TEST-RETEST RELIABILITY AND ACCLIMATION EFFECT OF PATIENT PERCEPTION OF INTENSITY OF URGENCY SCALE (PPIUS) FOR OVERACTIVE BLADDER

Author(s)

Chen WH1, Notte S1, Marshall TS2, Lee M2, Hakimi Z3, Revicki DA11United BioSource Corporation, Bethesda, MD, USA, 2Astellas Pharma Global Development - US, Deerfield, IL, USA, 3Astellas Pharma Global Development - EU, AC Leiderdorp, Netherlands

OBJECTIVES: A three-day micturition diary has been designed to capture information on the number of urinary and incontinence episodes in overactive bladder (OAB) patients. Within the diary is the Patient Perception of Intensity of Urgency Scale (PPIUS), which captures the urgency associated with each episode. The PPIUS is a single item with five levels of urgency severity: “No urgency,” “Mild urgency” “Moderate urgency,” “Severe urgency,” and “Urge incontinence.” The objective of this study was to assess the test-retest reliability and acclimation effect of the PPIUS. METHODS: OAB patients were recruited from five sites in the US for a non-interventional two-visit study. At the Screening Visit, participants were trained on how to complete the three-day diary at home for three consecutive weeks. In the diary, participants recorded the time of each micturition, a corresponding PPIUS rating, and whether the episode was accompanied by incontinence. Participants and clinicians completed overall treatment effect (OTE) questions at the Final Visit asking whether their bladder condition had changed since the Screening Visit. RESULTS: N=39; mean age=59.1 years; 69.2% Caucasian; 82.1% female; mean (SD) years with symptoms=6.7 (6.78); 94.9% reported medication use for treatment. The mean number of micturitions per 24-hours=10.5, mean number of incontinence episodes per 24-hours=1.8; mean level of urgency severity=1.9. There were 34 (87.2%) and 35 (89.7%) stable patients as defined by OTE-Patient and OTE-Clinician, respectively. Using Weeks 2 and 3 data from stable patients, the intra-class correlation (ICC) was 0.95 and the Spearman correlation was 0.89. The difference between the average ratings of any two weeks was non-significant using paired t-test. CONCLUSIONS: The PPIUS demonstrated excellent test-retest reliability as evidenced by ICC=0.95. Acclimation effect was not observed in the PPIUS, as evidenced by non-significant differences in the average ratings across three weeks.

Conference/Value in Health Info

2010-11, ISPOR Europe 2010, Prague, Czech Republic

Value in Health, Vol. 13, No. 7 (November 2010)

Code

PUK33

Disease

Urinary/Kidney Disorders

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