Medical Policies - Surgery
Extracorporeal Shock Wave Therapy in the Treatment of Peyronies Disease
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Extracorporeal shock wave therapy (ESWT) is considered experimental, investigational and/or unproven as a treatment of Peyronie’s disease.
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 for both relief of pain during the acute inflammatory phase, and 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.
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 (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 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 mg/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 (2) 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. The mean disease duration was 16 months. The symptoms were evaluated using a pain symptom score with visual analog pain scale ranging from zero to five. The initial and final erection, as well as a quality of sex-life assessment, was 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 (3,000 shock waves at energy density of 0.3 mJ/mm-2); after one to three 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 (3) 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. Patients received a minimum of three treatment sessions (3,000 shock waves at energy density of 0.3 mJ/mm-2), delivered either at intervals of four weeks or on consecutive days. In addition, patients were evaluated at two months after treatment and were offered up to three 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.
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.
A literature review was conducted through March 2007. No articles were found that would alter the coverage statement. Several additional case series have been published 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.
A search of peer reviewed literature through July 2009 identified no controlled trials were identified. None of the articles identified lead to a change in the coverage statement as the impact of treatment on health outcomes is not known. (4, 5, 6)
A search of peer reviewed literature was conducted through February 2012. In a prospective, randomized, controlled trial, Chitale et al. (10) compared limited ESWT versus sham therapy in men with Peyronie’s disease (PD). In all 36 men were randomized to six sessions of ESWT or sham treatment. Geometrical measurements of penile length and deformity, and the abridged International Index of Erectile Function (IIEF) score and visual analog score (VAS) were recorded and re-evaluated at six months. The patient and assessor were unaware of the treatment type. Standard non-parametric tests were used for the statistical analysis. A full set of outcome data was obtained for 16 patients in the intervention group and 20 in the sham/control group (mean age of 58 and 60 years; mean duration of symptoms of 15 and 33 months). There was no significant difference in the mean change between the control and intervention groups on any outcome measure. There were improvements in the mean (SD.) dorsal and lateral angle, of 5.3 (11.66) degrees and 3.5 (17.38) degrees in the control group, and a deterioration of 0.9 (16.01) degrees and 0.9 (15.56) degrees in the ESWT group. Mean improvements in curved and straight lengths were 0.2 (0.58) and 0.1 (0.8) cm in the control and mean reductions of 0.1 (0.9) and 0.1 (1.49) cm in the ESWT group. The mean changes in the IIEF and VAS scores were 0.1 (3.32) and -0.8 (1.77) for control and 0.56 (2.6) and -1.05 (1.79) for ESWT group. The authors found no significant differences in changes of variables in PD treated with short-term ESWT.
According to a consensus report on the management of Peyronie's disease (9) the following is noted by the authors: “The real etiology of Peyronie's disease and the mechanisms of formation of the plaque still remain obscure. Although conservative management is obtaining a progressively larger consensus among the experts, surgical correction still remains the mainstay treatment for this condition”.
A placebo-controlled prospective study to examine the efficacy of ESWT for men with Peyronie’s disease was reported on by Hatzichristodoulou et.al. in 2013 (11). 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. 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). Authors concluded that 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.
A search of peer reviewed literature through March 14, 2015 identified no additional published studies that would prompt reconsideration of the experimental, investigational and/or unproven coverage statement, which remains unchanged.
UpToDate - Extracorporeal Shock Wave Therapy (12)
This modality remains an investigational treatment due to lack of well-designed trials with long-term follow-up. There are also concerns about the potential side effects including penile fibrosis, secondary PD scarring, and development of erectile dysfunction.
There are limited clinical trial data evaluating the efficacy of ESWT for the treatment of PD. An exploratory meta-analysis of predominantly observational studies determined that ESWT may be somewhat effective in improving penile pain and sexual dysfunction; however, there was insufficient evidence to determine its effect on penile plaque size and curvature. The meta-analysis was limited by several factors, including lack of prospective studies, no blinding in any of the studies, and use of nonstandardized outcome measures.
In a subsequent randomized trial comparing ESWT versus placebo in 100 patients who had not previously received PD-related treatment, there was a statistically significant decrease in mean plaque size (-0.6 versus +1.4 mm2) and curvature (-1.4 versus +1.8 degrees), which is of uncertain clinical significance.
Summary of Evidence
No published studies were identified that would prompt reconsideration of the policy statement, which remains unchanged. Supplemental information was added to support the current coverage position.
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1. Hauck, E.W., Hauptmann, A., et al. Questionable efficacy of extracorporeal shock wave therapy for Peyronie’s disease: results of a prospective approach. Journal of Urology (2004) l71 (1):296-9. PMID: 14665898
2. Lebret, T., Loison, G., et al. Extracorporeal shock wave therapy in the treatment of Peyronie’s disease: experience with standard lithotripter. Urology (2002) 59(5):657-61. PMID: 11992835
3. Manikandan, R, Islam, W., et al. Evaluation of extracorporeal shock wave therapy in Peyronie’s disease. Urology (2002) 60(5):795-800. PMID: 12429298
4. Kiyota, H., Ohishi, Y., et al. Extracorporeal shock wave treatment for Peyronie’s disease using EDAP LT-02: preliminary results. International Journal of Urology (2002) 9(2):110-3. PMID: 12033197
5. Poulkis, V., Skiapas, K., et al. Extracorporeal shockwave therapy for Peyronie’s disease; an alternative treatment? Asian Journal of Andrology (2006 May) 8(3):361-6. PMID: 16625288
6. Srirangam, S. J., Manikandan, R., et al. Long-term results of extracorporeal shockwave therapy for Peyronie’s disease. Journal of Endourology (2006) 20(11):880-4. PMID: 17144855
7. Extracorporeal Shock Wave Therapy in the Treatment of Peyronie’s Disease – Archived: Chicago Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2009 July) Surgery 7.01.110.
8. Palmieri A, Imbimbo C, et al. A first prospective, randomized, double-blind, placebo-controlled clinical trial evaluating extracorporeal shock wave therapy for the treatment of Peyronie's disease. Eur Urol 2009; 56: 363–9. PMID: 19473751
9. Gonzalez-Cadavid, R, Mirone, N, et al. The management of Peyronie's disease: evidence based 2010 guidelines. J Sex Med 2010; 7: 2359–74. PMID: 20497306
10. Chitale S, Morsey M, Swift L, et al. Limited shock wave therapy vs sham treatment in men with Peyronie's disease: Results of a prospective randomized controlled double-blind trial. BJU Int. 2010; 106(9):1352-6. PMID: 20438568
11. Hatzichristodoulou G, Meisner C, et.al. Extracorporeal shock wave therapy in Peyronie's disease: Results of a placebo-controlled, prospective, randomized, single-blind study. J Sex Med 2013; 10:2815–2821. PMID: 23898925
12. Brant, W.O., Bella, A.J., et al. Peyronie's disease: Diagnosis and medical management. In: UpToDate, Post TW (Ed), UpToDate, Waltham, MA. Available at <http://www.uptodate.com> (accessed 2017 July 5).
|6/15/2018||Reviewed. No changes.|
|8/15/2017||Document updated with literature review. Coverage unchanged.|
|7/1/2016||Reviewed. No changes.|
|4/15/2015||Document updated with literature review. Coverage unchanged.|
|4/15/2012||Document updated with literature review. Coverage unchanged.|
|9/1/2009||Revised/updated entire document. Coverage unchanged. Coverage position remains experimental, investigational and unproven.|
|5/15/2007||Revised/updated entire document|
|2/1/2005||New medical document|
|Title:||Effective Date:||End Date:|
|Extracorporeal Shock Wave Therapy in the Treatment of Peyronies Disease||08-15-2017||06-14-2018|
|Extracorporeal Shock Wave Therapy in the Treatment of Peyronies Disease||07-01-2016||08-14-2017|
|Extracorporeal Shock Wave Therapy in the Treatment of Peyronies Disease||04-15-2015||06-30-2016|
|Extracorporeal Shock Wave Therapy in the Treatment of Peyronies Disease||04-15-2012||04-14-2015|
|Extracorporeal Shock Wave Therapy in the Treatment of Peyronies Disease||09-01-2009||04-14-2012|
|Extracorporeal Shock Wave Therapy in the Treatment of Peyronies Disease||05-15-2007||08-31-2009|
|Extracorporeal Shock Wave Therapy in the Treatment of Peyronies Disease||02-01-2005||05-14-2007|