Focused Shockwave Therapy (f-ESWT) Clinical Evidence

Mr Leon Almashan
Clinically Reviewed By: Mr Leon Almashan, BSc (Hons), Clinical Director and Men’s Health Specialist
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?

All of our Focused Shockwave Therapy (f-ESWT) devices are made by Storz Medical AG and are CE-marked medical devices; we use the DUOLITH SD1 T-TOP ultra with the C-ACTOR handpiece. Treatment is non-invasive, needs no anaesthetic and has no downtime. A 2025 Cochrane review of randomised trials found no difference in treatment-related side effects between shockwave and sham treatment across 20 trials and 1,400 men, and no serious adverse event in any trial (Ergun et al., Cochrane 2025). Mild tingling, tenderness or redness of the skin can occur and usually settles within a day. It isn’t suitable if you have a bleeding or clotting disorder, a penile implant, or an infection or tumour in the treatment area; men taking blood-thinning medication are assessed individually.

What the evidence shows

Focused shockwave therapy is the non-surgical, drug-free ED treatment with the largest body of randomised evidence. The 2025 Cochrane review pooled 21 sham-controlled trials (1,357 men) and found that men treated with shockwave scored on average 3.89 points higher on the IIEF erectile function scale within three months, and 5.25 points higher beyond three months, than men given sham treatment (Ergun et al., Cochrane 2025). In a double-blind trial of 70 men with moderate ED, 79% of treated men reached a clinically meaningful improvement, against none on sham (Kalyvianakis et al., J Urol 2022). In men who no longer responded to tablets, 54% became responders again after treatment, against none on sham (Kitrey et al., J Urol 2016). Results vary between men, and we will advise at consultation whether focused shockwave therapy is suitable for you.

Guidelines and regulation

Our devices are CE-marked medical devices manufactured by Storz Medical, treatment is delivered by HCPC- and NMC-registered clinicians, and our clinic is registered with the Care Quality Commission. The European Association of Urology lists low-intensity shockwave therapy as a treatment option for men with mild vasculogenic ED, for men who respond poorly to PDE5 inhibitor tablets, and for men who do not want or cannot take them (EAU Guidelines 2025). The American Urological Association considers it investigational and advises that further research is continuing (AUA Guideline 2018).

Independent research

The research on focused shockwave therapy for ED has been published in peer-reviewed journals, including the Journal of Urology, the Journal of Sexual Medicine and the Cochrane Database of Systematic Reviews, by independent hospital and university teams in Israel, Greece, Denmark, Turkey, Australia, the United States and Colombia. Trials using the Storz Duolith we use include Olsen et al. (Scand J Urol 2015), in which 57% of treated men achieved intercourse without medication against 9% on sham; Chung et al. (World J Mens Health 2022), in which 70% of treated men gained five points or more against 10% on sham; and Kennady et al. (Sex Med 2023), a trial with no industry funding. The Duolith is the most-studied focused device in erectile dysfunction.

How focused shockwave therapy compares

Unlike tablets, which act on the symptom when taken, focused shockwave aims to improve the health of the blood vessels in the penis. The two can be used together: shockwave combined with daily tadalafil gave additional gains over tadalafil alone (Mykoniatis et al., J Sex Med 2022), and in diabetic men who had not responded to tablets, shockwave combined with a vacuum device produced a meaningful improvement in two-thirds of men (Tao et al., Front Endocrinol 2022). Where a penile implant would suit you better, we will tell you and refer you to a specialist urologist.

How focused shockwave therapy is thought to work

Focused shockwave therapy delivers targeted acoustic waves into the erectile tissue. Laboratory and clinical research suggest these release growth factors and nitric oxide and promote the formation of new small blood vessels, improving blood flow. In the first randomised trial, penile blood flow improved only in treated men (Vardi et al., J Urol 2012), and pooled data show an average rise in peak blood-flow velocity of about 4 cm/s (Sokolakis and Hatzichristodoulou, Int J Impot Res 2019).

Long-term results and our experience

Benefit lasts for most responders for a year or more: in a two-year follow-up, 53% of initial responders still had benefit without further treatment (Kitrey et al., J Urol 2018), and in a five-year series using the Duolith, 40% of all treated men retained a meaningful gain (Chung and Cartmill, Sex Med 2021). Monthly maintenance sessions raised the proportion of men with a meaningful improvement at six months from 36% to 63% (Sandoval-Salinas et al., J Sex Med 2026). We have used focused shockwave therapy since 2013 and record IIEF-5 and Erection Hardness Scores for every patient.

Who is most likely to benefit

Men with mild to moderate vasculogenic ED, men who have stopped responding to tablets, and men who cannot take or prefer not to take tablets show the clearest benefit in the trials. Younger men and men whose ED is of shorter duration respond best (Ortaç et al., Andrology 2021), and trials in men with diabetes have shown good short-term responses (Shendy et al., Andrologia 2021). At MansMatters, men with more severe ED, diabetes or ED after prostate surgery are usually treated within one of our multimodal programmes. Suitability is assessed individually at consultation. It is not suitable for men with the conditions listed under "Is it safe?".

Before your treatment

Before treatment, your clinician will assess the cause and severity of your ED, using the IIEF-5 questionnaire and the Erection Hardness Score, explain what treatment involves, and answer any questions. This information is given verbally at consultation, and you will be asked to give your consent before treatment begins. Courses are six or twelve sessions of 15 to 20 minutes, once or twice a week, with your progress reviewed at the end of the course.

Further clinical trials and reviews

The following peer-reviewed trials and reviews of focused shockwave therapy for erectile dysfunction are also relevant. Each is linked to the original source.