title: Efficacy of solifenacin on nocturia in Japanese patients with overactive bladder: impact on sleep evaluated by bladder diary.
abstract: OBJECTIVE
  We compared changes in nocturia and sleep related parameters between the anticholinergic solifenacin and placebo in patients with overactive bladder associated with nocturia.
  
  
  METHODS
  We performed subgroup analysis of data from a randomized, controlled trial of solifenacin (5 or 10 mg) in Japan. Men and women 20 years old or older with overactive bladder were eligible for study participation. Patients who voided at least once during the night at baseline and who completed efficacy and quality of life assessment at baseline and 12 weeks (treatment end) were included in analysis. We compared placebo with the posttreatment change in nocturia and daytime frequency, volume voided per micturition, sleeping time, hours of undisturbed sleep and sleep related quality of life.
  
  
  RESULTS
  Subgroup analysis included 962 patients. Solifenacin 10 mg significantly decreased nocturia episodes by 0.46 episodes (p = 0.0449). Solifenacin 5 and 10 mg significantly increased nighttime volume voided per micturition by 30 and 41 ml (p = 0.0033 and <0.0001, respectively). Compared with placebo (33 minutes) the hours of undisturbed sleep significantly increased by 59 and 60 minutes (p = 0.0196 and 0.0195) in patients with solifenacin 5 and 10 mg, respectively. Significant improvement was observed in sleep related quality of life for solifenacin 5 and 10 mg (each p <0.001). Results must be interpreted with caution due to the exploratory nature of this analysis.
  
  
  CONCLUSIONS
  Solifenacin 10 mg decreases nocturia episodes. Solifenacin 5 and 10 mg increases nighttime volume voided per micturition and may improve quality of sleep and sleep related quality of life in patients with overactive bladder.
authors.affiliation: Department of Urology, Faculty of Medical Sciences, University of Fukui, Fukui, Japan. oyoko@u-fukui.ac.jp
authors.forename: Osamu
authors.initials: O
authors.lastname: Yokoyama
authors.forename: Osamu
authors.initials: O
authors.lastname: Yamaguchi
authors.forename: Hidehiro
authors.initials: H
authors.lastname: Kakizaki
authors.forename: Naoki
authors.initials: N
authors.lastname: Itoh
authors.forename: Takashi
authors.initials: T
authors.lastname: Yokota
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Okada
authors.forename: Osamu
authors.initials: O
authors.lastname: Ishizuka
authors.forename: Seiichiro
authors.initials: S
authors.lastname: Ozono
authors.forename: Momokazu
authors.initials: M
authors.lastname: Gotoh
authors.forename: Takahide
authors.initials: T
authors.lastname: Sugiyama
authors.forename: Narihito
authors.initials: N
authors.lastname: Seki
authors.forename: Masaki
authors.initials: M
authors.lastname: Yoshida
authors.forename: Shunsuke
authors.initials: S
authors.lastname: Yamada
mesh_terms: D000368:Aged; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008499:Medical Records; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000627:therapeutic use*; D053158:Nocturia / Q000188:drug therapy* / Q000209:etiology; D011812:Quinuclidines / Q000627:therapeutic use*; D012890:Sleep; D000069464:Solifenacin Succinate; D044005:Tetrahydroisoquinolines / Q000627:therapeutic use*; D053201:Urinary Bladder, Overactive / Q000150:complications / Q000188:drug therapy*
chemical_list: D018727:Muscarinic Antagonists; D011812:Quinuclidines; D044005:Tetrahydroisoquinolines; D000069464:Solifenacin Succinate