title: Efficacy and safety of oxybutynin chloride topical gel for women with overactive bladder syndrome.
abstract: OBJECTIVE
  This subgroup analysis of a phase-3 study evaluated the efficacy and safety of oxybutynin chloride topical gel (OTG) in women with overactive bladder syndrome (OAB).
  
  
  METHODS
  Women (n = 704) with urgency-predominant urinary incontinence received OTG or placebo for 12 weeks. The primary endpoint was change from baseline to last observation in number of daily incontinence episodes. Treatments were compared with the use of analysis of covariance.
  
  
  RESULTS
  OTG significantly reduced the number (mean ± standard deviation) of daily incontinence episodes (OTG, -3.0 ± 2.8 episodes; placebo, -2.5 ± 3.0 episodes; P < .0001), reduced urinary frequency (P = .0013), increased voided volume (P = .0006), and improved select health-related quality-of-life domains (P ≤ .0161) vs placebo. Dry mouth was the only drug-related adverse event significantly more common with OTG (7.4%) than with placebo (2.8%; P = .0062).
  
  
  CONCLUSIONS
  OTG was well tolerated and provided significant improvement in urinary symptoms and health-related quality of life in women with OAB.
authors.affiliation: Evanston Continence Center, NorthShore University HealthSystem, and University of Chicago Pritzker School of Medicine, Chicago, IL 60637, USA. peterksand@gmail.com
authors.forename: Peter K
authors.initials: PK
authors.lastname: Sand
authors.forename: G Willy
authors.initials: GW
authors.lastname: Davila
authors.forename: Vincent R
authors.initials: VR
authors.lastname: Lucente
authors.forename: Heather
authors.initials: H
authors.lastname: Thomas
authors.forename: Kim E
authors.initials: KE
authors.lastname: Caramelli
authors.forename: Gary
authors.initials: G
authors.lastname: Hoel
mesh_terms: D000279:Administration, Cutaneous; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D006801:Humans; D008333:Mandelic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*
chemical_list: D005782:Gels; D008333:Mandelic Acids; D018727:Muscarinic Antagonists; C005419:oxybutynin