title: Add-on anticholinergic therapy for residual nocturia in patients with lower urinary tract symptoms receiving α1-blocker treatment: a multi-centre, prospective, randomised study.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of imidafenacin (IM), a novel short half-life anticholinergic, as add-on therapy for male LUTS with nocturia and nocturnal polyuria.
  
  
  METHODS
  This multicenter, prospective, randomized, open-labelled study was conducted and involved men who had frequency, urgency, and nocturia despite receiving a stable dose of α1-blocker for ≥1 month. Subjects were randomised to control (α1-blocker alone), IM twice/day (α1-blocker +0.1 mg imidafenacin twice daily), or IM nightly (α1-blocker plus 0.1 mg imidafenacin nightly) group; the treatment period was 8 weeks. Primary endpoints included improvements in night-time frequency and Nocturia Quality of Life Questionnaire (N-QOL) scores. Secondary endpoints included changes from the baseline in frequency volume chart variables, and post-void residual volume.
  
  
  CONCLUSIONS
  Compared with the controls, IM twice/day and IM nightly patients had a significantly lower night-time frequency (changes from baseline: 0.1 ± 0.8 in control, -0.6 ± 0.9 in IM twice/day, and -0.4 ± 1.0 in IM nightly, p = 0.5227, 0.0006 and 0.0143, respectively). The hours of undisturbed sleep and N-QOL score were significantly improved in IM twice/day group, though not IM nightly group. Nocturnal urine volume was significantly reduced in IM nightly group, although total urine volume remained unchanged.
  
  
  CONCLUSIONS
  A short half-life anticholinergic is suggested to be safe and effective as an add-on therapy for residual nocturia in patients with male LUTS receiving α1-blocker treatment. Anticholinergic administration nightly could reduce the nocturnal urine volume.
authors.affiliation: Department of Urology, Faculty of Medical Science, University of Fukui, Fukui, Japan, oyoko@u-fukui.ac.jp.
authors.forename: Osamu
authors.initials: O
authors.lastname: Yokoyama
authors.forename: Akira
authors.initials: A
authors.lastname: Tsujimura
authors.forename: Hironobu
authors.initials: H
authors.lastname: Akino
authors.forename: Naoki
authors.initials: N
authors.lastname: Segawa
authors.forename: Satoshi
authors.initials: S
authors.lastname: Tamada
authors.forename: Naoki
authors.initials: N
authors.lastname: Oguchi
authors.forename: Yasuhide
authors.initials: Y
authors.lastname: Kitagawa
authors.forename: Hidenori
authors.initials: H
authors.lastname: Tsuji
authors.forename: Akihiko
authors.initials: A
authors.lastname: Watanabe
authors.forename: Teruo
authors.initials: T
authors.lastname: Inamoto
authors.forename: Nobutaka
authors.initials: N
authors.lastname: Shimizu
authors.forename: Yasuyoshi
authors.initials: Y
authors.lastname: Fujiuchi
authors.forename: Yoji
authors.initials: Y
authors.lastname: Katsuoka
authors.forename: Haruhito
authors.initials: H
authors.lastname: Azuma
authors.forename: Tadashi
authors.initials: T
authors.lastname: Matsuda
authors.forename: Mikio
authors.initials: M
authors.lastname: Namiki
authors.forename: Hirotsugu
authors.initials: H
authors.lastname: Uemura
authors.forename: Akihiko
authors.initials: A
authors.lastname: Okuyama
authors.forename: Norio
authors.initials: N
authors.lastname: Nonomura
authors.forename: Hideki
authors.initials: H
authors.lastname: Fuse
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Nakatani
mesh_terms: D058668:Adrenergic alpha-1 Receptor Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D000368:Aged; D000369:Aged, 80 and over; D018680:Cholinergic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D006207:Half-Life; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D015994:Incidence; D007564:Japan; D059411:Lower Urinary Tract Symptoms / Q000150:complications*; D008297:Male; D053158:Nocturia / Q000188:drug therapy* / Q000209:etiology*; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D058668:Adrenergic alpha-1 Receptor Antagonists; D018680:Cholinergic Antagonists; D007093:Imidazoles; C120953:imidafenacin