title: Efficacy and safety of oxybutynin topical gel 3% in patients with urgency and/or mixed urinary incontinence: a randomized, double-blind, placebo-controlled study.
abstract: OBJECTIVE
  To assess the efficacy and safety of oxybutynin transdermal gel 3% (OTG3%), with propylene glycol for enhanced skin permeation, in patients with urinary incontinence (UI).
  
  
  METHODS
  In this phase 3 study, 626 patients ≥18 years old with urgency and/or mixed UI symptoms and predominantly urgency UI for ≥3 months were randomized 1:1:1 to receive 12 weeks of OTG3% 84 mg, OTG3% 56 mg, or placebo gel applied once daily to abdomen, inner/upper thigh, or upper arm/shoulder. Primary efficacy endpoint was change from baseline to Week 12 in weekly UI episodes recorded in 3-day bladder diaries. Results were compared using analysis of covariance. Adverse events (AEs) were monitored.
  
  
  RESULTS
  Efficacy was assessed in 601 (intent-to-treat) and safety in 626 patients. At 12 weeks, OTG3% 84 mg/day achieved significantly greater improvement versus placebo in weekly UI episodes (mean change from baseline: -20.4 vs. -18.1; P < 0.05(a)), daily urinary frequency (-2.6 vs. -1.9; P = 0.001(b)), and urinary void volume (32.7 vs. 9.8; P < 0.0001(b)). Dry mouth, the most common treatment-related AE, occurred more often with OTG3% 84 mg/day (26/214 [12.1%]) vs. placebo (10/202 [5.0%]) (P = 0.028); 4 OTG3% patients withdrew because of dry mouth. Application site erythema occurred more often with OTG3% 84 mg/day (8/214 [3.7%]) versus placebo (2/202 [1.0%]) (P = NS); 12 OTG patients withdrew because of skin irritation. No serious treatment-related AEs occurred.
  
  
  CONCLUSIONS
  OTG3% 84 mg/day was well tolerated and effective in improving urge incontinence or mixed UI symptoms with a predominance of UI in adults with overactive bladder.
authors.affiliation: Premier Medical Group of the Hudson Valley, Poughkeepsie, NY.
authors.forename: Evan R
authors.initials: ER
authors.lastname: Goldfischer
authors.forename: Peter K
authors.initials: PK
authors.lastname: Sand
authors.forename: Heather
authors.initials: H
authors.lastname: Thomas
authors.forename: Jill
authors.initials: J
authors.lastname: Peters-Gee
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D008333:Mandelic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D011788:Quality of Life; D016896:Treatment Outcome; D014549:Urinary Incontinence / Q000188:drug therapy*; D064804:Urological Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D005782:Gels; D008333:Mandelic Acids; D064804:Urological Agents; C005419:oxybutynin
keywords: administration; overactive bladder; oxybutynin; topical; urinary incontinence, stress; urinary incontinence, urge