Vacuum pump (SOMAerect) Clinical Evidence
HCPC: PH80026 | ISSM: M.37761
Written by: Joshua Hearne-Wilkins, Urology Specialist & Independent Nurse Prescriber (NMC: 11l00400e)
Last clinically reviewed:
Published:
Next review due:
Clinical governance statement
All treatments undertaken by MansMatters (Shockwave Clinics Ltd) are subject to clinical review before they are introduced into practice and at regular intervals thereafter. This review considers the safety profile of each intervention, including contraindications and adverse effects as specified in the manufacturer’s instructions for use or the Summary of Product Characteristics; the regulatory status of each medical device and medicinal product; the position of current UK and European clinical guidance, including the European Association of Urology (EAU), the National Institute for Health and Care Excellence (NICE) and the British Association of Urological Surgeons (BAUS); the qualifications and scope of practice of the treating clinicians; the stage and severity of the condition being treated; and the requirements for informed consent. Each patient is assessed individually, and treatment is offered only where it is clinically appropriate.
The basis of clinical evidence
Clinical evidence is derived from several sources, which carry different weight. Systematic reviews and meta-analyses pool the results of multiple studies and provide the highest level of evidence. Randomised controlled trials, including sham-controlled trials, compare a treatment against a control group under defined conditions. Prospective and retrospective cohort studies, published in peer-reviewed journals, describe outcomes in defined groups of patients over time, and the replication of results by independent research groups in different countries strengthens confidence in a finding. Laboratory and mechanistic studies explain how a treatment is thought to act. In-clinic observational studies and structured outcome audits record the results achieved in routine practice and contribute to the developing evidence base, particularly for newer and combined treatments. Long-term follow-up establishes the durability of results and the safety of a treatment over time.
The evidence relevant to this treatment is summarised below. All citations are hyperlinked to the original source.
Is it safe?
Medical vacuum erection devices have been in clinical use since the 1980s and are classified as medical devices in the UK, the EU and the United States. The SOMAerect is CE-marked, listed in the NHS Drug Tariff and has a vacuum limiter, a quick-release valve and constriction rings with wide release tabs. We fit the device in clinic and train every patient personally. Common side effects are temporary bruising or small red spots, a cool or bluish appearance while the ring is on, numbness and mild discomfort. The constriction ring must never be worn for more than 30 minutes, in line with BAUS and EAU guidance (BAUS leaflet 2024). It isn’t suitable if you have a bleeding or clotting disorder, sickle cell disease, unexplained priapism or impaired penile sensation; men taking anticoagulants are assessed individually.
What the evidence shows
A 2025 meta-analysis of 18 studies (1,065 men whose ED had not responded to other treatment) found that vacuum devices worked for 80% of men: 84.5% after prostate surgery, 73% with diabetes and 71.8% after spinal injury (Zhang et al., Int J Impot Res 2025). In a 29-month study of 216 men, 82 to 84% of patients and 87 to 89% of partners were satisfied (Cookson and Nadig, J Urol 199336059-7)). A 2025 meta-analysis found that adding a vacuum device to tablets improved erectile function scores by a further 4.19 points (Theodorus et al., Arch Ital Urol Androl 2025).
Guidelines and regulation
Vacuum devices are recommended by every major urological body. The European Association of Urology recommends them for men who want non-invasive, drug-free treatment and notes their role in preserving length after prostate surgery (EAU Guidelines 2026); the American Urological Association advises that men should be told about them (AUA Guideline 2018); and the 5th International Consultation on Sexual Medicine found them effective as primary or combination treatment in every population studied (Wang et al., Sex Med Rev 2025). Treatment is supervised by registered clinicians in a clinic registered with the Care Quality Commission.
Independent research
The evidence comes from independent teams in the United States, Europe and Asia over more than thirty years, including Vanderbilt University, the Cleveland Clinic and Houston (Yuan et al., Int J Impot Res 2010). Three independent studies after prostate surgery found that early daily use preserves penile length (Raina et al., Int J Impot Res 2006; Köhler et al., BJU Int 2007; Dalkin and Christopher, Int J Impot Res 2007).
How the vacuum pump compares
A vacuum device works whatever the cause of erectile dysfunction and has no drug interactions. It is non-invasive and inexpensive over time compared with injections. It works well alongside other treatments: in diabetic men who had not responded to tablets, a vacuum device combined with focused shockwave produced a meaningful improvement in 66.7% of men (Tao et al., Front Endocrinol 2022).
How the vacuum pump is thought to work
The cylinder creates negative pressure that draws blood into the erectile tissue, and the ring holds it there. Regular use also oxygenates the tissue: one application raised oxygen saturation in the erectile tissue by about 55% (Welliver et al., J Sex Med 2014), and in an animal model daily use reduced scarring and preserved smooth muscle (Yuan et al., Eur Urol 2010). This is why we use it between treatment sessions.
Long-term results and our experience
Satisfaction in long-term users is 70 to 85% (Cookson and Nadig 199336059-7)). Proper fitting and training help men continue in a dedicated device clinic, erectile function scores after prostate surgery rose from 11.3 to 16.7 (Nason et al., Int J Impot Res 2016). We have used vacuum therapy since 2019 and record outcomes for every patient.
Who is most likely to benefit
Men with diabetes, cardiovascular disease or erectile dysfunction after prostate surgery; men who prefer a drug-free option or cannot take tablets; men on a shockwave or multimodal programme, as an adjunct between sessions; and men who want to preserve length after prostate surgery. It is not suitable for men with the conditions listed under "Is it safe?".
Before your treatment
Your clinician will review your medical history and medication, fit the correct cylinder and ring size, demonstrate the technique and supervise your first use. You will be asked to give your consent before treatment begins, and you will receive written instructions, the 30-minute ring rule and a direct contact for questions.
Further clinical trials and reviews
The following peer-reviewed trials and reviews are also relevant. Each is linked to the original source.