AIM: The purpose of this study was to assess the validity of the Urinary Sensation Scale (USS) in men with overactive bladder and voiding symptoms (OAB-LUTS) and women with overactive bladder (OAB). METHODS: Data from two OAB clinical trials of tolterodine were used. The USS, a 5-point scale, assesses the amount of urinary urgency associated with each urination. Three methods to calculate the USS are: mean urgency (Mean USS); mode urgency (Mode USS); and sum urgency (sum USS). The validity and responsiveness of the scoring methods was assessed using Spearman’s correlations, general linear models, and effect sizes. RESULTS: Data from 650 men (Study 1) and 413 women (Study 2) were analyzed. Mean age was 65.2 (men) and 47.8 (women); 70% were Caucasian in both studies. Correlations of USS scores with bladder diary variables were small to moderate and higher among Sum USS than Mean USS (r = 0.02-0.64). Correlations among the USS and patient-reported outcomes (PROs) were again small to moderate and higher with Sum USS (r = 0.05-0.41). Both the Mean USS and Sum USS significantly discriminated (all P < 0.001) among all bladder diary variables (except nocturia and UUI in men) when grouped as improved/not improved as well as by the PROs. 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. CONCLUSION: The USS is a valid and highly responsive measure of urinary urgency in men with OAB-LUTS and women with OAB. © 2011 Wiley-Liss, Inc.
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