Adult urologyRelationship between patient self-assessment of erectile function and the erectile function domain of the international index of erectile function
Section snippets
Study population
The study population consisted of 247 male outpatients with ED of broad-spectrum etiology. Subjects participated in a double-blind, placebo-controlled, multicenter, flexible-dose (25 to 100 mg) Phase IIIb clinical trial in which they were randomized equally to either sildenafil citrate (Viagra) or a corresponding placebo treatment. The primary findings on efficacy, safety, and patient and partner satisfaction have been presented elsewhere.14, 15, 16 Doses were taken as required (but not more
Results
Table II provides a summary of the baseline characteristics of the patients in the study. No differences existed between treatment groups for any of these characteristics.
Figure 1 (baseline) and Figure 2 (end of treatment) depict, for the self-assessed level of severity, the percentage of patients in a severity grade of the EF domain. The two measures showed greater correspondence in classifying no ED (at end of treatment) and severe ED than in classifying mild or moderate ED.
Table III
Comment
Associations between the measures were noticeably lower at baseline than after treatment and the change from baseline. The restricted range of severity grades at baseline reduced the potential variability of responses and hence the correlation between the measures, and the wider distribution of severity grades after treatment increased the variability of responses and hence the correlation between the two measures.18 For example, the EF domain indicated severe ED in 63.6% of the patients at
Conclusions
The moderate-to-high correlations of the EF domain with patients’ self-assessment of ED severity lends support to the use of the EF domain in clinical and research settings as a diagnostic aid for assigning degrees of ED severity. The severity classifications, which address a vital research need, are intended to enhance the decision making of medical researchers, clinicians, and health-care providers who are likely to perform more detailed clinical evaluations in individual cases. The results
Acknowledgements
To Joyce Healey, Sue Huang, and Steve Smith for helpful support.
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Drs. Cappelleri, Siegel, and Osterloh are employees of Pfizer Inc., and Dr. Rosen is a consultant to Pfizer Inc