Introduction: To develop and validate a lower urinary tract symptom score (LUTSS) as a measure of lower urinary tract symptom (LUTS) severity and a treatment outcome tool in adults.
Materials and methods: An expert panel was convened to develop the LUTSS questionnaire. Content validity was achieved by obtaining subject and expert feedback from two prospective drafts. Subjects were divided into three groups: normal, LUTS and overactive bladder (OAB). Questionnaire was administered on two separate occasions within 1-2 weeks. Test-retest reliability, internal consistency, discriminant validity, criterion validity and responsiveness to change were also assessed.
Results: The questionnaire contains 14 questions with answers scored on a 5-point Likert scale (0-4). It includes 9 storage, 4 voiding and 1 bother question. One hundred ninety-one patients completed it; 80 males and 111 females, mean age 65 years (range 22-91). Seventy-two had OAB, 91 LUTS without OAB and 28 were normal. Test-retest intraclass correlation was 0.96 and Cronbach's-□ was 0.77, indicating strong test-retest reliability and internal consistency, respectively. ANOVA and post-hoc bootstrap-generated adjustments showed significant differences between the three groups (p < 0.001), demonstrating discriminant validity. Responsiveness to change was exhibited by the significant decrease between preop and postop scores and a concurrent patient global impression of improvement (PGI-I) score indicative of symptomatic improvement.
Conclusion: The 14-question LUTSS is a validated questionnaire that assesses a full range of LUTS in men and women. The ordinal nature of the data with its highly specific description of symptoms makes it ideally suited as a nuanced and comprehensive symptom score and patient reported outcome (PRO) tool.