Psychometric Evaluation of Brief Patient-reported Outcome Measures of Overactive Bladder: The ICIQ-SF, SAC, SATS, SATT, and TBS

Abstract

Objective Overactive bladder (OAB), a bothersome condition that affects many, is best measured using patient-reported outcomes (PROs). This study was conducted to examine the psychometric properties of 5 brief OAB measures: International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), Subject's Assessment of Condition (SAC), Subject's Assessment of Treatment Satisfaction (SATS), Subject's Assessment of Treatment Tolerance (SATT), and Treatment Benefit Scale (TBS). Study Design These secondary analyses of 2 12-week studies of fesoterodine in OAB patients utilized PRO data from Baseline and Week 12. The concurrent and discriminant validity and responsiveness of each measure were evaluated using Spearman's correlations and general linear models. Results There were 798 US patients (Study 1) and 1097 international patients (Study 2) analyzed. Mean age was 58.9 and 56.7 years, with the majority women (75.9% and 80.6%), respectively, in Study 1 and Study 2. The ICIQ-SF and SAC were moderately correlated with most King's Health Questionnaire (KHQ) subscales; the SATT and SATS had weak correlations with the KHQ. Urinary urgency incontinence episodes were highly correlated with the ICIQ-SF, but weak correlations were present with all other PROs and bladder diary variables. The ICIQ-SF significantly discriminated between wet and dry OAB patients. The SAC, SATS, and TBS significantly discriminated between patients who had improved versus not improved in micturition frequency and urinary urgency incontinence episodes. The SATT significantly discriminated among patients reporting adverse events versus no adverse events. Conclusions The ICIQ-SF, SAC, TBS, SATT, and SATS are brief, useful measures that can be used in research settings and by health care providers in clinical settings who wish to quickly evaluate patients' treatment.