***Trost Commentary and Key Take-Home Points***
Shockwave therapy is a very hot topic in sexual medicine and is very commonly advertised for Peyronie’s Disease and erectile dysfunction. However, as of August, 2020, shockwave therapy is not ready for primetime and should not be recommended or used in Peyronie’s Disease. Although a full description of data behind that comment is beyond the scope of this commentary, here are some brief reasons why I would not recommend shockwave for PD at this point:
- The far majority of data on its treatment relates to a different form of shockwave therapy than is used by “Men’s Health” clinics. Most of those clinics use low-intensity shock wave, or pulse waves (Gainswave). Pulse waves have no randomized (high quality) data showing any benefit in Peyronie’s. Low-intensity similarly does not have sufficient data to suggest any real benefits.
- The available data on high-intensity shockwave therapy is conflicting.
- Both the data, and my experience in seeing PD men, would suggest that shockwave therapy is just as likely (or more) to worsen PD than to help it. I’ve seen many examples of otherwise stable disease be reactivated and worsen following shockwave therapy.
- The AUA does not recommend shockwave therapy to treat penile curvature.
- The Sexual Medicine Society of North America (SMSNA) has a position statement against the use of shockwave therapy outside of a clinical trial.
- I see many patients who are upset and feel that they were ‘swindled’ by various Men’s Health Clinics that treated them with shockwave therapy. Some of these clinics require the men to sign treatment contracts, among other unethical practices.
Peyronie’s disease is a condition characterized by fibrotic plaques in the penis which can cause painful erections, curvature and sexual dysfunction. It affects between 0.5-20% of the population and is most common white males in their 50s. It is thought to be caused by repeated microtraumas resulting in plaque formation. It is categorized as either active/acute stage (including pain and changing symptoms) or stable/chronic stage, where symptoms remain unchanged longer than 3 months.
There are many therapies and treatments, both conservative and invasive, aimed at curvature correction. Surgery is the gold standard treatment for patients in the chronic stage, and consist of Nesbit wedge resection, plication and tunical lengthening. Intralesional injections of collagenase clostridium histolyticum has been used to treat curvature, though it has little effect on pain or erectile dysfunction. Additionally, it has several adverse side effects, as does intralesional interferon alpha-2b. Topical treatments include verapamil gel, iontophoresis and extracorporeal low-intensity shockwave therapy (ESWT), though evidence for verapamil and iontophoresis is inconclusive. However, there is evidence for the treatment of pain using ESWT.
A review of the literature was performed on 25 studies on the use of shockwave therapy in the treatment of Peyronie’s disease.
Shockwave therapy uses acoustic wave energy to transmit pressure to a specific location and use mechanical force to enact biologic change on tissue. High and low intensity shockwave therapies have been used in the orthopedic setting and in managing chronic wounds, peripheral neuropathy and cardiac ischemic tissue. ESWT causes stress from wave-induced mechanical trauma which results in angiogenic growth factors and stimulates neovascularization.
In Peyronie’s disease, there are 2 hypotheses about how ESWT works. The first is that shockwaves damage the plaques and the second is that the shockwaves simulate an inflammatory reaction leading to plaque lysis.
ESWT was first used to treat Peyronie’s disease in 1999 by Abdel-Salam et al, who treated 24 men, 17% of whom showed improvement in all signs and symptoms and 42% reported painless erections and lessened curvature.
The 4 primary outcomes for successful Peyronie’s disease treatment include penile curvature, plaque size, erectile dysfunction and penile pain and the efficacy varies widely throughout the literature.
-Penile Curvature: Palmieri et al examined 88 patients who received ESWT weekly for 4 weeks. At 2 years follow-up, mean curvature decreased by 1.41 degrees. Hatzichristodoulu et al evaluated 102 men with Peyronie’s disease and showed that 32% saw reduced penile deviation, but 40% saw worsened deviation, leading to a recommendation against ESWT as authors attributed this worsening as possible tissue damage from the shockwave therapy. Hauck et al followed 96 patients and saw a 5.8 degree decrease in penile curvature, though results were not statistically significant.
-Plaque Size: All studies used Doppler ultrasound and ruler measurements to assess plaque size. None of the randomized controlled trials showed significant reduction in plaque size, only a meta-analysis of 3 studies by Gao et al showed a significant decrease (39%) in plaque size.
-Erectile Dysfunction: Most studies used the International Index of Erectile Dysfunction (IIEF-5) questionnaire to assess sexual function. Two of the three randomized controlled trials and many of the non-randomized controlled trials showed statistically significant improvement in IIEF-5 score, though recent meta-analyses evaluated IIEF-5 scores in 296 patients and saw no statistically significant improvement. Thus, it remains inconclusive.
-Pain: Pain was assessed by all using the visual analog scale (VAS) where a patient’s pain is scored from 0-10 (0 is no pain, 10 is strong pain). No studies showed statistically significant changes in VAS scores, but most did see significant differences between the therapy arm and the control arm of the study. Pain also can self-resolve over time in 89% of men, so it is difficult, if not impossible, to distinguish between the effects of ESWT or time.
Both the American Urological Association (AUA) and the European Association of Urology (EAU) guidelines allow shockwave therapy to be offered as an alternate pain control when other methods have failed. It is not recommended for the correction of curvature or reduction of plaque size. It instead recommends intralesional collagenase clostridium histolyticum injections for qualifying patients.
The risks of using ESWT to treat Peyronie’s disease is low and most adverse events are minor, including local pain, skin hematoma and local petechiae, which all resolved on their own. Only 1 study reported worsening of curvature, but was unique in that respect.
The European Society for Sexual Medicine surveyed 192 physicians and while 75% of them were familiar with ESWT as a treatment option for sexual medicine, only 14.1% had used it in their practice. Though 71.5% considered it an effective treatment for erectile dysfunction and only 6.9% thought it effective for Peyronie’s disease.
Taylor et al did a study on 36 men to compare patient characteristics with successful outcomes with ESWT. He concluded that younger men with milder disease had better outcomes than older men with more severe disease. This could be due to angiogenesis being easier in younger patients.
Shockwave therapy may have some role for refractory penile pain or plaque size, however, its true efficacy is controversial in every aspect of Peyronie’s disease including penile curvature, plaque size, erectile dysfunction and penile pain. Neither the AUA nor the EAU recommend the use of shockwave therapy in the treatment of Peyronie’s disease. A multi-institutional trial with strict inclusion criteria and standardized methods is needed to determine the true efficacy of shockwave therapy in Peyronie’s Disease.
Krieger JR, Rizk PJ, Kohn TP, et al. Shockwave Therapy in the Treatment of Peyronie’s Disease. Sex Med Rev 2019;7:499–507.