Traction (RestoreX) 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?

RestoreX is a CE-marked penile traction device designed specifically for Peyronie's disease. It was invented by a Mayo Clinic urologist and developed by PathRight Medical in cooperation with the Mayo Clinic (RestoreX). In a randomised controlled trial of 110 men, only mild and temporary side effects were reported, with no serious adverse events (Ziegelmann et al. 2019). As set out by the manufacturer (RestoreX safety information), it is not suitable for men with severe vascular disease, severe neuropathy, an active urinary or sexually transmitted infection, or a bleeding disorder; men taking blood-thinning medication are assessed individually. Use should be stopped and the clinician consulted if pain, numbness, tingling or skin discolouration occurs. Each patient receives full fitting and one-to-one training in correct use.

What the evidence shows

Penile traction therapy is recommended in European Association of Urology guidelines to reduce curvature in Peyronie's disease, either on its own or as part of a combined approach. In a randomised controlled trial of 110 men at the Mayo Clinic (Ziegelmann et al. 2019), men using RestoreX for 30 to 90 minutes a day for three months improved curvature by an average of 11.7 degrees, compared with a 1.3-degree worsening in untreated men. 77% of treated men saw an improvement, averaging 17.2 degrees, and penile length increased by 1.5 cm compared with no change in the untreated group. Over nine months of follow-up (Joseph et al. 2020), men using the device regularly improved curvature by an average of 14.3 degrees (24%), gained 2.0 to 2.3 cm in length, and reported improved sexual function.

Guidelines and regulation

The European Association of Urology guidelines recommend penile traction therapy to reduce penile deformity in Peyronie's disease, or as part of a multimodal approach. International recommendations (ICSM 2024) also support traction and favour combining treatments. RestoreX is a CE-marked medical device used within its intended purpose for Peyronie's disease (RestoreX). It is fitted and supervised by our clinicians in a clinic registered with the Care Quality Commission.

Independent research

Penile traction therapy for Peyronie's disease has been studied by independent teams in several countries. These include a multicentre controlled study in the stable phase in Spain (Moncada et al. 2019), a controlled study in the active phase, also in Spain (Martínez-Salamanca et al. 2014), and early work in the United States (Levine et al. 2008). These studies used other traction devices and consistently reported improvement in curvature. The RestoreX trials were carried out at the Mayo Clinic (Ziegelmann et al. 2019; Joseph et al. 2020), and the device's inventor was one of the study authors. Traction is supported in European guidelines on the basis of this wider body of evidence.

How traction compares

In a randomised trial, RestoreX improved curvature by an average of 11.7 degrees over three months, with penile length gains of 1.5 cm (Ziegelmann et al. 2019). For comparison, published studies of vacuum therapy report average curvature improvements of between 6.6 degrees (Mortensen et al. 2021) and 23 degrees (Wang et al. 2025). Among non-surgical treatments, traction is notable for randomised evidence of length preservation and gain, which is clinically relevant because Peyronie's disease often causes loss of length. In line with international recommendations favouring combined treatment (ICSM 2024), traction is used alongside other treatments, including within our PD360 programme. Men with severe or complex deformity may be referred to a specialist urologist for surgical assessment.

How traction is thought to work

Penile traction applies a sustained, controlled stretching force to the penis. This is thought to work through mechanotransduction, in which mechanical tension is converted into cellular signals that stimulate tissue remodelling. The aim is to gradually lengthen and realign the affected tunica albuginea, counteracting the contracture caused by the Peyronie's plaque (Sultana et al. 2022). RestoreX is designed to apply traction together with counter-bending, which is intended to target the curvature directly while also preserving length (Ziegelmann et al. 2019).

Long-term results and our experience

The RestoreX trials followed men for up to nine months and found that improvements in curvature and length were maintained, with further gains in men who continued regular use (Joseph et al. 2020). RestoreX has been part of our clinical practice since 2021. It also forms part of our PD360 programme, in which patients are being followed up at 12 months so that longer-term outcomes can be reported.

Who is most likely to benefit

Penile traction therapy has been shown to be effective in both the active phase (Martínez-Salamanca et al. 2014) and the stable phase (Moncada et al. 2019) of Peyronie's disease. It is particularly relevant for men with curvature and associated loss of penile length. Outcomes depend on regular daily use, and greater improvement is seen with consistent use (Joseph et al. 2020). Suitability is assessed individually at consultation, taking into account the phase and severity of the condition and erectile function. Traction 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 traction therapy involves and the current evidence, 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 RestoreX. Daily use of around 30 to 60 minutes is recommended; the manufacturer advises that there is no additional benefit beyond one hour a day (RestoreX). Your progress is reviewed at follow-up appointments.