Peyronie’s disease

Peyronie’s disease, commonly referred to as curvature of the penis, is a benign condition. It begins when a dense plaque forms in the outer layers of the penis. The plaque prevents an even expansion during an erection causing a variety of penile deformities during the erect state including curvature, shortening and narrowing.

Peyronie’s disease was initially described by the French surgeon, François Gigot de Lapeyronie, in 1743 even though there are vague references to the disease going back all the way to 1561 and even in sculpture dating back to 3000 BC. Peyronie’s is not a new disease.3-4

Men most often identify Peyronie’s with penile curvature, indentation or other deformities. Deformities associated with Peyronie’s disease may be severe enough to prevent intercourse or, at a minimum, may reduce overall satisfaction. Other symptoms may include inflammation, a lump in the shaft of the penis, pain and erectile dysfunction. As a result, PD can be both physically and psychologically difficult for men and may negatively impact their relationship.5-12

Although PD has been recognized and studied for more than 250 years, many misconceptions remain. Common misconceptions include the belief that PD is uncommon, only affects older men, is not associated with ED, lacks treatment options, and resolves over time. None of these statements are true!

Another common and widespread misconception is that men should wait to treat PD until it is at least 6 – 12 months after the disease has progressed. While this is true for men undergoing surgery, the opposite is true for conservative, less invasive treatments such as traction therapy. A study by Martinez–Salamanca and colleagues clearly demonstrated the benefits with using traction therapy early on in the disease process.13-14

The true prevalence of PD is not known.  Depending on the definition of the disease, age, and methods to diagnose, the condition is estimated to affect anywhere from 0.4% to 13% of men. PD is more common in Caucasian men of Northern European origin but can affect men of any heritage. PD may be more common following prostatectomy (16%) or in diabetic men with ED (20%).15-22

Some men are not aware that they have the disease and it is estimated that 15-58% of men may be unaware of the condition.

In 2015, an International Consensus Panel on Sexual Medicine (ICSM) met to discuss the role of penile traction therapy in treating various conditions.  Based on studies and literature, the panel concluded:

  • PTT is a viable treatment option to modestly improve penile length
  • PTT can be used adjunctively before Penile Prosthesis (PP) surgery in men with decreased penile length or after surgery for Peyronie’s disease (PD) to optimize patient outcomes
  • PTT can correct curvature in men presenting during the acute phase of PD
  • The benefits of PTT in men with PD in the chronic phase are unclear

See Reference 23

Please Note: RestoreX is only intended for the treatment of deformities associated with Peyronie’s disease.

Peyronie’s disease has two distinct phases characterized by different symptoms. In the early, also called the acute, phase men may experience painful erections, a plaque or bump in the penis, a curved (bent) erection, or a combination of these factors. Not all PD patients experience penile pain or discomfort; however, when present, the pain typically ends 12 to 18 months after the disease starts. In addition, many men notice a decrease in the length of their penis over the first 18 months.

The late or chronic phase begins approximately 6 to 18 months after the first symptoms. During the chronic phase, pain and inflammation typically end and a bend in the penis becomes evident and may worsen. Penile curvature will rarely improve during the late phase of the disease.

Physicians refer to Peyronie’s disease as a sustained or progressive disease. Regardless, the belief that PD will resolve without treatment over time persists. This belief sometimes presents an obstacle to early treatment that may benefit many men.

Although not all men with Peyronie’s disease will experience worsening erections, in some cases, Peyronie’s can severely deform the penis.  This can result in narrowing, buckling or softening of erections. Peyronie’s may also result in painful erections or tenderness at the location of the plaque which may also worsen erections. The misconception that PD is not associated with ED may contribute to a delay in men seeking treatment for the condition. Sometimes patients are misdiagnosed with ED instead of PD. Over half of men reported sexual function worsened over the course of the disease.

Peyronie’s disease can happen to men at any age but is most common among those ages 40 – 60.  It is more common in Caucasians, those who have undergone pelvic surgeries like a prostatectomy, and among those men with certain health conditions such as diabetes.5,6,8,24,25

The causes of PD are not completely understood but it is believed that it originates from trauma or repeated microtrauma to the erect penis in genetically susceptible men, leading to symptoms such as inflammation, a lump or plaque in the shaft, pain, and deformities of the penis such as curvature.

PD can cause anxiety, depression, low self-worth, and compromise men’s relationships. Although not much research has been done, it is believed that early identification and treatment of PD may dramatically improve psychological distress particularly for patients who receive timely information and reassurance about the disease and its treatment options. 9-12

Oral Supplements, Injections and Minimally Invasive Treatments

Supplements and vitamins during the initial onset of PD attempt to reduce swelling, pain, and plaque. No oral therapies have been definitively shown to improve the condition, including curvature, penile length or overall disease progression.

Penile injections are often prescribed to treat PD and may include Xiaflex, interferon or verapamil. Xiaflex has been cleared by the FDA to treat PD and has demonstrated improvement in penile curvature without impacting penile length or pain. Since the introduction of Xiaflex, interferon and verapamil are less commonly used in current practice.

Likewise, other minimally-invasive techniques such as extracorporeal shockwave therapy (ESWT) may be used to improve pain but are not recommended to treat penile curvature or plaques. Similarly, a trial including iontophoresis with or without verapamil injections demonstrated minimal improvement relative to no treatment at all.

The role of vacuum erection devices in treating Peyronie’s disease is currently unknown.  Although a small study suggested improvements when used early in the disease process, it did not include a control group, and therefore the benefits are unclear.26, 27

Surgery

Surgery is considered the gold-standard therapy for men with PD which has not responded to conservative treatment. To undergo surgery, PD must be stable for at least 6-12 months. The surgical procedure performed depends on several factors including the amount and location of the bend, erectile function prior to PD, patient goals, and surgeon preference. Although surgery corrects curvature in the majority of cases, it may lead to irreversible side effects in some cases including decreased penile length/volume, decreased penile sensation, erectile dysfunction, or recurrence over time. Perhaps because of these side effects, fewer than 30% of men with PD choose to undergo surgery.

Penile Traction Therapy

Penile traction therapy (PTT) consists of any treatment designed to lengthen or straighten the penis through mechanical forces. PTT is increasingly popular because of its relatively non-invasive nature, low cost, and minimal side effects and the lack of good alternatives to restore lost penile length.

The scientific basis for use of traction therapy is well established.  Traction creates mechanical stresses that alter cellular function particularly in cases of fibrosis and, as a result, re-orient collagen fibrils.1,2

Several clinical studies have demonstrated the potential benefits of PTT on curvature correction and restoration of penile length in men with PD.  In an early study without a control group, traction improved curvature and length.  The study was too small, however, to determine if these findings were due to chance alone.28  In a larger study of men with chronic PD (average duration of 16 months), PTT improved length compare to baseline.29  One study which specifically evaluated men in the acute phase of PD demonstrated significant improvements in penile curvature. Other studies have also shown possible roles for PTT with other conditions including as a primary lengthening therapy, for use prior to penile prosthesis placement, or as a temporary or long-term treatment after PD surgery.30-34

 

In 2015, a consensus panel convened to “summarize the current literature and provide clinical guidelines on penile traction therapy, vacuum erection devices, and penile revascularization.” Consensus panels are convened frequently because “the field of sexual medicine is continuously advancing, with novel outcomes reported on a regular basis. Given the rapid evolution, updated guidelines are essential to inform practicing clinicians on best practices”.

The panel held its meeting during the 2015 International Consultation on Sexual Medicine (ICSM) and the results were published in The Journal of Sexual Medicine in 2016.

Regarding Penile Traction Therapy and based on the literature present at the time of their meeting, the panel made these summary recommendations regarding traction therapy.

  1. Penile traction therapy (PTT) is a viable treatment option to modestly improve penile length (level of evidence (LOE) = 2; strength of recommendation = B; recommended).
  2. Penile traction can be used adjunctively before penile prosthesis (PP) placement in men with decreased penile length or after surgery for Peyronie’s disease (PD) to optimize patient outcomes (level of evidence (LOE) = 3; strength of recommendation = C; Option).
  3. PTT can correct curvature in men presenting during the acute phase of PD (level of evidence (LOE) = 2; strength of recommendation = C; Option).
  4. The benefits of PTT in men with PD in the chronic phase of disease are unclear (LOE) = 3; strength of recommendation = C; Option).

Trost LW, Munarriz R, Wang R, Morey A, Levine L. External Mechanical Devices and Vascular Surgery for Erectile Dysfunction. The journal of sexual medicine. 2016;13: 1579-617.

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[3] Laios K, Tsoucalas G, Karamanou M, Androutsos G. Peyronie’s disease in Minoan art. The journal of sexual medicine. 2013;10: 3144-5.

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[5] Kadioglu A, Tefekli A, Erol B, Oktar T, Tunc M, Tellaloglu S. A retrospective review of 307 men with Peyronie’s disease. The Journal of urology. 2002;168: 1075-9.

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[9] Smith JF, Walsh TJ, Conti SL, Turek P, Lue T. Risk factors for emotional and relationship problems in Peyronie’s disease. The journal of sexual medicine. 2008;5: 2179-84.

[10] Gelbard M, Lipshultz LI, Tursi J, Smith T, Kaufman G, Levine LA. Phase 2b study of the clinical efficacy and safety of collagenase Clostridium histolyticum in patients with Peyronie disease. The Journal of urology. 2012;187: 2268-74.

[11] Gelbard MK, Dorey F, James K. The natural history of Peyronie’s disease. The Journal of urology. 1990;144: 1376-9.

[12] Nelson CJ, Diblasio C, Kendirci M, Hellstrom W, Guhring P, Mulhall JP. The chronology of depression and distress in men with Peyronie’s disease. The journal of sexual medicine. 2008;5: 1985-90.

[13] Martinez-Salamanca JI, Egui A, Moncada I, et al. Acute phase Peyronie’s disease management with traction device: a nonrandomized prospective controlled trial with ultrasound correlation. The journal of sexual medicine. 2014;11: 506-15.

[14] LaRochelle JC, Levine LA. A Survey of primary-care physicians and urologists regarding Peyronie’s disease. The journal of sexual medicine. 2007;4: 1167-73.

[15] Lindsay MB, Schain DM, Grambsch P, Benson RC, Beard CM, Kurland LT. The incidence of Peyronie’s disease in Rochester, Minnesota, 1950 through 1984. The Journal of urology. 1991;146: 1007-9.

[16] Dibenedetti DB, Nguyen D, Zografos L, Ziemiecki R, Zhou X. A Population-Based Study of Peyronie’s disease: Prevalence and Treatment Patterns in the United States. Advances in urology. 2011;2011: 282503.

[17] Schwarzer U, Sommer F, Klotz T, Braun M, Reifenrath B, Engelmann U. The prevalence of Peyronie’s disease: results of a large survey. BJU international. 2001;88: 727-30.

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[20] Mulhall JP, Creech SD, Boorjian SA, et al. Subjective and objective analysis of the prevalence of Peyronie’s disease in a population of men presenting for prostate cancer screening. The Journal of urology. 2004;171: 2350-3.

[21] Tal R, Heck M, Teloken P, Siegrist T, Nelson CJ, Mulhall JP. Peyronie’s disease following radical prostatectomy: incidence and predictors. The journal of sexual medicine. 2010;7: 1254-61.

[22] Arafa M, Eid H, El-Badry A, Ezz-Eldine K, Shamloul R. The prevalence of Peyronie’s disease in diabetic patients with erectile dysfunction. International journal of impotence research. 2007;19: 213-7.

[23] Trost LW, Munarriz R, Wang R, Morey A, Levine L. External Mechanical Devices and Vascular Surgery for Erectile Dysfunction. The journal of sexual medicine. 2016;13: 1579-617.

[24] Mulhall JP, Schiff J, Guhring P. An analysis of the natural history of Peyronie’s disease. The Journal of urology. 2006;175: 2115-8; discussion 18.

[25] Grasso M, Lania C, Blanco S, Limonta G. The natural history of Peyronie’s disease. Archivos espanoles de urologia. 2007;60: 326-31.

[26] Nehra A, Alterowitz R, Culkin DJ, et al. Peyronie’s disease: AUA Guideline. AUA; 2015.

[27] Raheem AA, Garaffa G, Raheem TA, et al. The role of vacuum pump therapy to mechanically straighten the penis in Peyronie’s disease. BJU international. 2010;106: 1178-80.

[28] Levine LA, Newell M, Taylor FL. Penile traction therapy for treatment of Peyronie’s disease: a single-center pilot study. The journal of sexual medicine. 2008;5: 1468-73.

[29] Gontero P, Di Marco M, Giubilei G, et al. Use of penile extender device in the treatment of penile curvature as a result of Peyronie’s disease. Results of a phase II prospective study. The journal of sexual medicine. 2009;6: 558-66.

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[32] Oderda M, Gontero P. Comment on: applying extender devices in patients with penile dysmorphophobia: assessment of tolerability, efficacy, and impact on erectile function. The journal of sexual medicine. 2015;12: 1248.

[33] Levine LA, Rybak J. Traction therapy for men with shortened penis prior to penile prosthesis implantation: a pilot study. The journal of sexual medicine. 2011;8: 2112-7.

[34] Rybak J, Papagiannopoulos D, Levine L. A retrospective comparative study of traction therapy vs. no traction following tunica albuginea plication or partial excision and grafting for Peyronie’s disease: measured lengths and patient perceptions. The journal of sexual medicine. 2012;9: 2396-403.