title: Improved quality of life in patients with overactive bladder symptoms treated with solifenacin.
abstract: OBJECTIVE
  To assess the effect of solifenacin succinate treatment on quality of life (QoL) measured in clinical trials in patients with overactive bladder (OAB).
  
  
  METHODS
  QoL data using the King's Health Questionnaire (KHQ) were analysed from two phase-3, 12-week studies (1984 patients) and a long-term extension of these studies (1637 patients) where patients received solifenacin for up to an additional 40 weeks (i.e. a 52-week exposure to solifenacin). The 12-week studies were multinational, multicentre, randomized, double-blind, and placebo-controlled. The 10 domains from the KHQ evaluated were general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, severity measures, and symptom severity. Changes from baseline to endpoint in QoL variables were assessed by analysis of variance, and from pooled outcomes of the 12-week studies by analysis of covariance. Descriptive statistics were used to evaluate data in the extension study.
  
  
  RESULTS
  In the two 12-week studies (1033 and 857 patients), those receiving once-daily solifenacin had statistically significantly better QoL than those on placebo. Changes in the KHQ were statistically significantly (P < 0.05) different from placebo for both solifenacin 5 and 10 mg once daily on five of the 10 KHQ domains in each of the studies. Pooled data from the two 12-week studies showed statistically significant (P < 0.05) differences from placebo for both solifenacin doses in nine of the 10 domains. Improvements in QoL scores for solifenacin were 35-48% in nine of the 10 domains for the 1347 patients providing QoL data in the extension study. About two-thirds of this overall improvement occurred during the original 12-week study, with an additional third reported during the extension, with an improvement in QoL over time in patients treated with solifenacin.
  
  
  CONCLUSIONS
  Results from the KHQ in study participants in the two double-blind studies showed that solifenacin significantly improved the QoL in patients with OAB symptoms after 12 weeks of treatment, with further improvements during long-term administration up to 1 year. Clinical trial outcomes show a favourable balance of efficacy and tolerability with solifenacin; the present report further supports this efficacy and tolerability by providing evidence for both short- and long-term improvements in QoL.
authors.affiliation: Guy's and St. Thomas' Hospital, London, UK. Con.Kelleher@gstt.sthames.nhs.uk
authors.forename: Con J
authors.initials: CJ
authors.lastname: Kelleher
authors.forename: Linda
authors.initials: L
authors.lastname: Cardozo
authors.forename: Christopher R
authors.initials: CR
authors.lastname: Chapple
authors.forename: Francois
authors.initials: F
authors.lastname: Haab
authors.forename: Arwin M
authors.initials: AM
authors.lastname: Ridder
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007398:Interpersonal Relations; D008297:Male; D015337:Multicenter Studies as Topic; D018727:Muscarinic Antagonists / Q000627:therapeutic use*; D011788:Quality of Life; D011812:Quinuclidines / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D000069464:Solifenacin Succinate; D044005:Tetrahydroisoquinolines / Q000627:therapeutic use*; D016896:Treatment Outcome; D001745:Urinary Bladder Diseases / Q000188:drug therapy*; D014549:Urinary Incontinence / Q000188:drug therapy*
chemical_list: D018727:Muscarinic Antagonists; D011812:Quinuclidines; D044005:Tetrahydroisoquinolines; D000069464:Solifenacin Succinate