Purpose: We validated a simple scale to measure urinary urgency.
Materials and methods: The new 10-item scale was validated using data from experiments using a single group repeated measure design. A total of 475 patients, including 411 females and 64 males, with a mean age of 57.3 years who had been diagnosed with overactive bladder were treated with a bladder retraining regimen and antimuscarinic agent (10 mg oxybutynin controlled release per night or 4 mg tolterodine slow release per night). At each visit patient urge symptoms were recorded by the scale. Reported average daily frequency and incontinence episodes were also recorded. Of patients who were not satisfied with the symptoms 130 had 25 mg imipramine per night added to their prescription and in 130 treatment was changed to 10 mg solifenacin per night.
Results: Construct validity was tested by comparing the urgency scale to frequency and to incontinence (Spearman's rank correlation coefficient r = 0.38, p <0.001 and r = 0.15, p <0.001, respectively). Internal consistency showed Cronbach's alpha = 0.83. Test-retest reliability was determined in 30 patients and interobserver reliability was determined in 58 (Pearson's r = 0.99, p <0.001 and r = 0.99, p <0.001, respectively). Internal responsiveness in the imipramine add-on study in 130 patients showed a standardized response mean of 0.6 (p <0.001) and in the solifenacin swap study in 130 it showed a standardized response mean of 0.69, while external responsiveness showed a standardized response mean of 0.69 (each p <0.001).
Conclusions: This scale succeeded in all validation studies. This new scale may prove useful for measuring between-drug differences in efficacy and for monitoring treatment responses in patients with overactive bladder. It now must be tested in a proper double-blind, randomized, controlled trial.