Development and validation of a premature ejaculation diagnostic tool.

OBJECTIVES Diagnosis of premature ejaculation (PE) for clinical trial purposes has typically relied on intravaginal ejaculation latency time (IELT) for entry, but this parameter does not capture the multidimensional nature of PE. Therefore, the aim was to develop a brief, multidimensional, psychometrically validated instrument for diagnosing PE status. METHODS The questionnaire development involved three stages: (1) Five focus groups and six individual interviews were conducted to develop the content; (2) psychometric validation using three different groups of men; and (3) generation of a scoring system. For psychometric validation/scoring system development, data was collected from (1) men with PE based on clinician diagnosis, using DSM-IV-TR, who also had IELTs < or =2 min (n=292); (2) men self-reporting PE (n=309); and (3) men self-reporting no-PE (n=701). Standard psychometric analyses were conducted to produce the final questionnaire. Sensitivity/specificity analysis was used to determine an appropriate scoring system. RESULTS The qualitative research identified 9 items to capture the essence of DSM-IV-TR PE classification. The psychometric validation resulted in a 5-item, unidimensional, measure, which captures the essence of DSM-IV-TR: control, frequency, minimal stimulation, distress, and interpersonal difficulty. Sensitivity/specificity analyses suggested a score of < or =8 indicated no-PE, 9 and 10 probable PE, and > or =11 PE. CONCLUSIONS The development and validation of this new PE diagnostic tool has resulted in a new, user-friendly, and brief self-report questionnaire for use in clinical trials to diagnose PE.