THE PATIENT PERCEPTION OF INTENSITY OF URGENCY SCALE (PPIUS)- ITS VALIDATION IN MEN WITH LOWER URINARY TRACT SYMPTOMS (LUTS) ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA (BPH)

Author(s)

Mathias SD*1;Crosby R1;Klaver M2;Drogendijk T2;Hakimi Z2, Odeyemi IA3 1Health Outcomes Solutions, Winter Park, FL, USA, 2Astellas Pharma Global Development, Leiden, Netherlands, 3Astellas Pharma Europe Ltd, Chertsey, United Kingdom

OBJECTIVES: The PPIUS is a single-item patient-reported rating scale capturing degree of urgency associated with micturition and/or incontinence. We evaluated its measurement properties in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). METHODS: Subjects enrolled in a Phase II, randomized, double-blind, 12-week study of fixed dose combinations of solifenacin with tamsulosin in an Oral Control Administration System (OCASTM) formulation TOCAS monotherapy, and placebo completed several disease specific patient reported outcomes and rated their level of urgency at every micturition and number of incontinence episode using the PPIUS prior to visits 2 (baseline), 3, 4, and 6 (end of study [EOS]). Six different scores were derived from the PPIUS including the mean, maximum, Total Urgency and Frequency Score (TUFS)* (defined as average sum of urgency episodes during a 24 hour period), number of urgency episodes, number of severe urgency episodes, and number of urge incontinence episodes. Measurement properties, including reliability, validity and responsiveness, were assessed. RESULTS: 1,010 males (mean age: 66) were enrolled. Intra class correlations (test-retest reliability) exceeded 0.70 for all scores. All PPIUS scores at Visit 2 and EOS were significantly (p<0.001) different for those above/below the median on International Prostate Symptom Score (IPSS) storage scores, but TUFS and number of urgency episodes had highest partial eta-squared values indicating these scores demonstrated the greatest ability to discriminate between groups differing in baseline severity (known groups validity). Three PPIUS scores (maximum, TUFS and urgency episodes) showed notably higher values across all four responsiveness measures.  Findings were similar in the subgroup of patients with high storage symptoms at baseline. CONCLUSIONS: This large study provided a comprehensive examination of the measurement properties of the PPIUS. The TUFS provided an excellent combination of measurement properties and is therefore considered one of the most appropriate PPIUS endpoint for use in studies of patients with LUTS associated with BPH.

Conference/Value in Health Info

2013-05, ISPOR 2013, New Orleans, LA, USA

Value in Health, Vol. 16, No. 3 (May 2013)

Code

PRM136

Topic

Economic Evaluation, Methodological & Statistical Research

Topic Subcategory

Cost-comparison, Effectiveness, Utility, Benefit Analysis, PRO & Related Methods

Disease

Urinary/Kidney Disorders

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