title: Efficacy and tolerability of solifenacin in men with overactive bladder: results of an observational study.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of solifenacin for the treatment of OAB in men.
  
  
  METHODS
  This prospective observational study, reflective of actual practice patterns, was conducted in men older than 18 years who were prescribed solifenacin for the treatment of OAB symptoms. Men with suspected bladder outlet obstruction were excluded. The primary efficacy measure was change in OAB symptoms after 12 weeks of solifenacin. Also assessed were changes in severity of urinary urgency, IPSS, quality of life, cognitive function, and adverse events. Data were analyzed using descriptive methods.
  
  
  RESULTS
  A total of 799 men recruited at 251 centers, average age 67 years (range 27-92), received solifenacin 5 mg or 10 mg/day. Mean episodes of urinary urgency, frequency, and nocturia decreased by 4.4, 3.6, and 1.4 episodes/24 h, respectively. As per IPSS, severe urinary symptoms were reported by 20.4 % at baseline versus by 2.3 % at week 12. Both voiding and storage symptoms showed improvement. Patient-reported general health condition was excellent/good for 39 % at baseline increasing to 76 % at week 12. Adverse event rate was 5.5 %, and discontinuation of solifenacin due to an event was 1.6 %. No change in post-void residual urine volume was experienced in 80%, while an increase of ≥50 mL was observed in 2.2 %; no cases of acute urinary retention occurred. Baseline mean MMSE was 27.5 points versus 27.9 points at week 12.
  
  
  CONCLUSIONS
  Solifenacin reduced all OAB symptoms, was well tolerated, and had no apparent effect on post-void residual urine volume. Cognitive function was unaltered in this population of older men with OAB.
authors.affiliation: Department of Urology and Pediatric Urology, Julius-Maximilians-University Medical Center, Oberdürrbacher Straße 6, 97080, Würzburg, Germany, maximilianburger@me.com.
authors.forename: Maximilian
authors.initials: M
authors.lastname: Burger
authors.forename: Dietmar
authors.initials: D
authors.lastname: Betz
authors.forename: Christian
authors.initials: C
authors.lastname: Hampel
authors.forename: Monika
authors.initials: M
authors.lastname: Vogel
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003071:Cognition / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D011788:Quality of Life / Q000523:psychology; D011812:Quinuclidines / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use*; D012720:Severity of Illness Index; D000069464:Solifenacin Succinate; D044005:Tetrahydroisoquinolines / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy* / Q000523:psychology; D064804:Urological Agents / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D011812:Quinuclidines; D044005:Tetrahydroisoquinolines; D064804:Urological Agents; D000069464:Solifenacin Succinate