Focused Shockwave Therapy (fSWT) Clinical Evidence

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 (fSWT) devices are made by Storz Medical AG and are CE-marked medical devices; the Duolith SD1 is listed by the manufacturer for use in Peyronie's disease. A 2024 review of 7 controlled studies (475 men) found its clearest benefit is pain relief, with mixed evidence for improving curvature. As set out in the manufacturer's operating manual, it isn't suitable if you have a bleeding or clotting disorder, a blood clot or tumour in the treatment area, or have had steroid treatment in the last 6 weeks; men taking blood-thinning medication are assessed individually. Temporary swelling, bruising or tenderness can occur.

Why we offer Focused Shockwave Therapy (fSWT)

Focused Shockwave Therapy (fSWT) is a non-invasive treatment, given without anaesthetic, and is recognised in European Association of Urology guidelines for relieving penile pain in Peyronie's disease. In a placebo-controlled trial using the Storz Duolith (Palmieri et al., European Urology 2009; 100 men), men receiving Focused Shockwave Therapy (fSWT) reported improvements in pain, erectile function and quality of life at 12 weeks, and a separate sham-controlled trial found pain relief was still present three years later (Sokolakis et al., Int J Impot Res 2022). Evidence on curvature is mixed: a 2024 review of 7 controlled studies (475 men) found more men improved than with placebo, although the average change in angle was small (Li et al., BMC Urology 2024), and in a Duolith SD1 trial combined with a vacuum pump, curvature improved by an average of 12.8° with active Focused Shockwave Therapy (fSWT) against 6.6° with sham treatment, a difference not large enough to be statistically significant (Mortensen et al., Res Rep Urol 2021). In a 20-year follow-up of 85 men treated with higher-energy focused lithotripters, 68% of those who had difficulty with intercourse reported improvement (Rassweiler et al., World J Urol 2024). No serious side effects were reported in these studies. Results vary between men, and we will advise at consultation whether Focused Shockwave Therapy (fSWT) is suitable for you.

How Focused Shockwave Therapy (fSWT) is thought to work

Focused Shockwave Therapy (fSWT) delivers targeted acoustic waves to the plaque. Laboratory and clinical research suggests these may reduce inflammation, lower the signals that drive scar tissue formation, improve blood flow, and calm the nerves causing pain (Li et al., BMC Urology 2024; Mortensen et al., Res Rep Urol 2021).

Guidelines and regulation

Our Focused Shockwave Therapy (fSWT) devices are CE-marked medical devices manufactured by Storz Medical, and our clinic is registered with the Care Quality Commission. The European Association of Urology recommends shockwave therapy, such as Focused Shockwave Therapy (fSWT), for penile pain in the active phase of Peyronie's disease; for curvature, it recommends vacuum and traction devices, which is why we use Focused Shockwave Therapy (fSWT) as part of a combined programme rather than on its own. The UK's National Institute for Health and Care Excellence (NICE) considers the safety of shockwave therapy for Peyronie's disease adequate, but asks providers to give clear information about the uncertainty in its effectiveness and to audit their results. We follow these arrangements: every patient is fully informed and gives consent, and we record outcomes for every course of Focused Shockwave Therapy (fSWT).

Independent research

The research on Focused Shockwave Therapy (fSWT) for Peyronie's disease has been published in peer-reviewed medical journals, including European Urology, BMC Urology and the International Journal of Impotence Research, by independent hospital and university teams in Italy, Germany, Denmark and the UK. These teams used several different makes of device, including the Storz Duolith we use. Pain relief has been found consistently across these groups, which is why it is the benefit recognised in European guidelines. Results for curvature have been less consistent between studies, and we explain this openly at consultation.

How Focused Shockwave Therapy (fSWT) compares

For pain, Focused Shockwave Therapy (fSWT) reduced pain scores by an average of 2.5 points (on a 0–10 scale) more than sham treatment, lasting three years (Sokolakis 2022), and is a non-drug option alongside anti-inflammatory medicines. For curvature, traction devices have stronger evidence, at around 15° improvement (EAU guidelines), so we combine Focused Shockwave Therapy (fSWT) with vacuum or traction devices. Where surgery would suit you better, we will tell you and refer you to a specialist urologist.

Long-term results

Studies following men for three to ten years after Focused Shockwave Therapy (fSWT) for Peyronie's disease show that pain relief lasts: the benefit was maintained at three years in a sham-controlled trial, with no treatment-related complications (Sokolakis 2022), and in a 10-year study of 194 men, 90% remained satisfied and only 4% later needed surgery (Spirito 2024). Erectile function is treated with a different Focused Shockwave Therapy (fSWT) protocol, applied along the length of the penis. A 2025 Cochrane review of 21 trials (1,357 men) found that men treated with Focused Shockwave Therapy (fSWT) had better erectile function scores than those given sham treatment, with the benefit growing to more than 5 points over the longer term. The reviewers called for further high-quality trials to confirm these results (Cochrane review).

Who is most likely to benefit

Most research on Focused Shockwave Therapy (fSWT) has involved men in their 50s and 60s, mainly in Europe, and no studies have yet reported results by ethnicity. Studies suggest younger men (Taylor 2006; Abdessater 2022) and men treated in the active, painful phase respond best, while men with diabetes may get less pain relief (di Mauro 2019). Results by severity of curvature and plaque calcification vary between studies (Rassweiler 2024; Mortensen 2021). We take these factors into account at consultation and tell you honestly how likely you are to benefit.