OBJECTIVES: Overactive bladder (OAB) is characterized by bothersome symptoms of urinary frequency and urgency that occur with or without urge incontinence, and it has been shown to have significant impact on health-related quality of life (HRQL). Since OAB is defined by symptoms, the evaluation of treatment effectiveness should be based upon patient perception. The purpose of this study was to assess the validity and responsiveness of a global patient-report measure - the Perception of Bladder Condition (PBC) in Overactive Bladder. METHODS: OAB patients were treated with Tolterodine Extended Release 4 mg/day for 12 weeks. Patient evaluations, which included the PBC, OAB-q (measure of symptom bother and HRQL), and micturition variables (3-day diaries: frequency, incontinence, urgency), were conducted at baseline, 4 weeks, and 12 weeks. The PBC is a single item that assesses current urinary problems on a 6-point scale. PBC scores were evaluated with other measures of treatment efficacy using t-tests and ANOVAs for all assessment periods. RESULTS: 865 patients completed the study (mean age=61 years; 73% female; 89% Caucasian). Higher severity PBC responses were significantly associated with greater symptom bother and lower HRQL at each assessment period (p<0.05). Associations between PBC and micturition variables followed similar patterns. Compared with patients who did not report improvement on the PBC, patients who improved demonstrated significantly greater improvement from baseline to week 12 on all OAB-q scales (p<0.0001), micturition frequency (p<0.0001), incontinence episodes (p<0.002), and urgency episodes (p<0.005). Patients reporting major improvement on the PBC (>2 response options) consistently demonstrated significantly greater improvement on other efficacy measures compared to patients reporting minor improvement. CONCLUSIONS: The Perception of Bladder Condition demonstrated good construct validity and responsiveness among patients receiving Tolterodine Extended Release 4 mg/day for Overactive Bladder. It appears to be a useful tool for evaluating patients' global impressions of bladder condition in clinical trials of OAB treatments.