Evaluation of extracorporeal shock wave therapy (ESWT) for Peyronie’s disease can be assessed in two different clinical situations; i.e., in the early acute phase, in which pain relief and interruption of the natural progression to fibrotic disease are relevant outcomes, and during the chronic phase of the disease, in which elimination of curvature of the penis and restoration of normal sexual function are relevant outcomes. In the acute stage, controlled clinical trials are particularly important due to the self-limiting nature of the pain in a percentage of the patients, and also to the well-known placebo response of therapies that have pain relief as the principal outcome. Controlled trials are also important during the chronic phase, since penile curvature may also improve spontaneously. In addition, since normal sexual function is obviously related to a large number of factors, a controlled trial is important to isolate any contribution of ESWT.

 

The literature regarding ESWT for Peyronie’s is characterized by small case series of patients treated in different stages of disease using different protocols with only short-term follow-up. The overall poor quality of the literature does not permit scientific conclusions regarding the safety and efficacy of this therapy. The largest case series of 114 men was reported on by Hauck and colleagues. (Hauck et al, 2004) Men with acute and chronic disease with and without calcified plaques were included; a total of 96 men were available for follow-up. The degree of curvature was documented before and after treatment using photographic pictures taken during full erection. Patients were asked to assess pain and to rate the quality of tumescence and rigidity during erection. Patients underwent an initial session of ESWT (4,000 shock waves at an energy density of 0.17 mJ/mm-2), followed by additional sessions if partial response was noted. Results did not show any significant effect on plaque size and no significant effect on penile curvature. However, there was significant improvement in curvature among a subset of 48 patients with an initial curvature of 31 to 60 degrees. A total of 37 patients reported initial penile pain; 76% of these patients reported improvement in pain. There was no significant improvement in sexual function, penile tumescence, or rigidity. The authors conclude that the efficacy of ESWT for Peyronie’s disease is highly questionable and that a controlled single-blind multicenter study is required.

 

Smaller case series have reported mixed results. For example, Lebret and colleagues reported on a case series of 54 patients with Peyronie’s disease who either had pain on erection or a greater than 20-degree angulation of the penis, or both. (Lebret et al, 2002) The mean disease duration was 16 months. The symptoms were evaluated using a pain symptom score with visual analogue pain scale ranging from 0 to 5. The initial and final erection, as well as a quality of sex-life assessment, were assessed using the International Index of Erectile Function. Curvature was documented by auto-photography before and after treatment, and the penile angle was measured from the photographs. Each patient received a minimum of 1 session of ESWT (3,000 shock waves at energy density of 0.3 mJ/mm-2); after 1 to 3 months of follow-up, patients could elect to receive an additional session if the curvature remained greater than 20 degrees. The mean number of sessions per patient was 1.6. The deviation angle decreased by more than 10 degrees in 53.7% of patients. Among 24 patients with erectile dysfunction, only 6 (25%) had a marked increase in erection quality.

 

Manikandan and colleagues reported on a case series of 42 patients with Peyronie’s disease with a mean duration of disease of 16 months. Patients predominantly presented with angulation of the penis and sexual dysfunction; penile angulation was initially visually and photographically evaluated in the office using injections of alprostadil to induce erection. (Manikandan et al, 2002) Patients received a minimum of 3 treatment sessions (3,000 shock waves at energy density of 0.3 mJ/mm-2), delivered either at intervals of 4 weeks or on consecutive days. In addition, patients were evaluated at 2 months after treatment and were offered up to 3 additional treatment sessions if improvement was not satisfactory. After treatment, penile angulation was evaluated by autophotography. Patients were questioned about pain relief, but the study did not provide details on how this outcome was assessed. A total of 64% of patients reported that they had either excellent or significant improvement in penile angulation, while 36% said they had minimal or no improvement. Of the 25 who had pain on erection before treatment, 84% reported complete or near complete relief after treatment.

 

Several additional case series have been published that report varying response to ESWT. However, as noted by Srirnagam et al in their report, controlled studies are needed to determine the efficacy of this procedure and also to identify the subset of patients who may benefit.  

 

In summary, due to the lack of controlled trials, the available published literature is insufficient to permit scientific conclusions regarding the safety and efficacy of ESWT as a treatment of Peyronie’s disease.  In addition, the impact of treatment on health outcomes is not known.

 

 

  

 

 

 

 

 

 

A literature search conducted using the MEDLINE database through September 2017 did not reveal any new information that would prompt a change in the coverage statement.