Darifenacin treatment of patients ≥65 years with overactive bladder:: results of a randomized, controlled, 12-week trial

Background: Overactive bladder (OAB) increases in prevalence with advancing age. This study specifically investigated patients ! 65 years, evaluating the efficacy, tolerability, safety and quality of life (QoL) outcomes from darifenacin treatment. Methods: Patients (n = 400, mean age 72 years) with OAB were randomized (2:1) to receive 12 weeks of double-blind treatment with darifenacin (7.5 mg once daily for 2 weeks, then optional titration to 15 mg daily) or placebo (with sham titration). Efficacy, tolerability and safety were assessed from patient diary data, adverse events and discontinuations and QoL outcomes using specific questionnaires. Results: Mean urgency urinary incontinence episodes (UUIEs) decreased significantly from baseline to Week 12 with both darifenacin (-88.6%) and placebo (-77.9%; p > 0.05), with 70% and 58% patients responding with >= 50% reductions, respectively (p = 0.021). This was accompanied by significant differences between groups in reductions in micturition frequency (-25.3% with darifenacin vs. -18.5% placebo; p < 0.01). QoL assessments revealed significant improvements with darifenacin versus placebo at Week 12 in OAB-q, Patient Perception of Bladder Condition, and patient and physician assessments of treatment benefit (all p < 0.001). The most commonly reported adverse events were dry mouth and constipation. Conclusions: This study demonstrated that marked improvements in CAB symptoms can be achieved in patients >= 65 years, with significant treatment differences in responder rates, micturition frequency and QoL. Reduction in UUIEs may not be the optimal endpoint in this population, whereas OoL appears to be a sensitive and relevant patient-oriented measure of treatment effect.