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Add-on anticholinergic therapy for residual nocturia in patients with lower urinary tract symptoms receiving α1-blocker treatment: a multi-centre, prospective, randomised study.

AbstractPURPOSE:
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.
MATERIALS AND 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.
RESULTS AND LIMITATIONS:
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.
AuthorsOsamu Yokoyama, Akira Tsujimura, Hironobu Akino, Naoki Segawa, Satoshi Tamada, Naoki Oguchi, Yasuhide Kitagawa, Hidenori Tsuji, Akihiko Watanabe, Teruo Inamoto, Nobutaka Shimizu, Yasuyoshi Fujiuchi, Yoji Katsuoka, Haruhito Azuma, Tadashi Matsuda, Mikio Namiki, Hirotsugu Uemura, Akihiko Okuyama, Norio Nonomura, Hideki Fuse, Tatsuya Nakatani
JournalWorld journal of urology (World J Urol) Vol. 33 Issue 5 Pg. 659-67 (May 2015) ISSN: 1433-8726 [Electronic] Germany
PMID25224929 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Adrenergic alpha-1 Receptor Antagonists
  • Cholinergic Antagonists
  • Imidazoles
  • imidafenacin
Topics
  • Adrenergic alpha-1 Receptor Antagonists (adverse effects, therapeutic use)
  • Aged
  • Aged, 80 and over
  • Cholinergic Antagonists (adverse effects, therapeutic use)
  • Drug Therapy, Combination
  • Half-Life
  • Humans
  • Imidazoles (adverse effects, therapeutic use)
  • Incidence
  • Japan
  • Lower Urinary Tract Symptoms (complications)
  • Male
  • Nocturia (drug therapy, etiology)
  • Prospective Studies
  • Quality of Life
  • Surveys and Questionnaires
  • Treatment Outcome

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