CAM 20162

Extracorporeal Shock Wave Therapy in the Treatment of Peyronie's Disease

Category:Medicine   Last Reviewed:September 2019
Department(s):Medical Affairs   Next Review:September 2999
Original Date:October 2003    

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 (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, 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.

Policy:
Extracorporeal shock wave therapy (ESWT) is considered INVESTIGATIONAL as a treatment of Peyronie’s disease.

Policy Guidelines 
There is no specific CPT code for ESWT of the penis. It is possible that providers might use CPT code 54360 (plastic operation on penis to correct angulation) to describe ESWT, although it is questionable whether ESWT would constitute an operation. CPT code 55899 (unlisted procedure, male genital system) would be the most appropriate code for this procedure.

Rationale
Evaluation of extracorporeal shock wave therapy (ESWT) for Peyronie’s disease can be assessed in 2 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. (1) 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 photographs 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. (2) 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. (3) 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.

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. 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.
  2. Hauck EW, Hauptmann A, Bschleipfer T et al. Questionable efficacy of extracorporeal shock wave therapy for Peyronie's disease: results of a prospective approach. J Urol 2004; 17(1):296-9.
  3. Manikandan R, Islam W, Srinivasan V et a. Evaluation of extracorporeal shock wave therapy in Peyronie's disease. Urology 2002; 60(5):795-800.
  4. Srirangam SJ, Manikandan R, Hussain J et al. Long-term results of extracorporeal shock wave therapy for Peyronie's disease. J Endourol 2006; 20(11):880-4.

Coding Section

Codes Number Description
CPT 55899

Unlisted procedure, male genital system

ICD-9 Diagnosis  607.85 

 Peyronies's Disease

  607.89

Other specified disorders of the penis

ICD-10-CM (effective 10/01/15)  N485  Ulcer of penis 
  N486  Induration penis plastica 
  N4882 Acquired torsion of penis
  N4889 Other specified disorders of penis

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology© American Medical Association.  All Rights Reserved" 

History From 2014 Forward     

09/04/2019 

Annual review, no change to policy intent. 

09/10/2018 

Annual review, no change to policy intent. 

09/21/2017 

Annual review, no change to policy intent. 

09/19/2016

Annual review, no change to policy intent. 

09/15/2015 

Annual review, no change to policy intent. Added guidelines and coding.

09/07/2014

Annual review, no change to policy.


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