title: Validation of the Patient Perception of Intensity of Urgency Scale in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia.
abstract: OBJECTIVE
  To assess the reliability and validity of scores derived from the Patient Perception of Intensity of Urgency Scale (PPIUS) in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
  
  
  METHODS
  A post hoc analysis of the phase II Solifenacin and Tamsulosin in Males with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia trial (NCT00510406), a 12-week clinical trial in men with LUTS associated with BPH, assessed the measurement properties of six PPIUS-derived scores: mean score; maximum urgency score; total urgency and frequency score (TUFS; average sum of urgency scores over 3 days); and numbers of urgency episodes, urgency episodes of grade 3 or 4, and urgency incontinence episodes. Test-retest reliability, presence of floor/ceiling effects, responsiveness to change, known-group validity, and concurrent validity were assessed for each score.
  
  
  RESULTS
  A total of 901 patients had at least one valid PPIUS assessment after baseline. TUFS demonstrated good test-retest reliability (intraclass correlation coefficient >0.8), discriminated between groups defined based on International Prostate Symptom Score storage score severity (known-groups validity), had high concurrent validity, and had high responsiveness to change (Guyatt's responsiveness statistic 0.88), with an absence of floor or ceiling effects. The psychometric properties of other PPIUS-derived scores were not as consistently robust and showed either low-to-moderate responsiveness, presence of a floor or ceiling effect, or low-to-moderate test-retest reliability.
  
  
  CONCLUSIONS
  This study shows that the PPIUS is reliable and valid in patients with LUTS associated with BPH. TUFS provided the best combination of psychometric properties of the six scores derived from the PPIUS and appeared to be an appropriate measure of urgency and frequency.
authors.affiliation: Health Outcomes Solutions, Winter Park, FL, USA. Electronic address: smathias@healthoutcomessolutions.com.
authors.forename: Susan D
authors.initials: SD
authors.lastname: Mathias
authors.affiliation: Health Outcomes Solutions, Winter Park, FL, USA; Neuropsychiatric Research Institute, Fargo, ND, USA; University of North Dakota School of Medicine and Health Sciences, Grand Forks, ND, USA.
authors.forename: Ross D
authors.initials: RD
authors.lastname: Crosby
authors.affiliation: Astellas Pharma Europe Ltd., Chertsey, UK.
authors.forename: Jameel
authors.initials: J
authors.lastname: Nazir
authors.affiliation: Astellas Pharma Global Development, Leiden, The Netherlands.
authors.forename: Monique
authors.initials: M
authors.lastname: Klaver
authors.affiliation: Astellas Pharma Global Development, Leiden, The Netherlands.
authors.forename: Ted
authors.initials: T
authors.lastname: Drogendijk
authors.affiliation: Astellas Pharma Global Development, Leiden, The Netherlands.
authors.forename: Zalmai
authors.initials: Z
authors.lastname: Hakimi
authors.affiliation: Astellas Pharma Europe Ltd., Chertsey, UK.
authors.forename: Isaac A
authors.initials: IA
authors.lastname: Odeyemi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000150:complications / Q000188:drug therapy / Q000523:psychology*; D008297:Male; D008875:Middle Aged; D011470:Prostatic Hyperplasia / Q000150:complications / Q000188:drug therapy / Q000523:psychology*; D011594:Psychometrics; D011812:Quinuclidines / Q000627:therapeutic use; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D000069464:Solifenacin Succinate; D013449:Sulfonamides / Q000627:therapeutic use; D011795:Surveys and Questionnaires; D000077409:Tamsulosin; D044005:Tetrahydroisoquinolines / Q000627:therapeutic use; D064804:Urological Agents / Q000627:therapeutic use
chemical_list: D011812:Quinuclidines; D013449:Sulfonamides; D044005:Tetrahydroisoquinolines; D064804:Urological Agents; D000077409:Tamsulosin; D000069464:Solifenacin Succinate
keywords: Patient Perception of Intensity of Urgency Scale; benign prostatic hyperplasia; lower urinary tract symptoms; validation