Multimodal Programme 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?
The Multimodal Programme combines focused shockwave therapy, EMTT and NanoVi Exo in each session. Each component has its own safety profile, set out on its own page. In brief, focused shockwave showed no difference in side effects from sham treatment across 20 randomised trials (Ergun et al., Cochrane 2025); EMTT’s controlled trials report only temporary skin redness and discomfort during treatment (Hollander et al. 2026); and NanoVi Exo delivers humidified room air with no reported adverse events. Men with pacemakers or implanted electronic devices cannot have EMTT, and men on anticoagulants or with bleeding disorders are assessed individually before shockwave. EMTT is used for erectile dysfunction outside its listed indications, and we say so in consent. We monitor every patient throughout the programme.
What the evidence shows
Combining treatments gives greater improvement than single treatments. Across 32 randomised trials, adding a second treatment to tablets improved erectile function scores, with the largest gains, around 4 to 5 points, in men who had not responded to one treatment alone or who were recovering from prostate surgery (Mykoniatis et al., JAMA Netw Open 2021). Shockwave combined with daily tadalafil gave consistent additional gains (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, roughly double either treatment alone (Tao et al., Front Endocrinol 2022). In a randomised trial in rotator cuff tendinopathy, EMTT added to shockwave outperformed shockwave alone (Klüter et al., Electromagn Biol Med 2018). Any outcome figures we quote for the programme are our own service data.
Guidelines and regulation
The European Association of Urology lists low-intensity shockwave, with or without a PDE5 inhibitor, as a treatment option for mild vasculogenic ED, for men who respond poorly to tablets and for men who cannot take them, and its combination-therapy guidance includes tablets with shockwave or vacuum devices (EAU Guidelines 2026). The International Consultation on Sexual Medicine describes regenerative and combination therapies as promising, with further research continuing (Chubak et al., Sex Med Rev 2026). Treatment is given by HCPC- and NMC-registered clinicians in a clinic registered with the Care Quality Commission.
Independent research
Each component has been studied by independent teams and published in peer-reviewed journals: focused shockwave in Israel, Greece, Denmark, Turkey, Australia and the United States, including the 2025 Cochrane review; combination treatment with tablets in Greece and Brazil (Baccaglini et al., J Sex Med 2020) and Spain (Vinay et al., World J Urol 2021); and EMTT by university teams in Germany (Hollander et al. 2026).
How the Multimodal Programme compares
The programme is built on focused shockwave, the component with the largest trial base, and adds EMTT for blood-vessel growth factors and NanoVi Exo for oxidative stress. The combination literature shows that multimodal approaches help most in men who have not responded to a single treatment. Men with severe erectile dysfunction, significant other conditions or an unclear diagnosis are referred for a urological opinion where appropriate.
How the Multimodal Programme is thought to work
Each component targets a different part of the problem. Focused shockwave releases growth factors and promotes new blood-vessel formation in erectile tissue (Sokolakis and Hatzichristodoulou, Int J Impot Res 2019); EMTT increases VEGF-A secretion and the regenerative activity of cells (Gerdesmeyer et al. 2022); and NanoVi Exo supports the body’s response to oxidative stress, a known contributor to damage of the blood-vessel lining (Zhu et al. 2025).
Long-term results and our experience
Shockwave’s benefit has been maintained for 24 months in a Storz-device trial (Lange et al., Transl Androl Urol 2024). We have delivered focused shockwave for erectile dysfunction since 2013, EMTT for five years and NanoVi Exo for four years, and we record outcomes for every patient.
Who is most likely to benefit
Men with mild to moderate vasculogenic erectile dysfunction; men who have responded poorly to tablets, in whom combination approaches show the largest gains; men with diabetes or cardiovascular disease who want to address the underlying tissue health; and men who prefer a non-drug approach or cannot take tablets. 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 erectile dysfunction, using the IIEF-5 questionnaire, examination and blood tests where appropriate, explain what each part of the programme involves, and answer any questions. You will be asked to give your consent before treatment begins. A course is six or twelve sessions, and your progress is reviewed at the end.
Further clinical trials and reviews
The following peer-reviewed trials and reviews are also relevant. Each is linked to the original source.