MP84-07 PERFORMANCE AND CORRELATION OF EFFICACY ENDPOINTS IN A CLINICAL TRIAL OF PREMATURE EJACULATION

Abstract

You have accessJournal of UrologySexual Function/Dysfunction: Evaluation II1 Apr 2017MP84-07 PERFORMANCE AND CORRELATION OF EFFICACY ENDPOINTS IN A CLINICAL TRIAL OF PREMATURE EJACULATION Ray Rosen, Stanley Althof, Ian Osterloh, Gary Muirhead, Christopher McMahon, Brian Harty, and Francois Giuliano Ray RosenRay Rosen More articles by this author , Stanley AlthofStanley Althof More articles by this author , Ian OsterlohIan Osterloh More articles by this author , Gary MuirheadGary Muirhead More articles by this author , Christopher McMahonChristopher McMahon More articles by this author , Brian HartyBrian Harty More articles by this author , and Francois GiulianoFrancois Giuliano More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.2648AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Efficacy Assessments in trials of Premature Ejaculation (PE) include intravaginal ejaculatory latency time (IELT), Clinical Global Impression of Change (CGIC) and the Premature Ejaculation Profile (PEP). The objective of this paper is to systematically compare and correlate the IELT, CGIC and PEP data from a clinical trial recruiting men with lifelong PE. METHODS Patients in Trial NCT02232425 recorded IELT measured by stopwatch and 2 PEP questions (ejaculation control and ejaculation-related distress) using an e-diary daily during 4 weeks prior to treatment and 8 weeks of study drug treatment. Patients also completed all 4 PEP questions every 4 weeks, and the CGIC at end of treatment. PEP questions on control and distress were scored 0 (worst) to 4 (best response). Treatment groups were analyzed together. IELT, CGIC and PEP results were systematically compared. Descriptive statistics, correlation coefficients (Pearson and Spearman) and Bland-Altman plots were produced for each treatment interval. Box and whisker plots were produced by category of improvement in PEP question scales. RESULTS Data collected daily via e-Diary and based on 4-week recall showed equivalent results (Figure 1 shows results for distress). Each endpoint was sensitive to treatment-related change, and all measures showed a high degree of concordance with one another. For example, improvements in IELT correlated with improved control and reduction in ejaculation-related distress (Figure 2). Men with lifelong PE generally perceived improvement in their condition when their IELT increased by approximately 40 seconds or more, or the fold increase in IELT was 2.5 or greater. CONCLUSIONS The results strongly support the use of these efficacy instruments in PE studies. The combination of objective (IELT) and subjective (PEP, CGIC) measures is necessary and appropriate for assessing treatment benefit in men with PE. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e1141-e1142 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Ray Rosen More articles by this author Stanley Althof More articles by this author Ian Osterloh More articles by this author Gary Muirhead More articles by this author Christopher McMahon More articles by this author Brian Harty More articles by this author Francois Giuliano More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...