OBJECTIVES: The PPIUS, previously validated, is a single-item patient-reported rating scale that captures degree of urgency associated with micturition and/or incontinence. We sought to establish the MID of the PPIUS in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). METHODS: Patients with LUTS associated with BPH enrolled in a Phase III, randomized, double-blind, 12-week study of fixed dose combinations of solifenacin succinate with tamsulosin hydrochloride Oral Controlled Absorption System (OCAS), OCAS monotherapy, and placebo completed the PPIUS prior to visits two (baseline), three, four, and five (end of study [EOS]). Three separate scores were derived from the PPIUS including the Total Urgency Score (TUS), mean number of urgency episodes (PPIUS grade three and four) (MNUE), and urgency-incontinence episodes (MNUIE) per 24 hours (for those with >1 incontinence episode). Two Patient Global Impression (PGI) ratings and a Clinical Global Impression (CGI) rating were completed at baseline and EOS. Anchor- and distribution-based MID estimates for the PPIUS were calculated. RESULTS: 1,184 males were enrolled (99% Caucasian; mean age: 65; mean BMI: 28 kg/m2). Correlation analyses supported using CGI and PGI ratings at EOS as anchors for the TUS and one PGI rating for the MNUE. Correlations were too low to estimate the MID for the MNUIE. A 1-unit change in PGI and CGI ratings predicted a change of 3.95-5.79 for TUS and 1.86 for MNUE. Distribution-based estimates resulted in a minimal detectable change (MDC) of 4.57 for TUS and 1.50 for MNUE. After integrating anchor- and distribution-based estimates, the MID estimates for TUS were 5.5-6.0 and 1.8-2.0 for MNUE. CONCLUSIONS:  MID estimates provide guidance for defining clinically meaningful changes, defining a clinical responder, and examining cumulative distribution functions. Future research should confirm these estimates using patients whose condition worsened, and using more relevant anchors for the MNUIE.