Effect of baseline symptom severity on continence improvement mediated by oxybutynin chloride topical gel

BACKGROUND: In a recent placebo-controlled Phase III study, oxybutynin chloride topical gel (OTG) significantly improved urinary continence in patients with overactive bladder. In this post hoc analysis, the effect of incontinence severity on OTG-mediated improvement in continence was evaluated.

METHODS: Change from baseline in the number of incontinence episodes was evaluated in patients with two to three incontinence episodes/day (moderate incontinence) and those with more than three incontinence episodes/day (severe incontinence).

RESULTS: In patients with moderate (n = 171) and severe (n = 556) incontinence, reduction in incontinence episodes (mean ± standard deviation) was greater (P < 0.01) with OTG (moderate, -1.7 ± 1.4; severe, -3.6 ± 3.0) than with placebo (moderate, -1.2 ± 1.3; severe, -3.1 ± 3.4). Continence achievement rate with OTG was 48.2% (placebo, 24.4%) among patients with moderate incontinence and 17.8% (placebo, 12.1%) among those with severe incontinence.

CONCLUSION: Absolute placebo-adjusted reduction in incontinence episodes with OTG was not affected by baseline incontinence severity. Continence achievement was more likely if symptoms were less severe.

Sand, P. K., Macdiarmid, S. A., Thomas, H., Caramelli, K. E., & Hoel, G. (2011). Effect of baseline symptom severity on continence improvement mediated by oxybutynin chloride topical gel. Open Access Journal of Urology, 3, 131–137. https://doi.org/10.2147/OAJU.S24165