Add-on anticholinergic therapy for residual nocturia in patients with lower urinary tract symptoms receiving alpha 1-blocker treatment: a multi-centre, prospective, randomised study

作者：Yokoyama Osamu^*; Tsujimura Akira; Akino Hironobu; Segawa Naoki; Tamada Satoshi; Oguchi Naoki; Kitagawa Yasuhide; Tsuji Hidenori; Watanabe Akihiko; Inamoto Teruo; Shimizu Nobutaka; Fujiuchi Yasuyoshi; Katsuoka Yoji; Azuma Haruhito; Matsuda Tadashi; Namiki Mikio; Uemura Hirotsugu; Okuyama Akihiko; Nonomura Norio; Fuse Hideki; Nakatani Tatsuya

来源：World Journal of Urology, 2015, 33(5): 659-667.

DOI：10.1007/s00345-014-1399-x

• Anticholinergic
• Nocturia
• Nocturnal urine volume
• Overactive bladder
• Benign prostatic hyperplasia
• Imidafenacin

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.
This multicenter, prospective, randomized, open-labelled study was conducted and involved men who had frequency, urgency, and nocturia despite receiving a stable dose of alpha 1-blocker for a parts per thousand yen1 month. Subjects were randomised to control (alpha 1-blocker alone), IM twice/day (alpha 1-blocker +0.1 mg imidafenacin twice daily), or IM nightly (alpha 1-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.
Compared with the controls, IM twice/day and IM nightly patients had a significantly lower night-time frequency (changes from baseline: 0.1 +/- A 0.8 in control, -0.6 +/- A 0.9 in IM twice/day, and -0.4 +/- A 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.
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 alpha 1-blocker treatment. Anticholinergic administration nightly could reduce the nocturnal urine volume.

• 出版日期2015-5