ATLANTA—A new oxybutynin gel (OTG) with propylene glycol to aid transdermal delivery, which dispensed via a pump, is effective for treating urgency and mixed urinary incontinence (UI), according to the findings of a phase 3 study presented at the American Urological Association 2012 annual meeting.
The study, by Evan Goldfischer, MD, of Premier Medical Group in Poughkeepsie, N.Y., and colleagues, included 532 patients in the efficacy analysis and 626 in the safety analyses. Patients had a mean age of 59 years and 87% were female. Patients were randomized to receive OTG 56 or 84 mg/day (171 and 195 patients, respectively) or placebo gel (166 patients) for 12 weeks. The gels were applied to the abdomen, inner and upper thighs or upper arm/shoulder. The primary efficacy variable was change from baseline to study end (week 12) in mean number of urinary incontinence episodes as recorded in a three-day bladder diary.
Mean weekly UI episodes declined by 24.8 and 21.9 in the OTG 56 and 84 mg/day recipients, respectively, compared with 20 in the placebo arm. The declines in the two OTG groups were significantly greater than the decline in the placebo group. In addition, the average daily urinary frequency, which was a secondary outcome measure, declined by a mean of 2.2 and 2.9 in the OTG 56 and 84 mg/day groups, respectively, compared with a mean decline of 1.9 in the placebo arm. Urinary void volume increased by a mean of 21.1 and 29 mL in the OTG 56 and 84 mg/day groups, respectively, and by 10.4 mL in the placebo arm.
The most commonly reported treatment-related adverse effect (AE) was dry month; it occurred in 11% and 12.1% of the OTG 56 and 84 mg/day groups, respectively, compared with 5% of the placebo recipients. No serious treatment-related AEs occurred.