Efficacy of vacuum erectile device in refractory erectile dysfunction: a systematic review and meta-analysis

Vacuum erection device (VED) as one of the approved therapies for erectile dysfunction (ED) is widely used. However, available evidence of VED efficacy on refractory ED, a condition often unresponsive to phosphodiesterase type 5 (PDE5) inhibitors, is limited. A literature search was performed using PubMed, EMBASE, and the Cochrane Library to identify all clinical trials up to December 2024. The primary outcome was efficacy defined as successful intercourse or intercourse satisfaction after VED intervention, and the secondary outcome was the incidence of most common side effects. The pooled rate with 95% confidence intervals (CI) was selected as the effect size. Heterogeneity was assessed by Cochran's Q test and the I² test. Sensitivity analyses, subgroup analyses and meta-regression were used to explore the sources of heterogeneity. Publication bias was assessed by funnel plots and Egger's test. Data from 1065 patients across 18 studies were analyzed in this meta-analysis. The pooled effect size of VED efficacy was 0.80 (95% CI: 0.76-0.84). Among the different subgroups, the efficacy of VED in ED patients with mixed etiologies, diabetes mellitus, spinal cord injury and radical prostatectomy were 82.9, 73.0, 71.8 and 84.5%, respectively. The most common side effect was penile bruising with a pooled incidence of 24.3%. ED patients with spinal cord injury may have a higher risk of penile bruising (31.4%). Meta-regression suggested that the publication date and patients' age may affect the outcome. No significant publication bias was detected. In conclusion, VED is an effective adjunct for improving the intercourse success rate and patient satisfaction in refractory ED. Future large randomized controlled trials with standardized objective measurements and longer follow-up durations are warranted.