A health related quality of life measure for use in patients with urge urinary incontinence: A validation study

Objective: Urge incontinence has substantial impact on health related quali ty of life (HRQOL). The purpose of this research was to test the psychometr ic properties of the Urge-Incontinence Impact Questionnaire (U-IIQ) and Urg e-Urinary Distress Inventory (U-UDI). Methods: The U-IIQ and the U-UDI were incorporated in a single arm study of an investigational once-a-day formul ation of oxybutynin (Ditropan(R) XL) for urge incontinence. The U-IIQ conta ins 7 scales scored separately: Travel, Activities, Physical activities, Fe elings, Relationships, Sexual function and Nighttime bladder control. We al so calculated a single index score. The U-UDI contains 9 items summarized i n a single score that measures the extent to which incontinence symptoms bo ther patients and an urge symptoms summary score. Patients completed the qu estions at: start of baseline week, end of baseline week, week 4 and week 1 2 (final dose). Results: The questions were completed by the 257 patients e nrolled in the study (91% female, mean age = 60 years). All item responses showed good variability. Internal-consistency reliability was very good (Cr onbach's alpha = 0.82-0.96). Test-retest reliability was good for all scale s ([ICC] = 0.68-0.83). Discriminant validity was noted for all scales for p atients with and without frequent incontinence (p less than or equal to 0.0 06 all scales). All scales demonstrated responsiveness to change over time (Guyatt's statistic = - ). Conclusions: Psychometric testing indicated that the scales measured distinct and relevant domains of HRQOL for patients wi th urge incontinence, and that these two instruments are reliable, valid, a nd responsive to change in this condition.