Multimodal Programme 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?

The Multimodal Programme combines non-invasive treatments that each have an established safety record. Studies of Focused Shockwave Therapy (fSWT) report no serious side effects (Li et al. 2024). Extracorporeal Magnetotransduction Therapy (EMTT) may cause only mild, short-lived skin redness (Hollander et al. 2026), and the NanoVi Exo user manual reports no known side effects. Penile traction causes only mild, temporary discomfort (Ziegelmann et al. 2019), and vacuum therapy is safe when used as trained (Wang et al. 2025). Men taking blood-thinning medication, or with a bleeding or clotting disorder, a pacemaker or other electronic implant, are assessed individually, and the programme is tailored accordingly. Each component's clinical evidence page sets out its full safety information. All treatment is given by our registered clinicians, and each patient receives full fitting and one-to-one training for their vacuum or traction device.

What the evidence shows

International recommendations favour combining treatments over using a single treatment for Peyronie's disease (ICSM 2024). Within the Multimodal Programme, fSWT is recommended for pain in European Association of Urology guidelines, and traction and vacuum devices are recommended to reduce curvature. In a randomised trial combining fSWT with a vacuum device, curvature improved by an average of 12.8 degrees, compared with 6.6 degrees with the vacuum device alone (Mortensen et al. 2021). In a randomised trial of traction, curvature improved by an average of 11.7 degrees and length increased by 1.5 cm (Ziegelmann et al. 2019). A 2026 review found that EMTT gave better results combined with shockwave than shockwave alone (Leyva Martínez et al. 2026). The complete MansMatters Multimodal Programme has not itself been evaluated in a randomised controlled trial. Its clinical rationale is based on evidence for the individual treatments and for certain combinations of those treatments.

Guidelines and regulation

The Multimodal Programme follows the European Association of Urology guidelines, which recommend fSWT for pain and traction or vacuum devices to reduce deformity, including as part of a multimodal approach. International recommendations also favour combining treatments (ICSM 2024). All devices used are CE-marked, and treatment is given by registered clinicians in a clinic registered with the Care Quality Commission.

Independent research

Each component of the Multimodal Programme has been studied by independent teams and published in peer-reviewed journals: fSWT in Italy (Palmieri et al. 2009), Germany (Sokolakis et al. 2022) and Denmark (Mortensen et al. 2021); traction in Spain (Moncada et al. 2019) and the United States (Ziegelmann et al. 2019); vacuum therapy in London (Raheem et al. 2010) and by an international expert panel (Wang et al. 2025); and EMTT by university teams in Germany (Hollander et al. 2026).

How the Multimodal Programme compares

Combining treatments produces greater improvement than single treatments. In a randomised trial, adding fSWT to a vacuum device almost doubled the improvement in curvature, from 6.6 to 12.8 degrees (Mortensen et al. 2021). Traction used on its own improved curvature by an average of 11.7 degrees (Ziegelmann et al. 2019). This is why the programme combines fSWT for pain, a vacuum or traction device for curvature and length, and EMTT and NanoVi Exo to support tissue recovery. Men with severe or complex deformity may be referred to a specialist urologist for surgical assessment.

How the Multimodal Programme is thought to work

Each component targets a different aspect of Peyronie's disease. fSWT is thought to improve blood flow and ease pain (Li et al. 2024). EMTT is thought to stimulate cell activity and tissue remodelling (Mancini et al. 2025). NanoVi Exo supports the body's response to oxidative stress, which plays a part in Peyronie's disease (Paulis et al. 2022; Yablonskaya et al. 2022). Vacuum and traction devices apply controlled stretching, which is thought to stimulate remodelling of the affected tissue and preserve length (Sultana et al. 2022).

Long-term results and our experience

Pain relief from fSWT has been maintained for three to ten years (Sokolakis et al. 2022; Spirito et al. 2024), and improvements with traction have been maintained over nine months of follow-up (Joseph et al. 2020). We have used vacuum therapy since 2019, EMTT for five years and NanoVi Exo for four years, and we record outcomes for every patient.

Who is most likely to benefit

The Multimodal Programme is suitable for men in both the active and stable phases of Peyronie's disease, combining treatment for pain with treatment for curvature and length. Suitability is assessed individually at consultation, taking into account the phase and severity of the condition, plaque characteristics and erectile function. It is not suitable for men with the conditions listed under "Is it safe?". Men with severe or complex deformity may be referred to a specialist urologist for surgical assessment.

Before your treatment

Before treatment, your clinician will assess your suitability, explain what each part of the programme involves, and answer any questions. This information is given verbally at consultation, and you will be asked to give your consent before treatment begins. You will receive a full fitting and one-to-one training in the correct use of your vacuum or traction device.