title: Patient-selected goals in overactive bladder: a placebo controlled randomized double-blind trial of transdermal oxybutynin for the treatment of urgency and urge incontinence.
abstract: OBJECTIVE
  To assess patient selected goal improvement with transdermal oxybutynin, in a representative population of adult women with overactive bladder (OAB).
  
  
  METHODS
  Adult women with ≥ 3 month history of OAB symptoms, with or without urgency urinary incontinence, were recruited from a tertiary referral urogynaecology unit. Participants were allocated to either transdermal oxybutynin 3.9 mg/day or matching placebo patches in a double-blind, randomized parallel group design, over 4 weeks. Patient-selected goal achievement was defined as the primary outcome measure. Participants selected their own goals for treatment at baseline, and subsequently scored achievement of these goals on a visual analogue scale. They completed 3-day bladder diaries incorporating the Patients Perception of Intensity of Urgency Scale (PPIUS) to assess urgency and urgency incontinence episodes. Quality of life was assessed using the King's Health Questionnaire (KHQ).
  
  
  RESULTS
  A total of 96 women were randomized; 78 (81.3%) participants completed 4 weeks double-blind treatment. There was no significant difference between mean goal achievement in the transdermal oxybutynin and placebo groups (41.9% (SD 31.3) vs 32.2% (SD 27.3), P= 0.203). Transdermal oxybutynin was associated with significant improvements in urgency episodes (-1.23 episodes/day (SD1.40) vs -0.21 episodes/day (SD 1.58), P= 0.01). Both groups made non-significantly different improvements in KHQ scores; 18 (38.2%) patients in the transdermal oxybutynin group experienced either erythema or pruritus, with 7 (14.9%) experiencing at least one systemic adverse event.
  
  
  CONCLUSIONS
  In women with OAB, in comparison with placebo, transdermal oxybutynin 3.9 mg/day leads to significant objective improvements in urinary urgency, but with no significant difference observed in achievement of patients' own goals for therapy, or improvement in disease specific quality of life.
authors.affiliation: Department of Urogynaecology, King's College Hospital, London, UK. rufus.cartwright@gmail.com
authors.forename: Rufus
authors.initials: R
authors.lastname: Cartwright
authors.forename: Sushma
authors.initials: S
authors.lastname: Srikrishna
authors.forename: Linda
authors.initials: L
authors.lastname: Cardozo
authors.forename: Dudley
authors.initials: D
authors.lastname: Robinson
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004812:Epidemiologic Methods; D005260:Female; D006040:Goals; D006801:Humans; D008333:Mandelic Acids / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D010358:Patient Participation; D011788:Quality of Life; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000150:complications / Q000188:drug therapy*; D053202:Urinary Incontinence, Urge / Q000188:drug therapy* / Q000209:etiology
chemical_list: D008333:Mandelic Acids; D018727:Muscarinic Antagonists; C005419:oxybutynin