INTRODUCTION: Physical activity (PhA) has proven to be a protective factor for normal erectile function in numerous epidemiological studies. AIM: The aim of this study was to establish if PhA could have a therapeutic role in the treatment of erectile dysfunction (ED). METHODS: This was a randomized, open-label study. A total of 60 patients complaining of ED were studied. Patients were assessed at baseline and after 3 months of study treatment. At baseline, patients were randomized to receive phosphodiesterase type 5 inhibitor (PDE5i) alone (group A) or PDE5i plus regular (>/=3 hours/week), aerobic, non-agonistic PhA (group B). MAIN OUTCOME MEASURES: All subjects completed the International Index of Erectile Function (IIEF-15) questionnaire and performed total testosterone (TT). RESULTS: Mean PhA was 3.4 hours/week in group B vs. 0.43 in group A; mean energy expenditure in group B was 1,868 kcal/ week or 22.8 metabolic equivalent (MET)/week. IIEF restoration of ED occurred in 77.8% (intervention group) vs. 39.3% (control) (P < 0.004). The IIEF-15 score resulted in statistical improvement in intervention group in all the domains but one (orgasm): erectile function 24.7 vs. 26.8 (P = 0.003); confidence (Q15) 3.53 vs. 4.07 (P = 0.006); sexual desire 6.46 vs. 7.18 (P = 0.028); intercourse satisfaction 9.85 vs. 11.25 (P = 0.001); total satisfaction 7.17 vs. 8.07 (P = 0.009); total score 56.2 vs. 61.07 (P = 0.007). TT was statistically similar in the two groups; separate analysis in each group showed statistical increase in group B 4.24 vs. 4.55 (P = 0.012). At multivariate logistic regression analysis, PhA was the only independent variable for normal erection (P = 0.010) (95% confidence interval [CI] 0.036-0.643), higher sexual satisfaction (P = 0.022) (95% CI 0.084-0.821) and normal total IIEF-15 score (P = 0.023) (95% CI 0.85-0.837). CONCLUSION: In this randomized controlled pilot study, PDE5i plus PhA was more effective than PDE5i alone in the treatment of ED.
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