The Phoenix is a home-use device marketed for erectile dysfunction (ED) treatment using low-intensity shockwave therapy. Unlike oral medications such as sildenafil, which work on demand, the Phoenix aims to improve blood flow and potentially regenerate damaged penile blood vessels through acoustic wave stimulation. Whilst the device is available to purchase directly in the UK without prescription, it is not commissioned for routine NHS use. NICE guidance states that evidence on shockwave therapy for ED is inadequate in quality and quantity, recommending use only with special clinical governance arrangements. Men experiencing erectile dysfunction should consult their GP for proper assessment before considering any treatment device.

What Is the Phoenix Device for Erectile Dysfunction?

The Phoenix is a home-use medical device designed to treat erectile dysfunction (ED) through low-intensity extracorporeal shockwave therapy (Li-ESWT). This non-invasive treatment delivers acoustic waves to penile tissue with the aim of improving blood flow and potentially regenerating damaged blood vessels. The device is marketed directly to consumers in several countries, including the UK, and can be purchased without a prescription. It is not currently commissioned for routine use by the NHS.

The underlying principle of shockwave therapy for ED is based on the concept of neovascularisation—the formation of new blood vessels. Acoustic waves are thought to stimulate the release of growth factors and promote angiogenesis in penile tissue, particularly in men whose erectile dysfunction stems from vascular causes. The Phoenix device typically requires multiple treatment sessions over several weeks, with users applying the device to specific areas of the penis according to the manufacturer's instructions for use (IFU).

It is important to distinguish between the Phoenix and other ED treatments. Unlike oral phosphodiesterase-5 (PDE5) inhibitors such as sildenafil (Viagra) or tadalafil (Cialis), which work acutely to facilitate erections when sexual stimulation occurs, shockwave therapy aims to address underlying vascular pathology. The device is positioned as a potential treatment option rather than an on-demand solution. However, prospective users should be aware that home-use devices may deliver different types of acoustic waves (radial or pressure waves) and energy levels compared to the focused Li-ESWT used in most clinical trials, and the evidence base for home-use devices differs substantially from that for clinic-based Li-ESWT.

Any medical device sold in the UK should carry appropriate UKCA or CE marking and be registered with the Medicines and Healthcare products Regulatory Agency (MHRA). It is important to understand that device registration does not demonstrate clinical efficacy. NICE Interventional Procedures Guidance on low-intensity extracorporeal shockwave therapy for erectile dysfunction states that current evidence on safety is limited and evidence on efficacy is inadequate in quality and quantity. NICE recommends that Li-ESWT for ED should only be used with special arrangements for clinical governance, consent, and audit or research. Men considering this treatment should discuss it with their GP as part of a comprehensive management plan.

Clinical Evidence and Effectiveness

The clinical evidence for low-intensity shockwave therapy in erectile dysfunction has evolved over the past decade, though most published studies have examined clinic-based protocols with medical supervision rather than home-use devices like the Phoenix. Systematic reviews and meta-analyses of Li-ESWT have shown modest improvements in erectile function scores, particularly in men with mild to moderate vasculogenic ED. Studies typically measure outcomes using validated tools such as the International Index of Erectile Function (IIEF-5) questionnaire.

A 2019 meta-analysis published in European Urology found that Li-ESWT demonstrated statistically significant improvements in erectile function compared to sham treatment, with effects persisting for several months post-treatment. Typical improvements in IIEF-5 scores ranged from 2 to 4 points in responders, with benefits generally lasting up to 6–12 months in men with mild to moderate vasculogenic ED. However, the authors noted considerable heterogeneity in treatment protocols, including variations in energy levels (typically 0.09–0.15 mJ/mm²), number of shockwaves delivered per session (commonly 1,500–3,000), and treatment schedules. The quality of evidence was rated as moderate, and researchers called for larger, well-designed randomised controlled trials.

Key limitations in the current evidence base include:

• Most studies have used clinic-based devices with specified energy densities and treatment parameters under medical supervision

• Long-term efficacy data (beyond 12 months) remain limited

• Optimal treatment parameters have not been definitively established

• Few studies have directly compared home-use devices to clinic-based protocols

• Home-use devices may not replicate the energy densities, wave types, or treatment schedules used in published trials

The Phoenix device specifically has limited peer-reviewed published data. Whilst the manufacturer cites internal studies and user testimonials, independent clinical trials examining this particular device are scarce. NICE Interventional Procedures Guidance concludes that current evidence on the safety of Li-ESWT for ED shows no major safety concerns, but evidence on efficacy is inadequate in quality and quantity. There is no official consensus from NICE, the European Association of Urology, or other authoritative bodies endorsing home-use shockwave devices as first-line therapy for erectile dysfunction. Men considering this treatment should be aware that the evidence for home-use devices is uncertain and may not reflect the outcomes seen with clinic-based Li-ESWT protocols.

Who Can Use the Phoenix Device?

The Phoenix device is primarily marketed towards men with mild to moderate erectile dysfunction, particularly those whose condition has a vascular aetiology. Manufacturers typically suggest the device may be suitable for men who have not responded adequately to oral medications, those seeking to reduce reliance on pharmaceutical treatments, or men wishing to address underlying causes rather than symptoms alone. However, determining suitability requires careful consideration of individual circumstances and underlying health conditions. Evidence for Li-ESWT mainly concerns vasculogenic ED; benefit is uncertain in neurogenic ED or post-prostatectomy erectile dysfunction.

Men who may potentially be considered include those with:

• Vasculogenic ED related to cardiovascular risk factors (diabetes, hypertension, dyslipidaemia)

• Mild to moderate erectile dysfunction (IIEF scores suggesting partial erectile function)

• No contraindications to shockwave therapy

• Realistic expectations about treatment outcomes and timelines

Conversely, certain groups should exercise caution or avoid shockwave therapy. Men with severe erectile dysfunction, particularly those with significant penile fibrosis or anatomical abnormalities, may not be suitable candidates. The device is contraindicated in men with bleeding disorders and individuals with active infections or malignancies in the treatment area. Men with penile implants or those who have undergone recent pelvic surgery should consult their urologist before considering this treatment. Men taking anticoagulant medications should seek medical advice before use, as anticoagulation is a relative contraindication requiring clinician assessment and adherence to the manufacturer's instructions for use.

Crucially, erectile dysfunction can be an early warning sign of cardiovascular disease or other serious health conditions including diabetes, hormonal imbalances, medication side effects, or psychological disorders. Medicines commonly associated with ED include selective serotonin reuptake inhibitors (SSRIs), 5-alpha-reductase inhibitors (finasteride, dutasteride), and some antihypertensives; where appropriate, alternatives may be considered in consultation with a prescriber. Before purchasing any home-use device, men experiencing ED should undergo proper medical assessment through their GP. A comprehensive evaluation should include cardiovascular risk assessment, screening for diabetes (HbA1c), and lipid profile. Measurement of morning total testosterone should be considered where clinical features suggest hypogonadism (such as reduced libido, loss of morning erections, fatigue) or in selected cases; if low, the test should be repeated with a second early-morning sample. Self-treating without proper diagnosis may delay identification of underlying conditions requiring medical intervention. NICE Clinical Knowledge Summary guidance emphasises that ED assessment should be holistic, addressing both physical and psychological factors, and this cannot be adequately achieved through direct-to-consumer device purchases alone.

Potential Side Effects and Safety Considerations

Low-intensity shockwave therapy is generally considered to have a favourable side effect profile compared to more invasive ED interventions. Clinical studies of Li-ESWT have reported minimal adverse events, and serious complications are rare. NICE Interventional Procedures Guidance notes that current evidence shows no major safety concerns, though evidence on efficacy remains limited. However, as with any medical device applied to sensitive tissue, users should be aware of potential side effects and safety considerations specific to home use without medical supervision.

Commonly reported side effects include:

• Mild discomfort or pain during treatment (usually transient)

• Temporary redness or bruising at application sites

• Penile skin sensitivity lasting several hours post-treatment

• Occasional petechiae (small red spots from minor bleeding under the skin)

These effects are typically mild and resolve spontaneously within hours to days. However, incorrect use of the device—such as applying excessive pressure, treating for longer than recommended, or using inappropriate energy settings—could potentially cause tissue damage. Unlike clinic-based treatments where trained healthcare professionals adjust parameters based on patient response, home users must rely on the manufacturer's instructions for use and their own judgement. Users should verify that the device carries appropriate UKCA or CE marking and adhere strictly to the manufacturer's instructions for use, including treatment areas, pressures, and session limits.

More significant concerns relate to the lack of medical oversight when using home devices. Men may inadvertently use the Phoenix whilst having undiagnosed contraindications, such as coagulopathy or vascular malformations. There is also the risk that focusing on device-based treatment may delay seeking appropriate medical care for underlying conditions. For instance, a man attributing ED solely to vascular causes might overlook hormonal deficiencies, medication side effects, or psychological factors that require different interventions.

Safety recommendations include:

• Consulting a GP or urologist before commencing treatment

• Verifying UKCA or CE marking and following the manufacturer's instructions for use precisely

• Discontinuing use if significant pain, bruising, or other concerning symptoms develop

• Seeking medical review if erectile function worsens or if new symptoms emerge

• Maintaining realistic expectations and not delaying proven treatments

Patients should contact their GP promptly if they experience persistent pain, significant bruising, blood in urine or semen, or any signs of infection following device use. Men with cardiovascular disease should ensure their condition is stable and optimally managed before undertaking any ED treatment, as sexual activity itself carries cardiovascular demands. Suspected side effects or problems with the device should be reported via the MHRA Yellow Card scheme (available at yellowcard.mhra.gov.uk or via the Yellow Card app).

NHS and Alternative Treatment Options for Erectile Dysfunction

The NHS offers a comprehensive, evidence-based approach to erectile dysfunction that begins with proper assessment and addresses underlying causes. NICE Clinical Knowledge Summary guidance recommends that ED management should be individualised, considering physical health, psychological factors, relationship issues, and patient preferences. Importantly, the Phoenix device and other home-use shockwave therapy systems are not currently commissioned for routine use by the NHS. NICE Interventional Procedures Guidance states that current evidence on Li-ESWT for ED is inadequate in quality and quantity, and recommends use only with special arrangements for clinical governance, consent, and audit or research.

First-line NHS treatments for erectile dysfunction include:

Oral PDE5 inhibitors: Sildenafil, tadalafil, vardenafil, and avanafil remain the mainstay of ED treatment. These medications enhance the natural erectile response to sexual stimulation by inhibiting the enzyme that breaks down cyclic GMP, thereby promoting smooth muscle relaxation and increased blood flow to the penis. They are effective in approximately 70% of men and are generally well-tolerated. Generic sildenafil is generally available on NHS prescription; other PDE5 inhibitors may be subject to local commissioning policies. The NHS typically prescribes these medications after cardiovascular assessment.

Important contraindications and interactions for PDE5 inhibitors include:

• Absolute contraindications: concurrent use of nitrates (e.g., glyceryl trinitrate, isosorbide mononitrate), nicorandil, or riociguat (risk of severe hypotension)

• Cautions: concomitant alpha-blockers (risk of postural hypotension; dose adjustment and timing may be required)

• Severe cardiovascular disease, recent stroke or myocardial infarction, and certain other conditions require specialist assessment

Men should be advised not to use PDE5 inhibitors if they are taking nitrates or nicorandil, and to inform their GP of all medications before starting treatment. Full prescribing information is available in the British National Formulary (BNF) and MHRA-approved Summaries of Product Characteristics (SmPCs).

Lifestyle modifications: GPs will emphasise the importance of addressing modifiable risk factors including smoking cessation, weight reduction, increased physical activity, reduced alcohol consumption, and optimisation of cardiovascular health. These interventions can significantly improve erectile function and overall health outcomes.

Psychological interventions: For men where psychological factors contribute to ED, referral to psychosexual counselling or cognitive behavioural therapy may be appropriate. Relationship counselling can also be beneficial when ED affects both partners.

For men who do not respond to oral medications or have contraindications to PDE5 inhibitors, second-line treatments are available through specialist urology services. These include intracavernosal injections (alprostadil), intraurethral alprostadil, vacuum erection devices, and, in selected cases, penile prosthesis surgery. Vacuum erection devices are usually available on NHS prescription or via specialist services, subject to local pathways, and have a well-established evidence base.

Men with ED secondary to hypogonadism may benefit from testosterone replacement therapy, though this should only be initiated after appropriate investigation (confirmed low morning total testosterone on two occasions) and under specialist supervision. It is important to note that testosterone therapy alone rarely resolves ED and is not a first-line treatment unless deficiency is confirmed.

When to seek NHS care:

• New onset erectile dysfunction (especially if sudden)

• ED accompanied by cardiovascular symptoms (chest pain, breathlessness)

• Loss of morning erections or reduced libido (suggesting possible hypogonadism)

• Penile deformity, curvature, or painful erections (possible Peyronie's disease)

• Relationship distress related to sexual function

• Inadequate response to over-the-counter or private treatments

• Features suggesting serious underlying disease

The NHS pathway ensures that serious underlying conditions are not missed and that treatment is tailored to individual needs. Whilst devices like the Phoenix may appeal to men seeking non-pharmaceutical options, the lack of robust evidence for home-use shockwave therapy and the absence of routine NHS commissioning mean they should not replace proper medical assessment and proven treatments. Men considering such devices should discuss them with their GP as part of a comprehensive management plan rather than as a substitute for medical care. Further information is available on the NHS website and through NICE Clinical Knowledge Summaries on erectile dysfunction.

Frequently Asked Questions