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Erectile Dysfunction Assessment

Erectile Dysfunction - June 16, 2008 - Comments (0)

The advent of effective oral therapies for erectile dysfunction (ED) has led to significant changes not only in the clinical management of this disorder, but also in the design and conduct of clinical trials. Whereas laboratory-based studies had previously relied on objective or physiological recording techniques, such as penile plethysmography or doppler ultrasonography, these methods are not suitable for use in evaluating efficacy of an oral erectogenic agent, such as sildenafil. Given the mechanism of action of PDE-5 inhibitors, particularly the need for adequate sexual stimulation, it is apparent that less obtrusive, patient-based methods of assessment are required.

Early in the development of sildenafil, Pfizer recognized the need for better efficacy instruments for erectile and sexual dysfunction. After developing an initial version of the questionnaire that was successfully used in early Phase II trials, the company elicited the help of an international panel of experts to further refine and validate the questionnaire. Accordingly, the International Index of Erectile Function (IIEF) was developed and validated in 1996-1997 as an adjunct to the sildenafil clinical trial program.

The International Index of Erectile Function (IIEF) is a widely used, multi-dimensional self-report instrument for the evaluation of male sexual function. It is has been recommended as a primary endpoint for clinical trials of erectile dysfunction (ED) and for diagnostic evaluation of ED severity. The IIEF was developed in conjunction with the clinical trial program for sildenafil, and has since been adopted as the ‘gold standard’ measure for efficacy assessment in clinical trials of ED. It has been linguistically validated in 32 languages and used as a primary endpoint in more than 50 clinical trials.

It has demonstrated consistent and robust treatment responsiveness in studies in USA, Europe and Asia.

Rosen et al developed a shortened version of the 15-item International Index of Erectile Function (IIEF) that contained 5 items the IIEF-5. The items focus on erectile function and intercourse satisfaction. This was shown to be an excellent diagnostic test for erectile dysfunction.

The 5-Item Version of the International Index of Erectile Function (IIEF-5)

Calculate your ED score here and go here to get your score interpretation.

Interpretation:

• minimum score: 1

• maximum score: 25

• The higher the score the better the erectile function.

Score	Interpretation
22 – 25	no erectile dysfunction
17 – 21	mild erectile dysfunction
12- 16	mild to moderate erectile dysfunction
8 – 11	moderate erectile dysfunction
5 - 7	severe erectile dysfunction