Effects of oxybutynin transdermal system on health-related quality of life and safety in men with overactive bladder and prostate conditions

AIMS: Overactive bladder (OAB) is common in men and may exist concomitantly with benign prostatic hyperplasia (BPH) and obstruction. We present a subanalysis of results from men with OAB in a 6-month, open-label study of treatment with the oxybutynin transdermal system (OXY-TDS). Broad entry criteria were incorporated to yield a clinically representative population. METHODS: All participants received OXY-TDS 3.9 mg/day. Effectiveness was assessed by changes in scores on validated questionnaires, which included the single-item Patient Perception of Bladder Condition (PPBC), the King's Health Questionnaire (KHQ) and the Beck Depression Inventory-II (BDI-II). RESULTS: The proportion of men (n = 369; mean age = 69.6 years) who reported that their bladder condition caused moderate, severe or many severe problems (PPBC ≥ 4) improved from 77.3% at baseline to 38.1–53.6% in subsequent months. Mean KHQ scores decreased significantly (p ≤ 0.0196) from baseline to study end in eight of 10 domains, indicating improved health-related quality of life. The proportion of men with BDI-II score > 12 (associated with a diagnosis of depression) decreased from 23.9% to 17.9% (p = 0.0055). Men with a history of ‘prostate problems’ or use of ‘BPH medication’ (32.2%) had KHQ domain changes that were similar (p ≥ 0.1016) to those of other men. Most men (76.2%) reported no treatment-related adverse events; two men (0.5%) experienced symptoms of mild urinary retention, but neither required catheterisation. CONCLUSIONS: Oxybutynin transdermal system treatment of men with OAB was effective and well tolerated, regardless of history of prostate condition.