Medicine Section - Extracorporeal Shock Wave Therapy in the Treatment of Peyronie’s Disease

IMPORTANT REMINDER

This Medical Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status.

Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control.

The purpose of medical policy is to provide a guide to coverage. Medical Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care.

Description

Peyronie’s disease is an acquired inflammatory disease of the tunica albuginea and adjacent erectile tissue of the penis, most commonly affecting men between the ages of 45 and 60 years old. In the acute inflammatory stage, the patient may experience pain during flaccidity and/or during erection or sexual intercourse. The pain usually resolves over several months as the acute inflammation subsides, and the condition evolves to a progressive fibrosis with development of a palpable plaque. The plaque may result in curvature of the penis, erectile dysfunction, or distal flaccidity. In some patients the plaque may resolve and disappear entirely. The etiology of Peyronie’s is unknown, but is thought to be related to subclinical trauma.

Patients may seek treatment both for relief of pain during the acute inflammatory phase, and the sexual dysfunction and distortion characterizing the chronic phase. However, conservative treatment options are limited and there is currently no standard nonsurgical therapy. Nonsurgical therapies have included oral antioxidant agents (e.g., vitamin E, potassium aminobenzoate) or intralesional injections of corticosteroids, collagenase, or verapamil. Surgical treatment focuses on excision of the plaque; the "Nesbit" procedure involves excision of the plaque accompanied by patch grafting of the defect left by the excision.

Recently, there has been interest in extracorporeal shock wave therapy (ESWT) as a treatment of Peyronie’s disease. While ESWT is a standard urologic therapy to disintegrate kidney stones, the mechanism of action is unknown in Peyronie’s disease, where the plaques may or may not be calcified. Similar to its proposed mechanisms of action in other soft tissue conditions, such as plantar fasciitis or lateral epicondylitis (tennis elbow), it has been proposed that ESWT may prompt increased vascularization and a healing response when used in the treatment of Peyronie's disease.

Note: ESWT for plantar fasciitis and other musculoskeletal conditions is addressed in a separate policy, Medicine No. 90.

Policy/Criteria

Extracorporeal shock wave therapy is considered investigational as a treatment of Peyronie’s disease.

Scientific Background

Evaluation of extracorporeal shock wave therapy for Peyronie’s disease can be assessed in two different clinical situations, each with different relevant health outcomes:

• The early acute phase where pain relief and interruption of the natural progression to fibrotic disease are relevant
• 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 due to the well known placebo response of therapies whose principal outcome is pain relief. 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 the contribution of ESWT to improved outcomes.

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 largest case series of 114 men was reported on by Hauck and colleagues. (2) 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 0.17mJ/mm-2), followed by initial sessions if partial response was noted. Results did not show any significant effect on plaque size or penile curvature. However, there was significant improvement in curvature among the 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 concluded 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. (3) The mean disease duration was 16 months. The symptoms were evaluated using a pain symptom score with visual analog 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 one session of ESWT (3000 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. (4) 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. Patients received a minimum of 3 treatment sessions (3000 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 auto-photography. 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 other small, uncontrolled case series have been published, which generally report encouraging results, but the lack of controlled trials, consistent treatment protocols, and consistent outcomes limit any scientific interpretation. (5,6)

An updated search of the MEDLINE database through February, 2008, found several additional case series that report varying response to ESWT. However, as noted by the authors in one of these reports, controlled studies are needed to determine the efficacy of this procedure and also to identify the subset of patients who may benefit from it. (7)  None of the articles identified lead to a change in the policy statement. No controlled trials were identified through this review. The use of ESWT in the treatment of Peyronie’s disease is considered investigational because the impact of treatment on health outcomes is not known.

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.

References

1. BlueCross BlueShield Association Medical Policy Reference Manual, Policy No. 2.01.62
2. Hauck EW, Hauptmann A, Bschleipfer T et al. Questionale efficacy of extracorporeal shock wave therapy for Peyronie’s disease: results of a prospective approach. J Urol 2004;17:296-99
3. Lebret T, Loison G, Herve JM et al. Extracorporeal shock wave therapy in the treatment of Peyronie’s disease: experience with standard lithotripter. Urology 2002;59(5):657-61
4. Manikandan R, Islam W, Srinivasan V et al. Evaluation of extracorporeal shock wave therapy in Peyronie’s disease. Urology 2002;60(5):795-800
5. Husain J, Lynn NN, Jones DK et al. Extracorporeal shock wave therapy in the treatment of Peyronie’s disease: initial experience. BJU Int 2000;86(4):466-
6. Kiyota H, Ohishi Y, Asano K et al. Extracorporeal shock wave treatment for Peyronie’s disease using EDAP LT-02: preliminary results. Int J Urol 2002;9(2):110-3
7. Srirangam SJ, Manikandan R, Hussain J et al. Long-term results of extracorporeal shockwave therapy for Peyronie's disease. J Endourol. 2006;20(11):880-4

Cross References

Extracorporeal Shock Wave Treatment for Plantar Fasciitis and Other Musculoskeletal Conditions, Regence Medical Policy Manual, Medicine, Policy No. 90

Medicine Section Table of Contents