Validation of the urinary sensation scale (USS).
OBJECTIVE
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.


CONCLUSIONS
The USS is a valid and highly responsive measure of urinary urgency in men with OAB-LUTS and women with OAB.
United BioSource Corporation, Center for Health Outcomes Research, Bethesda, Maryland 20814, USA. karin.coyne@unitedbiosource.com
Karin S
KS
Coyne
Mary Kay
MK
Margolis
Ray
R
Hsieh
Vasudha
V
Vats
Christopher R
CR
Chapple
D000368:Aged; D001559:Benzhydryl Compounds / Q000627:therapeutic use; D003408:Cresols / Q000627:therapeutic use; D005260:Female; D006801:Humans; D016014:Linear Models; D008297:Male; D015337:Multicenter Studies as Topic; D018727:Muscarinic Antagonists / Q000627:therapeutic use; D010465:Perception; D010665:Phenylpropanolamine / Q000627:therapeutic use; D011237:Predictive Value of Tests; D016032:Randomized Controlled Trials as Topic; D015203:Reproducibility of Results; D012677:Sensation / Q000187:drug effects; D011795:Surveys and Questionnaires; D000068737:Tolterodine Tartrate; D001743:Urinary Bladder / Q000187:drug effects / Q000294:innervation*; D053201:Urinary Bladder, Overactive / Q000175:diagnosis* / Q000188:drug therapy / Q000503:physiopathology / Q000523:psychology; D014563:Urodynamics
D001559:Benzhydryl Compounds; D003408:Cresols; D018727:Muscarinic Antagonists; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate