Reviews - Andrology
Vol. 97 No. 4 (2025)
https://doi.org/10.4081/aiua.2025.14328

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

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Received: 6 September 2025
Accepted: 4 October 2025
Published: 27 October 2025
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erectile dysfunction, meta-analysis, vacuum erectile device

Authors

Alymin Rustandy Theodorus
Grestelina Hospital, Makassar, Indonesia.
Ahmad Taufik Fadillah Zainal
ahmadtaufik2014004@gmail.com
https://orcid.org/0000-0002-3480-7692 (unauthenticated)
Division of Urology, Department of Surgery, Faculty of medicine, Hasanuddin University, Makassar, Indonesia.
Moh Anfasa Giffari Makkaraka
https://orcid.org/0000-0003-1179-5366 (unauthenticated)
Division of Urology, Department of Surgery, Faculty of Medicine, Hasanuddin University, Makassar, Indonesia.
Akhmad Zani Tasir M
Faculty of Medicine, Hasanuddin University, Makassar, Indonesia.
Revina Raissa Gunawan
Faculty of Medicine, Hasanuddin University, Makassar, Indonesia.
Muhammad Fakhri
https://orcid.org/0009-0003-7191-2576 (unauthenticated)
Faculty of Medicine, Universitas Muslim Indonesia, Makassar, Indonesia.

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.

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Is the vacuum erectile device suitable for treating erectile dysfunction? A systematic review and meta-analysis exploring the evidence gap. (2025). Archivio Italiano Di Urologia E Andrologia, 97(4). https://doi.org/10.4081/aiua.2025.14328
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