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Open Access 01-05-2015 | Original Article

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

Authors: Osamu 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

Published in: World Journal of Urology | Issue 5/2015

Abstract

Purpose

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.

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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
Authors: Osamu 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
Publication date: 01-05-2015
Publisher: Springer Berlin Heidelberg
Published in: World Journal of Urology / Issue 5/2015
Print ISSN: 0724-4983
Electronic ISSN: 1433-8726
DOI: https://doi.org/10.1007/s00345-014-1399-x

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Purpose

Materials and methods

Results and limitations

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Purpose

Materials and methods

Results and limitations

Conclusions

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