Methodology of Diagnostic Research

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In PE studies, the study population should be well-characterized, representative of the overall patient population, and defined using a multivariate definition of PE. As the etiology, pathogenesis and treatment of lifelong and acquired PE is different, one should make a clear distinction in both types of PE. Accordingly this should be represented by a clear difference in inclusion and exclusion criteria. Men with lifelong and acquired PE should be treated as demo-

graphically and etiologically distinct disorders and analyzed as separate PE subgroups [42].

Subjects should be involved in a stable, monogamous heterosexual relationship, prepared to attempt intercourse on a regular basis, and provide written informed consent. The presence of comorbid erectile dysfunction (ED) should be evaluated using a validated instrument such as the international index of erectile function (IIEF), and patients with any degree of ED should be either excluded from the study or treated as a separate subgroup. Patients with hypoactive sexual desire or other sexual disorders, urogenital infection, major psychiatric disorders, a history of drug and alcohol abuse or contraindications to the study drug should be excluded from the study.

A very important issue is the definition of lifelong PE and acquired PE. In recent years most attention has focused on an adequate definition of lifelong PE and much less to acquired PE. For the diagnosis of lifelong PE both objective and subjective items have been proposed but none are universally accepted. As such, a consensus of a definition of lifelong PE has not been reached. There is general agreement that the DSM definition of PE is vague and multi-interpretable [12]. It contains mainly qualitative descriptions and not quantitative values, which makes the current DSM-IV definition inappropriate for scientific research. Research papers stating that PE is defined by the DSM-IV definition should therefore add more diagnostic information of the patients that are included in the study. Outcome measures such as the intravaginal ejaculation latency time (IELT), and patient subjective assessments of control, distress (bother), and sexual satisfaction, using validated patient reported instruments [26-28], form the basis of diagnostic research.

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