MP45-05 A VALIDATED PATIENT REPORTED OUTCOME FOR PREMATURE EJACULATION

Abstract

You have accessJournal of UrologyCME1 Apr 2023MP45-05 A VALIDATED PATIENT REPORTED OUTCOME FOR PREMATURE EJACULATION Michael Wyllie Michael WyllieMichael Wyllie More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003291.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: A major stumbling block for the approval of drugs for the treatment of premature ejaculation (PE) in the USA has been the lack of a patient reported outcome (PRO) validated to FDA standards. Under FDA guidance a PRO, the premature ejaculation bothersome evaluation questionnaire (PEBEQ) has been developed and run in a 16 centre US validation study. A comparison was to be made with other questionnaires used in clinical research in premature ejaculation. METHODS: Over the last 3 years, following FDA guidance and input, the PEBEQ has undergone the required validation sequence and has been run in a 16-centre clinical study. In addition to the PEBEQ, data were captured using the domains of the index of premature ejaculation (IPE) and a per event anchor i.e. the classical IELT measured via a stopwatch. A time stamper was also used to ensure protocol adherence. The patients were double-blind randomised to either active or placebo. In the validation study the active comparator used was PSD502, the metered dose aerosolized eutectic mixture of lidocaine and prilocaine. RESULTS: Clinically significant IELT changes from baseline (<0.7min) were noted for active, representing an 8-9-fold increase for active but only 2-3-fold for placebo. These changes were associated with corresponding increases in control, sexual satisfaction and decreases in distress in the domains of the IPE. Likewise changes in PEBEQ were observed for the active from both baseline and placebo (p< 0.0008 in the case of the latter). Concordance between the domains of the IPE and PEBEQ were in the range 0.79 to 0.89. Compliance was good with 92% of patients completing the study and side effects were minimal. CONCLUSIONS: FDA has been critical of other PROs in so far as the focus has been on "distress" rather than "bother". Under FDA guidance this has been addressed withe the development of the PEBEQ. The data presented show that patients do not necessarily differentiate between distress and bother, in terms of the presenting symptoms of premature ejaculation. Hopefully, the acceptance of the PEBEQ will expedite approval of drugs for premature ejaculation in the USA. Source of Funding: Funding for the validation exercise was provided to Health Research Associates (Evidera) and a US based CRO by Plethora Solutions Ltd © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e622 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Michael Wyllie More articles by this author Expand All Advertisement PDF downloadLoading ...