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Efficacy and safety of oxybutynin topical gel 3% in patients with urgency and/or mixed urinary incontinence: A randomized, double‐blind, placebo‐controlled study
Author(s) -
Goldfischer Evan R.,
Sand Peter K.,
Thomas Heather,
PetersGee Jill
Publication year - 2015
Publication title -
neurourology and urodynamics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 90
eISSN - 1520-6777
pISSN - 0733-2467
DOI - 10.1002/nau.22504
Subject(s) - medicine , placebo , adverse effect , urinary incontinence , erythema , randomized controlled trial , urinary system , oxybutynin , overactive bladder , anesthesia , surgery , urology , alternative medicine , pathology
Aims 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. Neurourol. Urodynam. 34:37–43, 2015 . © 2013 Wiley Periodicals, Inc.