Get access

Efficacy and safety of oxybutynin topical gel 3% in patients with urgency and/or mixed urinary incontinence: A randomized, double-blind, placebo-controlled study

Authors


  • [Correction added on 24 March 2014, after first online publication: the second sentence of the Results section in the abstract has been amended to indicate the cutoff for significance in the P values for weekly urinary incontinence episodes and for daily urinary frequency.]
  • Eric Rovner led the peer-review process as the Associate Editor responsible for the paper.
  • Conflict of interest: Evan R. Goldfischer has been a consultant for Janssen, Dendreon, Ferring, Watson; has received speaker honorarium from Janssen, Dendreon, Ferring, Watson, and Lilly; has received fellowship, travel grants from Watson; and has participated in trials with Janssen, Ferring, Watson, Euclid Diagnostics, Endo, Vitros, Active Biotech, Ortho Clinical Diagnostics, Healthever, Johnson & Johnson, Pfizer, Serenity, Biosante, Astellas, GP Pharm, Boehringer Ingelheim, Medispec, Protox, Pom Wonderful, Afferent, Amneal, Vantia, Allergan, Medivation/Strive, and Bnit. Peter K. Sand has been a consultant for Allergan, Astellas, Merck, Ferring, Pfizer and Watson; has received speaker honorarium from Allergan, Astellas, Pfizer, and Watson; has participated in trials with Allergan, Astellas, Ferring, Contura, Bioform, Boston Scientifc, and Watson; and has received research grants from Boston Scientific. Heather Thomas has equity interests in and is an employee of Watson Laboratories. Jill Peters-Gee has equity interests in Pfizer; has received speaker honorarium from Pfizer, Allergan, and Warner-Chilcott; and has participated in trials with Pfizer, Allergan, Astellas, Targacept, and Afferent.

Abstract

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 < 0.05a), daily urinary frequency (−2.6 vs. −1.9; P = 0.001b), and urinary void volume (32.7 vs. 9.8; P < 0.0001b). 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.

Ancillary