Validation of the lower urinary tract symptom score.

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.

Safety considerations for synthetic sling surgery.

Implantation of a synthetic midurethral sling (SMUS) is the most commonly performed anti-incontinence operation in women worldwide. The effectiveness of the SMUS is comparable to that of the historical gold standards--autologous fascial slings and the Burch colposuspension. Much controversy, however, has evolved regarding the safety of this type of sling. Overall, the quality of the studies with respect to assessing risks of SMUS-associated complications is currently poor. The most common risks in patients with SMUS include urethral obstruction requiring surgery (2.3% of patients with SMUS), vaginal, bladder and/or urethral erosion requiring surgery (1.8%) and refractory chronic pain (4.1%); these data likely represent the minimum risks. In addition, the failure rate of SMUS implantation surgery is probably at least 5% in patients with stress urinary incontinence (SUI). Furthermore, at least one-third of patients undergoing sling excision surgery develop recurrent SUI. Considering the additional risks of refractory overactive bladder, fistulas and bowel perforations, among others, the overall risk of a negative outcome after SMUS implantation surgery is ≥15%.