Effect of sildenafil on middle-aged sexually active males with no erectile complaints: a randomized placebo-controlled double-blind study.

BACKGROUND

In clinical practice, we commonly encounter sexually healthy males who use phosphodiesterase type 5 (PDE5) inhibitors and report a beneficial effect to their sex life.

OBJECTIVE

In this study, we aimed to evaluate in a controlled manner the true effect of sildenafil 50 mg on the quality of sexual life (QSL) in a group of sexually active males who do not have erectile complaints.

DESIGN, SETTING, AND PARTICIPANTS: This prospective, placebo-controlled, double-blind, crossover study included sexually active middle-aged males who were never evaluated/treated for erectile dysfunction (ED) and who had an International Index of Erectile Function (IIEF) Erectile Function (EF) Domain score > or = 22. The study included four visits in which subjects randomly received six tablets of sildenafil 50mg or placebo in a crossover manner.

MEASUREMENTS

Assessment of efficacy was performed by subjects filling out the following QSL questionnaires: the Self-Esteem and Relationship Questionnaire (SEAR), the IIEF, the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), and additional questions regarding sexual performance (SAQ).

RESULTS AND LIMITATIONS

From a group of 65 screened subjects, 47 were eligible for analysis (28 without ED and 19 with mild ED). Average age was 52.1+/-10, mostly married (88%), with an IIEF-EF Domain score of 25.6+/-3.1. We found significant differences between the sildenafil vs placebo groups in the EDITS (70.8+/-18 vs 60.3+/-19, p=0.013), SEAR (57.6+/-1 vs 51+/-1. p<0.0001), and IIEF-EF Domain score (25.1+/-4.8 vs 23+/-5.3, p=0.013). All of our structured questionnaires showed significant improvement in the treated group. We did not find significant differences between the groups in the total IIEF score. We also performed individual analysis in the subgroup of subjects (mild ED vs normal EF), and no significant differences were demonstrated in the results of these groups with regard to total scores on all questionnaires employed.

CONCLUSIONS

This is the first placebo-controlled study performed on a selected group of individuals suggesting that middle-aged subjects without complaints of ED may have real benefit when using sildenafil. This study provides some preliminary data regarding the use of a phosphoesterase type 5 inhibitor (PDE5-I) in this unexplored population, but more data are needed in order to seriously consider extending their use in these males and perhaps in the younger population.