Combined sildenafil with vacuum erection device therapy in the management of diabetic men with erectile dysfunction after failure of first‐line sildenafil monotherapy

Objective To evaluate the efficacy and safety of combination therapy of sildenafil plus vacuum erection devices in men with type 2 diabetes mellitus with moderate to severe erectile dysfunction who are dissatisfied with the results of using sildenafil alone. Methods The study included 66 diabetes mellitus patients presenting erectile dysfunction for at least 6 months and dissatisfied with the use of 100 mg sildenafil monotherapy. The patients were randomized in two groups. Those in group A ( n = 33) were instructed to use a vacuum erection device only, whereas those in group B ( n = 33) were treated with combination therapy, including sildenafil 100 mg and a vacuum erection device. Erectile function was evaluated subjectively using the I nternational I ndex of E rectile F unction, S exual E ncounter P rofile questionnaire questions 2 and 3 at visit 1 (baseline; study entry), visit 2 (4 weeks after baseline), and visit 3 (12 weeks after baseline; study end). Results There were no significant differences in average patient age, duration of diabetes, duration of erectile dysfunction, baseline I nternational I ndex of E rectile F unction scores, hypertension, blood testosterone, smoking and alcohol consumption between two groups. Mean I nternational I ndex of E rectile F unction scores were significantly higher for group B at the 1‐month (14.86 ± 2.17 vs 12.41 ± 2.63; P < 0.0001) and 3‐months (17.53 ± 2.95 vs 14.29 ± 2.81; P < 0.0001) visits. Men in group B had better successful penetration (73.3% vs 46.6%) and successful intercourse (70% vs 46.6%) at 3 months compared with group A . Conclusion Combined use of sildenafil and vacuum erection device therapy significantly enhances erectile function, and it is well tolerated by diabetes mellitus patients not responding to first‐line sildenafil alone.