ED360 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?
ED360 is our monthly non-surgical treatment programme for erectile dysfunction. It combines focused shockwave therapy, EMTT and NanoVi Exo with platelet-rich plasma, prepared from your own blood and photoactivated, and hyaluronic acid, both injected into the erectile tissue. A medical vacuum pump (to be confirmed) and, where clinically appropriate, prescribed medication* (to be confirmed) may also form part of your programme. The safety of each component is set out on its own page: focused shockwave showed no excess side effects across 20 randomised trials (Ergun et al., Cochrane 2025); PRP trials report injection-site pain, occasional bruising and, rarely, a small plaque, with no serious events (Poulios et al., J Sex Med 2021); EMTT’s controlled trials report temporary skin redness; NanoVi Exo delivers humidified room air. We check for the contraindications of every component (implanted electronic devices, anticoagulants and bleeding disorders, active infection, a penile implant) and record and review any adverse event.
*Any prescription-only medication used as part of ED360 is prescribed by one of our NMC-registered prescribers following clinical assessment.
What the evidence shows
ED360 is built on the two components with randomised sham- or placebo-controlled evidence in erectile dysfunction. Focused shockwave produced a significant improvement in erectile function over sham across 21 randomised trials (Ergun et al. 2025), and PRP produced a clinically meaningful improvement in around 70% of men at six months in two placebo-controlled trials (Poulios et al. 2021; Shaher et al., Urology 2023). A prospective series of 400 men found that shockwave combined with PRP gave the largest and most sustained improvement (Dogan and Cil, Arch Esp Urol 2025), and a double-blind trial of the combination is ongoing (NCT05048667). Hyaluronic acid: (evidence to be supplied). Any outcome figures we report for ED360 are our own service data.
Guidelines and regulation
The European Association of Urology lists shockwave as a treatment option in mild vasculogenic erectile dysfunction and in men who respond poorly to tablets (EAU Guidelines 2025/2026). The American Urological Association considers shockwave investigational and PRP experimental and advises that further research is needed (AUA Guideline 2018). The International Consultation on Sexual Medicine describes regenerative therapies as promising, with further research continuing (Chubak et al., Sex Med Rev 2026). Treatment is given by registered clinicians in a clinic registered with the Care Quality Commission. Our PD360 outcome study has been submitted for peer review, and ED360 outcome data are being collected on the same basis (to be confirmed).
Independent research
Focused shockwave has been studied by independent teams in Israel, Greece, Denmark, Turkey, Australia and the United States, and PRP by university teams in Greece and Egypt. Photoactivation has been studied in diabetic erectile dysfunction in the laboratory, where red and near-infrared light restored erectile pressure to about 90% of normal (Anita et al., Sci Rep 2025) and photoactivated PRP has been studied in knee osteoarthritis (Paterson et al., BMC Musculoskelet Disord 2016).
How ED360 compares
Against shockwave alone, ED360 adds PRP and hyaluronic acid injection, EMTT, NanoVi Exo and photoactivation, so that several parts of the erectile mechanism are addressed together. Against tablets, the programme aims at tissue repair rather than symptom relief, and multimodal approaches help most in men who have not responded to a single treatment (Mykoniatis et al., JAMA Netw Open 2021). Where a penile implant would suit you better, we will tell you and refer you for a surgical opinion.
How ED360 is thought to work
Each component targets a different part of the erectile mechanism: shockwave and EMTT the blood vessels and tissue regeneration; PRP the delivery of growth factors; hyaluronic acid (to be supplied); NanoVi Exo the oxidative stress that damages the blood-vessel lining; photoactivation the activation of platelets; the vacuum pump, where used, the regular oxygenation of tissue between sessions; and medication, where prescribed, the biochemistry of the erection itself.
Long-term results and our experience
Shockwave’s benefit has been measured for up to five years, with 40% of men retaining a meaningful gain in one series (Chung and Cartmill, Sex Med 2021), and PRP’s for six months in the randomised trials and two years in an extension study. MansMatters has treated (number to be supplied) men with ED360 since (year to be supplied); we record IIEF-5 and Erection Hardness Scores at baseline and follow-up for every patient.
Who is most likely to benefit
Men with moderate to severe vasculogenic erectile dysfunction who have responded poorly to tablets and want a monthly non-surgical programme, and men with diabetes or cardiovascular disease whose erectile dysfunction has more than one contributing cause. It is not suitable for men with pacemakers or implanted electronic devices, uncontrolled bleeding risk, or a penile implant.
Before your treatment
Your clinician will assess the cause and severity of your erectile dysfunction, check for the contraindications of every component, record a baseline and go through the evidence, expected side effects and costs. You will be asked to give your consent before treatment begins. The programme runs over approximately (number to be supplied) monthly appointments of about an hour, with review at each session.
Further clinical trials and reviews
The following peer-reviewed trials and reviews are also relevant. Each is linked to the original source.