Extracorporeal Shock Wave Therapy in the Treatment of Peyronie's Disease
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 individual 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 individuals the plaque may resolve and disappear entirely. The etiology of Peyronie's is unknown, but is thought to be related to subclinical trauma.
Individuals 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. Non-surgical therapies have included oral antioxidant agents (i.e., 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, in which 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, it has been proposed that ESWT may prompt increased vascularization and a healing response.
POLICY
Extracorporeal shock wave therapy in the treatment of Peyronie's disease is considered investigational.
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ADDITIONAL INFORMATION
The current literature regarding ESWT for Peyronie's disease does not permit scientific conclusions regarding the safety and efficacy of this therapy. Well-designed trials are lacking that provide evidence based data to validate any improvement in health outcomes.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2008). Extracorporeal shock wave therapy in the treatment of Peyronie's disease (2.01.62, ARCHIVED 7/09/2009). Retrieved September 3, 2009 from BlueWeb.
Hauck, E. W., Hauptmann, A., Bschleipfer, T., Schmelz, H. U., Altinklic, B. M., & Weidner, W. (2004). Questionable efficacy of extracorporeal shock wave therapy for Peyronie's disease: Results of a prospective approach. The Journal of Urology, 171 (1), 296-299. (Level 4 Evidence)
Kiyota, H., Ohishi, Y., Asano, K., Hasegawa, N., Madarame, J., Miki, K., et al. (2002). Extracorporeal shock wave treatment for Peyronie's disease using EDAP LT-02; preliminary results. International Journal of Urology, 9 (2), 110-113. (Level 4 Evidence)
Lebret, T., Loison, G., Herve, J-M., McEleny, K. R., Lugagne, P-M., Yonneau, L., et al. (2002). Extracorporeal shock wave therapy in the treatment of Peyronie's disease: Experience with standard lithotriptor (Siemens-multiline). Urology, 59 (5), 657-661. (Level 4 Evidence)
Manikandan, R., Islam, W., Srinivasan, V., & Evans, C. M. (2002). Evaluation of extracorporeal shock wave therapy in Peyronie's disease. Urology, 60 (5), 795-799. (Level 4 Evidence)
National Institute for Health and Clinical Excellence. (2003, December). Extracoporeal shockwave therapy for Peyronie’s disease. Retrieved September 3, 2009 from: http://www.nice.org.uk/nicemedia/pdf/ip/IPG029aguidance.pdf.
Palmieri, A., Imbimbo, C., Longo, N., Fusco, F., Verze, P., Mangiapia, F., et al. (2009). A first prospective, randomized, double-blind, placebo-controlled clinical trial evaluating extracorporeal shock wave therapy for the treatment of Peyronie’s disease. European Urology, 56 (2), 363 - 369. (Level 2 Evidence)
Poulakis, V., Skriapas, k., de Vries, R., DIllenburg,W., Ferakis, N., Witzsch, U., et al. (2006). Extracorporeal shockwave therapy for Peyronie’s disease: an alternative treatment? Asian Journal of Andrology, 8 (3), 361 - 366. (Level 4 Evidence)
ORIGINAL EFFECTIVE DATE: 6/1/2004
MOST RECENT REVIEW DATE: 10/8/2009
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