title: The efficacy of mirabegron additional therapy for lower urinary tract symptoms after treatment with α1-adrenergic receptor blocker monotherapy: prospective analysis of elderly men.
abstract: BACKGROUND
  Mirabegron is a β3-adrenoreceptor agonist developed for treatment of overactive bladder (OAB). α1-Adrenergic receptor blockers are effective for lower urinary tract symptoms (LUTS) in male patients. However, the efficacy of mirabegron additional treatment in elderly male patients with persistent male LUTS, especially in OAB after monotherapy with α1-adrenergic blockers, is not fully understood.
  
  
  METHODS
  This study was conducted in male LUTS patients who were ≥ 65 years of age and had persistent OAB symptoms, regardless of whether they took an α1-adrenergic receptor blocker orally. Before and 12 weeks after mirabegron additional therapy (50 mg once daily), we evaluated the efficacy of this treatment using the Overactive Bladder Symptom Score (OABSS) and International Prostate Symptom Score (IPSS), and changes in the maximum flow rate (Qmax) and post-void residual urine volume (PVR). We evaluated patients overall and divided into two groups by age: young-old (from 65 to 74 years old) and old-old (from 75 to 84 years old).
  
  
  RESULTS
  Fifty men were enrolled in this study. Mirabegron additional therapy improved the total OABSS, total IPSS, and IPSS-quality of life (QOL) score. The voided volume (VV) and Qmax improved after treatment in patients overall. However, there was no significant change in PVR. The total OABSS, total IPSS, and IPSS-QOL score significantly improved in both of the young-old and old-old groups. However, a significant increasing of VV was detected in the young-old group. There were no significant differences in the Qmax or PVR in either group.
  
  
  CONCLUSIONS
  Mirabegron additional therapy was effective for male patients whose persistent LUTS and particularly OAB was not controlled with α1-adrenergic receptor blocker monotherapy, and mirabegron did not have negative effects on voiding function. Additionally, mirabegron additional therapy was considered effective regardless of patient age.
  
  
  BACKGROUND
  Trial registration number (TRN) trial registration number (TRN) and date of registration: ISRCTN16759097 in July 8, 2016.
authors.affiliation: Department of Urology, Nagasaki University Graduate School of Biochemical Sciences, 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan.
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Matsuo
authors.affiliation: Department of Urology, Nagasaki University Graduate School of Biochemical Sciences, 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan. int.doc.miya@m3.dion.ne.jp.
authors.forename: Yasuyoshi
authors.initials: Y
authors.lastname: Miyata
authors.affiliation: Department of Urology, Nagasaki University Graduate School of Biochemical Sciences, 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan.
authors.forename: Katsura
authors.initials: K
authors.lastname: Kakoki
authors.affiliation: Department of Urology, Nagasaki University Graduate School of Biochemical Sciences, 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan.
authors.forename: Miki
authors.initials: M
authors.lastname: Yuzuriha
authors.affiliation: Department of Urology, Nagasaki University Graduate School of Biochemical Sciences, 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Asai
authors.affiliation: Department of Urology, Nagasaki University Graduate School of Biochemical Sciences, 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan.
authors.forename: Kojiro
authors.initials: K
authors.lastname: Ohba
authors.affiliation: Department of Urology, Nagasaki University Graduate School of Biochemical Sciences, 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan.
authors.forename: Hideki
authors.initials: H
authors.lastname: Sakai
mesh_terms: D000083:Acetanilides / Q000627:therapeutic use*; D058668:Adrenergic alpha-1 Receptor Antagonists / Q000627:therapeutic use*; D058667:Adrenergic beta-3 Receptor Agonists / Q000627:therapeutic use*; D000368:Aged; D000369:Aged, 80 and over; D004359:Drug Therapy, Combination; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy*; D008297:Male; D011446:Prospective Studies; D013844:Thiazoles / Q000627:therapeutic use*; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive
chemical_list: D000083:Acetanilides; D058668:Adrenergic alpha-1 Receptor Antagonists; D058667:Adrenergic beta-3 Receptor Agonists; D013844:Thiazoles; C520025:mirabegron
keywords: Elderly male; Mirabegron; Overactive bladder; α1-adrenergic blockers