Topical gel promising for overactive bladder patients

January 31, 2008

An investigational topical treatment for overactive bladder produced a statistically significant reduction in incontinence episodes and a reduction in frequency, while increasing void volume compared with placebo in a phase III study of oxybutynin topical gel in patients with overactive bladder.

An investigational topical treatment for overactive bladder produced a statistically significant reduction in incontinence episodes and a reduction in frequency, while increasing void volume compared with placebo in a phase III study of oxybutynin topical gel in patients with overactive bladder.

“Offering patients the ease and comfort of a daily gel for the treatment of OAB may provide greater patient acceptability and persistence on treatment,” said study co-author Peter K. Sand, MD, of Northwestern University’s Feinberg School of Medicine, Chicago.

Dr. Sand called oxybutynin gel “an elegant topical formulation that is clear, odorless, and fast drying, and will offer health care providers a unique treatment option for OAB patients.”

The phase III, multicenter, double blind, placebo-controlled study evaluated the efficacy and safety of oxybutynin topical gel in 789 patients with overactive bladder. The primary objective of the study was to demonstrate that daily treatment of a 1-gram dose (approximately 1 mL) over 12 weeks was superior to placebo for the relief of OAB symptoms.

Changes from baseline to endpoint were calculated from a 3-day patient urinary diary and included a reduction in incontinence episodes and urinary frequency and an increase in void volume. The treatment was well tolerated in the study, and no serious adverse events were reported. Dry mouth (6.9%) and application site pruritis (2.1%) were the only treatment-related side effects reported at levels greater than 2%.