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5 peer-reviewed papers · original texts

Published research on vacuum erection therapy

The five publications below are peer-reviewed papers examining the efficacy and safety of vacuum erection therapy (VED): two systematic reviews, one meta-analysis, one prospective clinical study and one narrative review. Each is published with its original PDF and the key passages quoted in the original English.

What this is evidence of — and what it is not

These papers examine the method; none of them is an independent clinical study of the Active3® device itself. The devices used in the research come from different manufacturers; what they share is the working principle — negative pressure in a cylinder and a constriction ring. The results should therefore be read as an indication about the method, not as a promise about this product.

On this page

  1. 01Feng Qin et al. 2018 — Penile rehabilitation after prostate surgery
  2. 02Melianthe Nicolai et al. 2021 — Penile rehabilitation after prostate surgery
  3. 03Daniel Brison et al. 2013 — Overall efficacy of the method
  4. 04Bogdan Pajovic et al. 2017 — Diabetes-related erectile dysfunction
  5. 05Miro Kasum et al. 2018 — Neurogenic erectile dysfunction
01Penile rehabilitation after prostate surgery

Early vacuum therapy after radical prostatectomy: a systematic review and meta-analysis

The Early Use of Vacuum Therapy for Penile Rehabilitation After Radical Prostatectomy: Systematic Review and Meta-Analysis

The publication with the highest level of evidence on this list. By pooling data from six randomized trials, it quantifies the effect of starting vacuum therapy early after prostate cancer surgery on both erectile function and the preservation of penile length.

Authors
Feng Qin, Shuzhen Wang, Jinhong Li, Changjing Wu, Jiuhong Yuan
Published in
American Journal of Men's Health 2018;12(6):2136–2143
Design
Meta-analysis — pooled data from 6 randomized controlled trials
Participants
273 men (162 early vacuum therapy, 111 controls)

Findings

  • In the early vacuum therapy group, the IIEF-5 (erectile function) score was on average 4.76 points higher than in the control group (95% confidence interval 3.28–6.24; p < 0.00001).
  • When vacuum therapy was combined with a PDE-5 inhibitor, an additional improvement of 3.84 points was seen compared with a PDE-5 inhibitor alone (95% CI 2.93–4.74).
  • Men who started one month after surgery achieved results 9.20 points better than those who started four months after surgery — the most striking finding, showing that timing is decisive.
  • Penile length and penile rigidity measurements also improved significantly compared with the control group.
  • None of the six trials reported serious adverse events. Observed effects were limited to transient discomfort (9.9%) and penile bruising (3.6%).

Limitations of the study

  • The total sample of 273 men is small; the authors state that the results should therefore be interpreted with caution.
  • None of the six trials was double-blind and placebo-controlled; the authors rate the methodological quality as "low".
  • The study does not provide enough data to say whether vacuum therapy is superior or equivalent to PDE-5 inhibitors — it only shows that combining the two is better than medication alone.

Original text · English

This study suggests that initiating an early use of vacuum therapy appears to be an effective strategy for improving ED and penile shrinkage in post-RP men.
Moreover, when vacuum therapy are combined with PDE-5i, the benefits of penile rehabilitation seem to be significantly enhanced.
The severity of the adverse events was mild and easy to control in post-RP men.
As this study is conducted on a small sample, the results need to be interpreted with caution.
Quoted section: Conclusion. Reproduced verbatim from the original document.
Open the original paper (PDF)Publisher record · DOI 10.1177/1557988318797409
02Penile rehabilitation after prostate surgery

Penile rehabilitation and treatment options after radical prostatectomy and radiotherapy: a systematic review

Penile Rehabilitation and Treatment Options for Erectile Dysfunction Following Radical Prostatectomy and Radiotherapy: A Systematic Review

A recent review that positions vacuum therapy not on its own but among all penile rehabilitation options. The author team includes two urology centres from Türkiye. The site's "the device is not the only solution" approach rests largely on this publication.

Authors
Melianthe Nicolai, Ahmet Urkmez, Selcuk Sarikaya, Mikkel Fode, Marco Falcone, Maarten Albersen, Murat Gul, Georgios Hatzichristodoulou, Paolo Capogrosso, Giorgio Ivan Russo
Published in
Frontiers in Surgery 2021;8:636974
Design
Systematic review — only randomized controlled trials included (PRISMA)
Participants
Men after prostate cancer treatment

Findings

  • The efficacy of vacuum erection devices as a first-line treatment option for erectile dysfunction is considered well established.
  • There is evidence that vacuum devices may help prevent penile shortening and preserve erectile function after radiotherapy; however, the authors state explicitly that no high-quality evidence exists yet on this point.
  • Of the two randomized trials testing post-operative vacuum therapy, the study by Köhler et al. found significantly higher IIEF scores at 3 and 6 months in the early-start group; by the end of the first year the difference between the groups had disappeared (p = 0.75).
  • In animal studies, vacuum therapy reduced hypoxia-inducible factors and increased endothelial NO synthase expression and the smooth muscle/collagen ratio — the likely mechanism of its protective effect on tissue.
  • The authors' conclusion is not a single method but a multimodal approach: pelvic floor physiotherapy, a vacuum device, regular exercise and medication used together.

Limitations of the study

  • There is not yet a clear guideline for penile rehabilitation; the authors stress that the evidence is generally "scarce".
  • In the Köhler study the advantage of an early start was lost by the end of the first year — a long-term superiority of early vacuum therapy has not been demonstrated.
  • Neither group reported spontaneous erections sufficient for intercourse at the 1-year follow-up.

Original text · English

The effectiveness of vacuum erectile devices as first-line treatment option of erectile dysfunction is well-established.
Although, currently, no high-quality evidence exists, ongoing research suggests in addition to early PDE5i, VEDs may be effective in preventing penile shrinkage and preserving the EF in the context of RT.
In order to maximize chances of return to spontaneous erections or maintenance of erections after nsRP as well as RT, a combination of pelvic floor physiotherapy, vacuum device therapy, PVS, regular exercise and/or yoga may be recommended to be used together with pro-erectile medication.
An holistic and multimodal approach may be the key to recovery of sexual function following RP or RT in patients with localized PCa.
Quoted section: Vacuum erection devices section. Reproduced verbatim from the original document.
Open the original paper (PDF)Publisher record · DOI 10.3389/fsurg.2021.636974
03Overall efficacy of the method

The resurgence of the vacuum erection device in the treatment of erectile dysfunction

The Resurgence of the Vacuum Erection Device (VED) for Treatment of Erectile Dysfunction

The source that most comprehensively explains why vacuum therapy is still in use. It traces the device's development from 1874 to the present, then tabulates studies on organic, psychogenic, diabetic and post-operative erectile dysfunction. The site's statement about "more than thirty years of use" comes from this review.

Authors
Daniel Brison, Allen Seftel, Hossein Sadeghi-Nejad
Published in
The Journal of Sexual Medicine 2013;10:1124–1135
Design
Review — history, literature and current use of the method
Participants
Men with erectile dysfunction of various causes

Findings

  • Vacuum erection devices have been approved in the USA since 1982 and are accepted by the American Urological Association for the treatment of erectile dysfunction.
  • In Witherington's survey of 1,517 men who used the device between 1974 and 1987, 92% of respondents reported an erection sufficient for intercourse or close to it; no serious adverse events were reported.
  • In Nadig's study of 35 men diagnosed with organic impotence, 32 (91%) achieved rigidity sufficient for vaginal penetration; at 8–22 months of follow-up, 24 of 30 men were using the device regularly.
  • In diabetes-related erectile dysfunction: 75% satisfactory intercourse after two months in Price's 44-patient study; 70% good response in Israilov's study of 162 sildenafil non-responders.
  • After prostate surgery: in Raina's randomized study of 109 patients, loss of length and girth was reported by 23% of device users versus 63% of non-users.
  • The authors' verdict: the device should be considered "an attractive second-line therapy", and should be considered first-line in post-operative penile rehabilitation and in men who cannot use a PDE-5 inhibitor.

Limitations of the study

  • The review is based on a retrospective literature search rather than a systematic method; it produces no pooled quantitative result.
  • Many of the studies cited date from the 1980s–1990s, have small samples and lack controls.
  • The authors also list the device's known drawbacks: pivoting at the base of the penis, bluish discolouration, and the erection feeling cooler because of restricted blood flow.

Original text · English

The VED has continued to show efficacy for treatment of ED due to various etiologies and should be considered an attractive second-line therapy.
In select cases such post-prostatectomy penile rehabilitation, as well as in men who cannot use a PDE5i, the vacuum device should be considered first-line treatment.
Early penile rehabilitation after surgery for prostate cancer with the VED appears to improve erectile function and penile length. Adverse events are transient and not serious.
Quoted section: Conclusion. Reproduced verbatim from the original document.
Open the original paper (PDF)Publisher record · DOI 10.1111/jsm.12046
04Diabetes-related erectile dysfunction

Vacuum erection device in organic erectile dysfunction and penile vascular differences between type 1 and type 2 diabetes

Vacuum erection device in treatment of organic erectile dysfunction and penile vascular differences between patients with DM type I and DM type II

The only prospective patient study on the list, and focused directly on diabetes. All participants had previously failed to respond to PDE-5 inhibitors, so the study offers a concrete example of what vacuum therapy provides when medication does not work.

Authors
Bogdan Pajovic, Antonio Dimitrovski, Nikola Fatic, Milos Malidzan, Marko Vukovic
Published in
The Aging Male 2017;20(1):49–53
Design
Prospective clinical study — 6-month follow-up
Participants
50 men with diabetes (aged 35–67; 30 type 1, 20 type 2), 41 of whom completed the study

Findings

  • After six months, penile engorgement allowed normal sexual intercourse in 35 of 41 patients (85%); 6 patients (15%) did not achieve sufficient rigidity.
  • Significant improvement was seen in three separate items of the IIEF questionnaire in both diabetes groups.
  • Cavernous artery peak systolic velocity (PSV) was markedly lower in patients with type 1 diabetes (19.7 cm/s vs 34.1 cm/s) — i.e. the risk of arterial insufficiency is higher in type 1.
  • Vascular insufficiency was also more severe in the group with high blood glucose and HbA1c values, confirming the link between poor glycaemic control and vascular impairment.
  • The authors' conclusion: the vacuum device may be a good alternative for patients who decline or do not respond to oral medication.

Limitations of the study

  • There is no control group; all participants used the device.
  • The sample of 50 is small, and 9 patients withdrew in the first two months — reasons included partner dissatisfaction and relationship problems.
  • Two patients reported severe pain when applying the ring, two reported coldness of the penis, and three reported petechial (pinpoint) bleeding. The patients with bleeding had not observed the 30-minute limit.
  • People taking anticoagulants were excluded, so the results do not apply to this group.

Original text · English

The aim of this study is to investigate changes in the vascular system and hemodynamics between patients with organic erectile dysfunction (ED) (DM type I and II), as well as to compare the quality of sexual life between those two groups after the treatment with vacuum erection device (VED).
There was significant improvement in three items of IIEF after six months of treatment among both groups of examinees.
Patients with DM type I had more serious risk for development of arteriogenic ED.
VED could be a good alternative therapy for patients who denied peroral therapy.
Quoted section: Abstract. Reproduced verbatim from the original document.
Open the original paper (PDF)Publisher record · DOI 10.1080/13685538.2016.1230601
05Neurogenic erectile dysfunction

Improving sexual and reproductive function in men with spinal cord injury

Improvement of Sexual and Reproductive Function in Men with Spinal Cord Lesion

We included this review not because it portrays vacuum therapy favourably but because it states its limits plainly. It reports that satisfaction with vacuum devices among men with spinal cord injury is lower than with other methods. It is the clearest source showing that the device does not give the same result in every patient group.

Authors
Miro Kasum, Slavko Orešković, Mario Kordić, Ermin Čehić, Dinko Hauptman, Emina Ejubović, Albert Lila, Gordana Smoljić
Published in
Acta Clinica Croatica 2018;57:149–156
Design
Review
Participants
Men with spinal cord lesion (SCL)

Findings

  • Erectile dysfunction after spinal cord injury can be managed successfully with PDE-5 inhibitors, intracavernosal injections, vacuum devices and penile prostheses.
  • However, in this patient group satisfaction rates with vacuum erection devices have been reported to be lower than with other methods.
  • Intracavernosal injections report 80% success in this group — a higher rate than vacuum therapy.
  • The review also confirms the device's working principle: a rigid cylinder into which the penis is inserted and a constriction band at the base create the negative-pressure mechanism that draws blood into the penis and keeps it there.

Limitations of the study

  • The review does not focus on vacuum therapy; the method is covered in a short section among options for sexual and reproductive function.
  • The low satisfaction with vacuum devices rests on a single source (Denil et al.); no pooled data are presented.
  • The findings are specific to spinal cord injury and cannot be generalized to other patient groups.

Original text · English

Vacuum erection devices consist of a rigid cylinder for penile inserting and a constriction band over the base of the penis, forming the mechanism of negative pressure to draw and maintain blood in the penis.
Nevertheless, in patients with SCL, lower satisfaction rates with vacuum erection devices have been reported compared to other methods for erectile dysfunction.
Despite common impairments of reflexogenic and psychogenic erections in patients with SCL, erectile dysfunction can be managed successfully by the use of phosphodiesterase-5 inhibitors, intracavernosal injections, vacuum devices and penile prostheses.
Quoted section: Vacuum devices section and conclusion. Reproduced verbatim from the original document.
Open the original paper (PDF)Publisher record · DOI 10.20471/acc.2018.57.01.19

About the publications

Why these five papers?

A positive result was not the only criterion for this list. We chose to bring together the highest level of evidence on the method (a meta-analysis), the most recent guideline discussion (a systematic review), a study conducted directly on patients, and a source that shows the method’s limits. The fifth paper — a review on spinal cord injury — reports that satisfaction with vacuum therapy remains low in some patient groups; that is exactly why it belongs on this page.

Each paper has a "Limitations of the study" section. Constraints such as small sample size, lack of a control group and absence of blinding are taken from the papers’ own text; they should be weighed together with the results.

Certificates on a separate page

This page collects scientific publications on the method. The device’s own CE declaration of conformity, EC certificate, ISO 13485 quality certificate and MDR transition letter are on a separate page — originals shown, with an English translation alongside the German passages.

Certificates and declarations of conformity

If you want to start from the basics

The articles in the guide cover the same topics independently of the device: the physiology of erection, penile rehabilitation after prostate surgery, and erectile dysfunction caused by diabetes.

Go to the guide

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Let’s talk about whether the device suits your situation

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