Peyronie’s Disease

Overview of Peyronie’s Disease

Peyronie's Disease versus Normal
Peyronie’s disease is characterized by a plaque, or hard lump, that develops on the upper or lower side of the penis in layers containing erectile tissue. It starts with an inflammation and can develop into a hardened scar. Symptoms may develop slowly or appear overnight and they consist of reduced flexibility, pain, curved and shortened penis during erection. The curvature of the penis generally leads to lowered self-esteem and makes sexual intercourse difficult for many, almost impossible for some.

Some of the factors involved in Peyronie’s disease can be: trauma, infection, genetic predisposition, vascular problems, consumption of specific medicines, diabetes, hypertension, etc. The plaque itself is benign, or noncancerous. However, if not treated, the disease may lead to serious erectile dysfunction.

Between 3-9% of Adult Male Population Suffer from Peyronie’s Disease

Of these, the following have experienced conditions such as:

Chart 80%
up to 80% of men with Peyronie’s disease have erectile dysfunction
Chart 80%
80% of men with Peyronie’s disease report emotional problems
Chart 70%
70% of men with Peyronie’s disease report relationship problems
Chart 36%
36% of men with Peyronie’s disease report interference with sexual activity
Chart 70%
up to 70% of men with Peyronie’s disease have a history of related pain

Treatment

In a small percentage of men, Peyronie’s disease goes away on its own. But for the great majority of men, treatment is required. Nonsurgical treatment is almost always recommended in the first 12 to 18 months of treatment. After nonsurgical treatments, in spite of potential serious risks, surgery is recommended which is the most effective way to treat Peyronie’s disease. Currently there is only one FDA approved treatment. While not considered a surgical procedure, this treatment requires up to eight injections (four treatment cycles) in the penis and depends on an enzyme effect. Its use is limited to men with a palpable plaque and curvature deformity of 30 degrees or greater upon erection at the start of therapy. A penile modeling procedure is recommended after every treatment cycle of two injections. By comparison, Hybrid Medical’s H-100™ is a topical solution simply applied to the skin surface in the privacy of the home and is intended to be used by all who have Peyronie’s disease.

Medications

A number of medications have been studied for Peyronie’s disease, including L-Carnitine, colchicine, aminobenzoate potassium, tamoxifen and vitamin E. There is little evidence that using any of these is better than watchful waiting.

Injections

Doctors have tested injecting drugs directly into the scar tissue (plaque). Two have been found to have some positive effect:

  • Verapamil, a drug usually used to treat high blood pressure, stops creation of collagen — a part of the plaque — and promotes transformation of scar tissue into normal tissue
  • Interferon injections have been shown to reduce collagen formation

There is one FDA approved injectable treatment which is described above. Side effects of this injectable treatment can include hematoma, pain at injection site and erectile dysfunction. Serious side effects such as penile fracture and allergic reactions are possible.

Iontophoresis

Iontophoresis uses an electric current to administer a combination of verapamil and a steroid noninvasively through the skin. Early research shows the treatment to be somewhat effective.

Other therapies

Verapamil has also been tried as a gel, rubbed on the penis. With presently available gels there is little evidence to show that the drug reaches the diseased tissues of the penis. Shock wave therapy has been tested as a means of breaking up plaques, but effectiveness has been inconsistent.

Surgery

Surgery is the most effective way to correct the penile curvature associated with Peyronie’s disease. You would be considered a candidate for surgery if:

  • You’ve had Peyronie’s disease for more than one year
  • You’re unable to have satisfactory sexual intercourse
  • Your disease is painless and stable

Reconstructive surgery for Peyronie’s disease is a complex operation, requiring specialized techniques and experience. Some urologists have achieved a high rate of success using surgery to restore the normal shape and function of the penis in men with Peyronie’s disease.
Different surgical procedures are available, depending on each man’s symptoms and needs.

Phase I – Acute (0-18 months)

  • Can last up to 18 months
  • Is when most changes to the penis occur
  • Plaque(s) and curvature may develop
  • Pain often occurs with or without an erection

Phase II – Chronic (18+ months)

  • Typically occurs 12 months after symptoms
  • Plaque and curvature not likely to worsen or improve
  • Penile pain may diminish
  • Acute phase may return if another injury occurs

Risks

Risks of surgery for Peyronie’s disease include:

  • Diminished penile sensation
  • Shorter penis
  • Impaired ability to achieve an erection
  • Return of the curvature in rare instances

With the surgical choice a patient also has to deal with the cost of surgery, insurance issues and recovery time.

As indicated above, nonsurgical treatments are the preferred initial treatment. Hybrid Medical has developed a topical solution that can effectively deliver therapy to diseased tissue. Surgery is only considered when men with Peyronie’s disease do not respond to conservative medical therapy for approximately 1 to 1.5 years and cannot perform satisfactory sexual intercourse. A noninvasive treatment, such as that designed by Hybrid Medical, is the initial treatment of choice.

Disease Prevalence

Per the National Institute of Health the prevalence of Peyronie’s disease is 3%-9% in adult men [1] Table 1 shows prevalence population for various world markets.

Geographical Area 3% Prevalence 9% Prevalence
Table 1 – Peyronie’s disease: Select geographical populations

1. Hellstrom WJ, Medical management of Peyronie’s disease. Int J Impot Res. 2005 Nov-Dec;17(6):550-2. ; Also: NIH: Trost LW, Gur S, Hellstrom WJ, Pharmacological Management of Peyronie’s disease. 2007;67(4):527-45.; also Gur S Current status and new developments in Peyronie’s disease: medica, minimally invasive and surgical treatment options. Expert Opin Pharmacother, 2011 Apr; 12(6):931-44, Pubmed.gov

U.S. 2,760,720 8,282,160
Europe 6,376,352 19,129,055
Asia 38,543,160 115,629,479
Australia/New Zealand 231,715 695,146
South America 3,511,964 10,535,893
World 104,486,820 313,460,460

Research Findings

A 2007 journal publication states that patients who are diagnosed under the age of fifty have a greater probability that the disease will worsen, requiring a surgical approach.

A 2006 journal publication reported the most common presenting symptom was erectile dysfunction. The notching deformity was more frequently localized at the base and tip of the penis.

A 2007 journal publication states the onset of the disease may be gradual or sudden and is often, but not always, accompanied by penile pain made worse by sexual activity. The inflammatory process leading to scar formation and penile deformity is self-limited, and the pain typically resolves with time. Unfortunately, the deformity remains in 90-95% of patients.