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This Month's Question:

Response by Tom F. Lue, MD, and David M. Latini, PhD, Posted 03/22/07:

ED has a profound effect on a man’s sense of self and quality of life and creates anxiety that can adversely affect his relationships.¹ Results of the ExCEED study add to the growing body of evidence that ED has a profound psychosocial impact on men who suffer from it¹ and that effective therapy for ED ameliorates that impact.^2,3

Using validated disease-specific quality-of-life instruments of mental health research and general measures of psychological status employed by mental health clinicians and researchers across a variety of health concerns,^1-3 the ExCEED study assessed the effects of ED on an array of psychological dimensions and then evaluated the impact of a broad range of ED treatments on those effects. Phosphodiesterase type 5 (PDE5) inhibitors were the most common treatment option (72% of treated men), with intracavernous injection and vacuum devices reported by 31% and 24% of the treated men, respectively. The mean number of treatments received was 2.3.³

The study linked severity of ED directly to psychological outcomes and other measures, including frequency of ED, intercourse satisfaction, and overall sexual satisfaction. Of the 206 men enrolled, 162 men with evaluable baseline data were grouped by severity of ED.¹ Clinical and demographic characteristics were generally similar between comparison groups except in 3 categories: Compared with men with mild or moderate ED, men with severe ED were significantly more likely to have been diagnosed with ED of multiple etiologies (P <.05), have a history of prostate cancer (P <.01), and have no regular sexual partner (P <.05).¹ Except for marital functioning, marital happiness, and mental health index, men with severe ED also differed from other groups on the psychological measures: less belonging/greater loneliness (P <.05), less positive affect (P <.05), greater depression (P <.01), less sexual confidence (P <.0001), and poorer sense of well-being (P <.05).¹ In multivariate analysis, the psychological characteristic most closely associated with severe ED was poorer sexual self-confidence.^1,2 Thus, severe ED is linked to impairment across a broader range of psychosocial domains than previously appreciated.

After baseline assessment, patients were offered treatment or scheduled for further assessment according to their clinical situation.² Response was defined as an improvement of at least 4 points in International Index of Erectile Function (IIEF) erectile function scores after 12 months of treatment. Of the 153 patients with complete information, 40 responded to treatment, 49 did not respond, and 64 received no treatment.² Treatment responders experienced significant improvements over time in sexual confidence (P <.01), with a trend toward greater improvement in men with the most severe ED.² Modest improvements or no changes were seen in the other psychological outcomes, whereas nonresponders worsened slightly in some parameters.² The small number of patients in the study may have impeded finding statistically significant differences in more psychological domains.²

Results of the ExCEED study underscore the importance of diagnosing and treating ED. The most widely prescribed therapies for ED are the PDE5 inhibitors, which are highly effective and safe for most men.^4-6 Clinicians should be aware of the psychosocial effects of ED and offer men assistance, including counseling and pharmacotherapy, or encourage men for whom oral therapies fail, to seek second-line therapies as appropriate.³ Larger randomized trials to further evaluate the effects of treatment on psychological outcomes are warranted, as are studies of short-term psychosexual counseling combined with medical interventions for ED.

References

1. Latini DM, Penson DF, Wallace KL, Lubeck DP, Lue TF. Clinical and psychosocial characteristics of men with erectile dysfunction: baseline data from ExCEED™.
   J Sex Med. 2006;3:1059-1067.

2. Latini DM, Penson DF, Wallace KL, Lubeck DP, Lue TF. Longitudinal differences in psychological outcomes for men with erectile dysfunction: results from ExCEED™.
   J Sex Med. 2006;3:1068-1076.

3. Latini DM, Penson DF, Lubeck DP, Wallace KL, Henning JM, Lue TF. Longitudinal differences in disease specific quality of life in men with erectile dysfunction: results from the Exploratory Comprehensive Evaluation of Erectile Dysfunction Study. J Urol. 2003;169:1437-1442.

4. Cialis [package insert]. Indianapolis, Ind: Lilly ICOS LLC; 2007.

5. Levitra [package insert]. West Haven, Conn: Bayer Pharmaceuticals Corp.; 2005.

6. Viagra [package insert]. New York, NY: Pfizer Inc; 2006.