Is the vacuum erectile device suitable for treating erectile dysfunction? A systematic review and meta-analysis exploring the evidence gap.

INTRODUCTION

VED is a handheld pump that creates negative pressure around the penis to draw blood into the corpora cavernosa. Although included in guidelines as a noninvasive option, its uptake is limited by fragmented evidence. Current Grade C recommendations are largely based on post-prostatectomy studies, and no systematic review/meta-analysis has evaluated VED across other ED etiologies (diabetic, cardiovascular, idiopathic) or compared it head-to-head with pharmacotherapy using the IIEF.

METHODS

We searched PubMed, ScienceDirect, and Cochrane Library using relevant keywords to identify studies assessing VED's effects on erectile dysfunction patients. The primary outcome we assessed in this systematic review was erectile function based on the International Index of Erectile Function (IIEF). Study quality was assessed using the Revised Cochrane Risk of Bias tool (RoB2) for Randomized Controlled Trial (RCT) studies and using ROBINS-I for non-RCT studies. Meta-analyses were conducted using Review Manager 5.4.

RESULTS

The meta-analysis results of this study showed that when VED was used as a single therapeutic modality compared with Phosphodiesterase-5 (PDE5) inhibitors (PDE5Is), there was no significant difference (p=0.77). However, when compared with the placebo group (no intervention), VED provided significantly better outcomes [MD: 4.44 (95% CI: 3.04-5.84) p<0.001). Similarly, when VED was combined with PDE5i, its effectiveness was significantly better than PDE5i therapy alone [MD: 4.19 (95% CI: 0.81-7.57; p<0.001)]. In terms of safety, VED is also relatively safe and has mild and reversible side effects.

CONCLUSIONS

VED is effective as a therapy either alone or as an adjunct to PDE5i therapy in patients with erectile dysfunction.