), Online publication date: 1-Dec-2016.Steers W (2018) This Month in Adult UrologyJournal of Urology, VOL. 193, NO. 3, (747-748), Online publication date: 1-Mar-2015. Volume 193Issue 3March 2015Page: 921-926 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.Keywordsadrenergic alpha-antagonistsurinary bladderoveractiveadrenergic beta-agonistsprostatic hyperplasiaAcknowledgmentsThe following doctors conducted data collection and completed case report forms: Fumiyasu Takei, Shuichi Kato, Yohei Matsuda Masahiro Matsuki (Sunagawa City Hospital), Keisuke Taguchi, Yuichiro Kurimura, Yoshiki Hiyama (Oji General Hospital), Noriomi Miyao, Ryuichi Kato (Muroran City General Hospital), Yoshikazu Sato, Kazunori Haga (Sanjyukai Hospital), Nobukazu Suzuki, Ken-ichi Sunaoshi (Teine Urological Clinic), Hiroki Horita (Saiseikai Otaru Hospital), Naoki Itoh, Kohei Hashimoto (NTT East Japan Sapporo Hospital), Taketoshi Saka, Seiji Yamazaki (Saka Urological Hospital), Seiji Furuya (Furuya Urological Clinic), Masanori Shigyo (Kushiro Red Cross Hospital), Yasuharu Kunishima (Obihiro Kyokai Hospital), Toshiaki Shimizu (Kamui Yawaragi Urological Clinic), and Hitoshi Tachiki (Steel Memorial Muroran Hospital).MetricsAuthor Information Koji Ichihara Department of Urology, Sapporo Medical University School of Medicine, Hokkaido, Japan More articles by this author Naoya Masumori Department of Urology, Sapporo Medical University School of Medicine, Hokkaido, Japan Financial interest and/or other relationship with Astellas Pharma, Inc. and Daiichi Sankyo Company. More articles by this author Fumimasa Fukuta Department of Urology, Sapporo Medical University School of Medicine, Hokkaido, Japan More articles by this author Taiji Tsukamoto Department of Urology, Sapporo Medical University School of Medicine, Hokkaido, Japan More articles by this author Akihiko Iwasawa Iwasawa Clinic, Hokkaido, Japan More articles by this author Yoshinori Tanaka Department of Urology, Hokkaido Prefectural Esashi Hospital, Hokkaido, Japan More articles by this author Expand All Advertisement PDF DownloadLoading ...