Coverage Policy Manual
Policy #: 2009008
Category: Surgery
Initiated: April 2009
Last Review: October 2018
  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 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, 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 (tennis elbow), it has been proposed that ESWT may prompt increased vascularization and a healing response.

Policy/
Coverage:
Extracorporeal Shock Wave Therapy for Peyronie's Disease does not meet Primary Coverage Criteria that there be scientific evidence of effectiveness and is not covered.
 
Extracorporeal Shock Wave Therapy is a specific contract exclusion in most member benefit certificates.
 
For contracts without Primary Coverage Criteria, Extracorporeal Shock Wave Therapy for Peyronie's Disease is considered investigational.  Investigational services are an exclusion in the member certificate of coverage.

Rationale:
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.
 
2011 Update
A literature search was conducted using the MEDLINE database through October 2011. There were no studies identified that would prompt a change in the coverage statement.
 
2013 Update
A literature search was conducted using the MEDLINE database through September 2013.  No new information was identified that would prompt a change in the coverage statement.
  
2014 Update
A literature search conducted through September 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
A randomized, single-blind study was performed by Hatzichristodoulou and colleagues to study the efficacy of ESWT by a placebo-controlled, randomized trial (Hatzichristodoulou, 2013). Patients with PD (n=102) were randomly assigned (n=51) to each group (ESWT or placebo). All patients were given 6 weekly treatments. Patients in the ESWT-group received 2,000 shock waves per session, using the Piezoson 100 lithotripter (Richard Wolf, Knittlingen, Germany). Patients in the placebo-group were treated with interposition of a plastic membrane, which prevented any transmission of shock waves. The main outcome measures of the primary end point were decrease of pain between baseline and after 4 weeks follow-up. Secondary end points were changes in deviation, plaque size, and sexual function. Pain was assessed by a visual analog scale. Deviation was measured by a goniometer after artificial erection using Alprostadil (Viridal®, Schwarz Pharma, Monheim, Germany). Plaque size was measured with a ruler and sexual function assessed by a scale regarding the ability to perform sexual intercourse. Overall, only 45 patients experienced pain at baseline. In the subgroup analysis of these patients, pain decreased in 17/20 (85.0%) patients in the ESWT group and 12/25 (48.0%) patients in the placebo group (P=0.013, relative risk [RR]=0.29, 95% confidence interval: 0.09-0.87). Penile deviation was not reduced by ESWT (P=0.66) but worsened in 20/50 (40%) and 12/49 (24.5%) patients of the ESWT and placebo-group, respectively (P=0.133). Plaque size reduction was not different between the two groups (P=0.33). Additional, plaque size increased in five patients (10.9%) of the ESWT group only. An improvement in sexual function could not be verified (P=0.126, RR=0.46).
 
Despite some potential benefit of ESWT in regard to pain reduction, it should be emphasized that pain usually resolves spontaneously with time. Given this and the fact that deviation may worsen with ESWT, this treatment cannot be recommended.
 
2015 Update
A literature search conducted through September 2015 did not reveal any new information that would prompt a change in the coverage statement.
 
2016 Update
A literature search conducted through September 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Hatzichristodoulou and colleagues published a placebo-controlled randomized trial to study the efficacy of ESWT (Hatzichristodoulou, 2013). Patients with PD (n=102) were randomly assigned (n=51) to each group (ESWT or placebo). All patients were given 6 weekly treatments. Patients in the ESWT-group received 2,000 shock waves per session, using the Piezoson 100 lithotripter (Richard Wolf, Knittlingen, Germany). Patients in the placebo-group were treated with interposition of a plastic membrane, which prevented any transmission of shock waves. Primary end point was decrease of pain between baseline and after 4 weeks follow-up. Secondary end points were changes in deviation, plaque size, and sexual function. Pain was assessed by a visual analog scale. Deviation was measured by a goniometer after artificial erection using Alprostadil (Viridal®, Schwarz Pharma, Monheim, Germany). Plaque size was measured with a ruler and sexual function assessed by a scale regarding the ability to perform sexual intercourse. Overall, only 45 patients experienced pain at baseline. In the subgroup analysis of these patients, pain decreased in 17/20 (85.0%) patients in the ESWT group and 12/25 (48.0%) patients in the placebo group (P=0.013, relative risk [RR]=0.29, 95% confidence interval: 0.09-0.87). Penile deviation was not reduced by ESWT (P=0.66) but worsened in 20/50 (40%) and 12/49 (24.5%) patients of the ESWT and placebo-group, respectively (P=0.133). Plaque size reduction was not different between the two groups (P=0.33). Additional, plaque size increased in five patients (10.9%) of the ESWT group only. An improvement in sexual function could not be verified (P=0.126, RR=0.46).
 
2017 Update
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.
 
2018 Update
A literature search was conducted through September 2018.  There was no new information identified that would prompt a change in the coverage statement.  

CPT/HCPCS:
55899Unlisted procedure, male genital system

References: Hatzichristodoulou G, Meisner C, Gschwend JE et al.(2013) Extracorporeal shock wave therapy in Peyronie's disease: results of a placebo-controlled, prospective, randomized, single-blind study. J Sex Med. 2013 Nov;10(11):2815-21. doi: 10.1111/jsm.12275. Epub 2013 Jul 30.

Hatzichristodoulou G, Meisner C, Gschwend JE, et al.(2013) Extracorporeal shock wave therapy in Peyronie's disease: results of a placebo-controlled, prospective, randomized, single-blind study. J Sex Med. 2013 Nov;10(11):2815-21.

Hauck EW, Hauptmann A, Bschleipfer T et al.(2004) Questionable efficacy of extracorporeal shock wave therapy for Peyronie's disease: results of a prospective approach J Urol 2004;171(1):296-299.

Hellstrom W.(2008) Medical Management of Peyronie's Disease J Androl. 2008 Oct 30. Available at http://www.andrologyjournal.org/cgi/rapidpdf/jandrol.108.006221v1. Accessed April 1, 2009.

Lebret T, Loison G, Herve JM et al.(2002) Extracorporeal shock wave therapy in the treatment of Peyronie's disease: experience with standard lithotripter. Urology 2002; 59(5):657-661.

Manikandan R, Islam W, Srinivasan V et al.(2002) Evaluation of extracorporeal shock wave therapy in Peyronie's disease. Urology 2002; 60(5):795-800.

Srirangam SJ, Manikandan R, Hussain J et al.(2006) Long-term results of extracorporeal shockwave therapy for Peyronie's disease. J Endourol 2006; 20(11):880-884.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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