PD360 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?

PD360 combines treatments that each have an established safety record. Published studies of Focused Shockwave Therapy (fSWT) report no serious complications (Gul & Serefoglu 2020), PRP injections caused no complications in a placebo-controlled trial (Ledesma et al. 2024), non-cross-linked hyaluronic acid injections and verapamil delivered by EMDA are described as safe in Peyronie’s disease (Milenkovic & Albersen 2020; Sokolakis & Hatzichristodoulou 2020), and traction therapy causes only mild, temporary discomfort (Nicolai & Beck 2020). In our own study of 20 men, currently under peer review, there were no serious side effects; 20% had minor bruising and 15% had short-lived discomfort. PD360 isn’t suitable if you take nitrates, or have uncontrolled heart disease, a bleeding or platelet disorder, or an infection in the area. Injections are given by our registered clinicians and medicines are prescribed by our independent prescribers (meet the team).

What the evidence shows

International recommendations favour combining treatments over using a single treatment for Peyronie’s disease (ICSM 2024). Within PD360, traction therapy has reduced curvature in a randomised trial (Ziegelmann et al. 2019), shockwave helps relieve pain (ICSM 2024), and non-cross-linked hyaluronic acid is recognised as an option in the active phase (EAU guidelines), while the evidence for PRP used on its own is still developing (ICSM 2024). In our own study of 20 consecutive men who had not been treated before, curvature reduced by an average of 50% (from 53 to 27 degrees), erectile function scores improved by around 10 points, and pain resolved in all 12 men who had it. The study had no comparison group and measured results one month after completing the four-month programme; it was awarded first place at [conference name, year] and is currently under peer review.

Guidelines and regulation

PD360 follows the international recommendation to combine treatments for Peyronie’s disease (ICSM 2024). Its components are recognised in international and European guidance for different purposes: traction devices to reduce curvature, shockwave for pain, verapamil to reduce curvature, plaque size or pain in some men, daily tadalafil for associated erectile dysfunction (ICSM 2024), and non-cross-linked hyaluronic acid in the active phase (EAU guidelines). The devices we use are CE-marked, our medicines are UK-licensed and prescribed by our independent prescribers, some used outside their licensed indication as is common in Peyronie’s care, and our clinic is registered with the Care Quality Commission. PRP is not yet routinely recommended in guidelines, which is why we explain each component at consultation and are publishing our own results.

Independent research

Each component of PD360 has been studied by independent university teams, including traction at the Mayo Clinic (Ziegelmann et al. 2019), PRP at the University of Miami (Ledesma et al. 2024), and verapamil and non-cross-linked hyaluronic acid by European urology groups (Milenkovic & Albersen 2020), and the evidence has been reviewed by an international expert panel (ICSM 2024). Our own study of PD360 as a whole was carried out at our clinic with input from a researcher at King’s College London. Mr Almashan’s PD360 research, which is currently undergoing peer review, was awarded 1st Best Oral Abstract Presentation at the Interdisciplinary Urology Care Consortium (IUCC) 2026 in Dubai (6–7 June 2026) for “PD360: A Multimodal Regenerative Protocol Showing Clinically Significant Improvements in Peyronie’s Disease and Associated Erectile Dysfunction.”

How PD360 compares

In our study, curvature reduced by an average of 26 degrees (50%). For context, randomised trials of single treatments report an average improvement of 11.7 degrees with traction therapy (17.2 degrees among men who improved) (Ziegelmann et al. 2019) and around 17 degrees with collagenase injections, which are no longer available in the UK (Gelbard et al. 2013). These figures support combining treatments, which international recommendations favour (ICSM 2024).

How PD360 is thought to work

Each part of PD360 targets a different aspect of Peyronie’s disease. Focussed Shockwave is thought to improve blood flow and ease pain (Li et al. 2024); PRP delivers the body’s own growth factors to support tissue repair (Asmundo et al. 2024); non-cross-linked hyaluronic acid and verapamil are thought to reduce inflammation and slow the scarring process within the plaque (Milenkovic & Albersen 2020); daily tadalafil supports erections and may help reduce scarring (Pozzi et al. 2020); and traction gently stretches and remodels the plaque while helping to maintain length (Nicolai & Beck 2020). Combining them is intended to address the condition from several angles at once.

Long-term results and our experience

Some components of PD360 have shown lasting benefits in long-term studies: pain relief from focussed shockwave has been maintained for three to ten years (Sokolakis et al. 2022; Spirito et al. 2024), and men who continued traction therapy kept improving their length over nine months (Joseph et al. 2020). Our own study measured results one month after completing the four-month treatment programme, and we are following up the men in our study at 12 months so that we can report longer-term outcomes. We have offered PD360 since early 2025.

Who is most likely to benefit

In our study, men aged 33 to 65 with curvature of 40 to 70 degrees improved in both the active and stable phases, with 19 of the 20 men seeing a reduction in curvature. The one man who did not had an unusual, diffuse type of plaque, so we assess the plaque carefully at consultation. PD360 isn’t suitable for men who cannot take daily tadalafil or have uncontrolled heart disease, and where surgery would suit you better, we will tell you and refer you to a specialist urologist.

Before your treatment

PD360 is delivered over four monthly sessions, followed by a review one month after your final session. Your daily tadalafil is prescribed by one of our independent prescribers, and you will receive full fitting and training for your RestoreX traction device. Before you start, your clinician will talk you through each part of the programme, what results to expect and how to use your home treatments safely.