OBJECTIVES To assess the efficacy of solifenacin on patient-reported outcomes and diary-documented Overactive Bladder (OAB) symptoms. METHODS 768 patients with OAB for ≥3 months were randomized to flexibly dosed solifenacin (5-10 mg) or placebo for 12 weeks; dose modifications were permitted at Weeks 4 and 8. At baseline and Week 12, patients completed the Overactive Bladder Questionnaire (OAB-q), comprised of a Symptom Bother scale (primary endpoint) and Health-Related Quality of Life (HRQL) scale with 4 domains (Coping, Concern, Sleep, Social Interactions), Work Productivity and Activity Impairment (WPAI) Questionnaire, which assesses the impact of bladder-related problems on absenteeism (work time missed), presenteeism (impairment at work), work productivity loss, and activity impairment, a 100-mm Treatment Satisfaction Visual Analog Scale (TS-VAS; higher values indicate greater satisfaction) and 3-day bladder diaries for recording episodes of urgency, incontinence, micturition frequency, and nocturia. RESULTS By study end, solifenacin versus placebo significantly improved mean OAB-q Symptom Bother (-29.9 vs -20.4, P<0.0001), HRQL total (25.3 vs 16.7, P<0.0001) and all domain scores (all Ps<0.0001). WPAI results revealed that solifenacin versus placebo significantly improved presenteeism (-14.6% vs -8.7%), work productivity loss (-12.9% vs -8.2%), and activity impairment (-18.1% vs -14.7%; all Ps<0.01), but not absenteeism (-0.5 vs 0.1; P=0.50), likely because baseline levels were low (1.1% vs. 1.4%). On the TS-VAS, mean change from baseline was significantly larger among solifenacin versus placebo patients (38.2 vs 18.4; P<0.0001). Solifenacin vs placebo also significantly reduced mean daily episodes of urgency (-3.05 vs -1.84; P<0.0001), incontinence (-1.85 vs -1.24; P=0.003), and frequency (-2.23 vs -1.36; P<0.0001), but not nocturia (-0.63 vs -0.48; P=0.34). CONCLUSIONS Flexibly dosed solifenacin significantly improved OAB symptom bother, HRQL, work productivity, and OAB symptoms. Patients who received solifenacin versus placebo also showed a significantly greater increase in overall treatment satisfaction.