OBJECTIVES: To assess the validity of the Urinary Sensation Scale (USS) in women with overactive bladder (OAB) and men with OAB and prostate symptoms (OAB-BPH). METHODS: Data from 2 clinical trials of tolterodine treatment for OAB were used to assess the validity of the USS, a 5-point rating scale to assess the amount of urinary urgency associated with each urination.  The USS ranges from “No feeling of urgency: I could continue activities until I chose to use the bathroom” to “Unable to hold; leak urine: I had a wetting accident before arriving at the bathroom.”  The USS was administered with a daily bladder diary in the 2 trials. Two methods to evaluate the USS are to calculate a mean urgency score (Mean USS) of all voids or to sum all urgency ratings (Sum USS). Concurrent validity, discriminant validity, and responsiveness of the USS were assessed. RESULTS: Data from 580 men (Trial 1) and 331 women (Trial 2) were analyzed.  Mean age was 65.2 (men) and 47.8 (women); in both studies, 70% were Caucasian. Correlations of USS scores with bladder diary variables were small to moderate and higher among Sum USS than Mean USS.  Correlations among the USS with OAB-q, Perception of Bladder Condition (PBC), and Perception of Treatment Benefit (PTB) were moderate to strong and higher with Sum USS.  Both the Mean and Sum USS significantly discriminated (all p <0.001) among all bladder diary variables (except men, nocturia and UUI) when grouped as improved/not improved as well as by the OAB-q, PBC, and PTB.  Effect sizes for men and women respectively were -0.52 and -1.09 for Mean USS and -0.72 and -1.36 for Sum USS. CONCLUSIONS: The USS is a valid and highly responsive measure of urinary urgency in women with OAB and men with OAB-BPH.