title: Comparative efficacy and safety of transdermal oxybutynin and oral tolterodine versus placebo in previously treated patients with urge and mixed urinary incontinence.
abstract: OBJECTIVE
  To compare the efficacy and safety of an oxybutynin transdermal delivery system (OXY-TDS) and oral, long-acting tolterodine (TOL-LA) with placebo in previously treated patients with urge or mixed urinary incontinence.
  
  
  METHODS
  After withdrawal of their current antimuscarinic therapy, 361 adult patients were randomized to 12 weeks of double-blind, double-dummy treatment with twice weekly OXY-TDS 3.9 mg/day, daily TOL-LA 4 mg, or placebo. Evaluations included change from baseline in patient urinary diary symptoms, incontinence-specific quality of life, and safety.
  
  
  RESULTS
  OXY-TDS 3.9 mg/day and TOL-LA 4 mg/day significantly reduced the number of daily incontinence episodes (median change -3 OXY-TDS and -3 TOL-LA versus -2 placebo; P <0.05), increased the average void volume (median change 24 and 29 mL versus 5.5 mL, P <0.01), and improved quality of life (incontinence impact questionnaire [IIQ] total score, P <0.05; Urogenital Distress Inventory Irritative Symptom subscale, P <0.05) compared with placebo. The most common adverse event for OXY-TDS was localized application site pruritus (14% versus 4% placebo) accompanied by a low incidence of systemic side effects (eg, dry mouth 4.1%). Anticholinergic adverse events occurred with greatest frequency during TOL-LA treatment (dry mouth 7.3% versus 1.7% placebo, P <0.05).
  
  
  CONCLUSIONS
  OXY-TDS and TOL-LA are effective and comparable treatments for patients with urge and mixed incontinence. OXY-TDS improves systemic safety with regard to anticholinergic side effects. Local skin irritation occurs in some OXY-TDS patients.
authors.affiliation: Department of Urology, Vanderbilt University, Nashville, Tennessee, USA.
authors.forename: Roger R
authors.initials: RR
authors.lastname: Dmochowski
authors.forename: Peter K
authors.initials: PK
authors.lastname: Sand
authors.forename: Norman R
authors.initials: NR
authors.lastname: Zinner
authors.forename: Marc C
authors.initials: MC
authors.lastname: Gittelman
authors.forename: G Willy
authors.initials: GW
authors.lastname: Davila
authors.forename: Steven W
authors.initials: SW
authors.lastname: Sanders
mesh_terms: D000279:Administration, Cutaneous; D000284:Administration, Oral; D001559:Benzhydryl Compounds / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D003408:Cresols / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D003877:Dermatitis, Contact / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008333:Mandelic Acids / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000188:drug therapy*
chemical_list: D001559:Benzhydryl Compounds; D003408:Cresols; D008333:Mandelic Acids; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate; C005419:oxybutynin