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

International Journal of Impotence Research (2025)Cite this article

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Abstract

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.

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Fig. 1
Fig. 2: Pooled data of VED efficacy based on subgroups stratified by etiologies.
Fig. 3: Pooled data of VED efficacy based on subgroups stratified by etiologies after removing the heterogenous studies or study arms.
Fig. 4: Results of meta-regression.
Fig. 5: Assessment of publication bias.

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Data availability

The datasets analyzed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

Authors appreciate all investigators and researchers of included studies, and thank the assistance of Ruicheng Wu of West China Hospital.

Funding

This work was supported by the Natural Science Foundation of China (No. 824B2017).

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Author notes

  1. These authors contributed equally: Fuxun Zhang, Zhirong Luo.

Authors and Affiliations

  1. Department of Urology, Tangdu Hospital, Fourth Military Medical University, Xi’an, Shaanxi, China

    Fuxun Zhang, Zhirong Luo, Qi Xue, Xuyan Guo, Wei Zhang, Geng Zhang & Yong Jiao

  2. Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu, Sichuan, China

    Yang Xiong

  3. Division of Surgery & Interventional Science, University College London, London, UK

    Uzoamaka Adaobi Okoli

  4. Basic and Translational Cancer Research Group, Department of Pharmacology and Therapeutics, College of Medicine, University of Nigeria, Ibadan, Enugu State, Nigeria

    Uzoamaka Adaobi Okoli

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Contributions

(I)Conception and design: FZ; YJ; (II)Administrative support: GZ; YJ; (III)Provision of study materials or patients: FZ; ZL; QX; XG; (IV)Collection and assembly of data: FZ; ZL; QX; YX; XG; (V)Data analysis and interpretation: FZ; ZL; QX; WZ; YX; (VI) Manuscript writing: FZ; UAO; YJ; (VII)Final approval of manuscript: FZ; ZL; QX; XG; WZ; YX; UAO; GZ; YJ. All named authors meet the ICMJE criteria for authorship in this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

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Correspondence to Geng Zhang or Yong Jiao.

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Zhang, F., Luo, Z., Xue, Q. et al. Efficacy of vacuum erectile device in refractory erectile dysfunction: a systematic review and meta-analysis. Int J Impot Res (2025). https://doi.org/10.1038/s41443-025-01102-w

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