New data from a multi-center clinical trial led by investigators at Johns Hopkins School of Medicine demonstrate that use of the ErecAid vacuum erection device to augment PDE5i therapy can greatly improve patient satisfaction.
Investigators at four separate study sites evaluated 69 men aged 36 to 82 with erectile dysfunction (ED) of diverse etiology who had responded inadequately to PDE5i therapy. Study subjects were allowed to continue use of PDE5i’s but were instructed to use the ErecAid device as an adjunct to their current oral medication.
Study subjects were assessed using three validated measurements of erectile function and sexual satisfaction: the international index of erectile function (IIEF-5), the sexual encounter profile (SEP-2 and SEP-3) and the global patient assessment scale (GAPS).
After four weeks of supplemental treatment with ErecAid, the IIEF-5 score improved substantially from a baseline of nine to 17.6 (p<0.001). Moreover, of the 34 subjects unable to achieve an erection satisfactory for intercourse at baseline, 27 subjects (79%) reported erections satisfactory for intercourse following the addition of ErecAid (p<0.001). Finally, of 42 subjects reporting no or slight response to PDE5i at baseline, 31 (74%) reported moderate or great improvement at the end of the four week study (p<0.001). Arthur Burnett, professor of urology at Johns Hopkins School of Medicine and the lead investigator of this trial, said: "This study confirms an earlier trial that many patients can achieve excellent results using ErecAid as an addition to oral PDE5i therapy. Based upon these results, I would encourage physicians treating ED to consider the importance of this approach in their treatment protocols and to discuss this option with their patients."