Short History Of Peyronies
Peyronies AKA bent nail disease was originally described by Guilio Cesare Aranzi as a rare affection of the genitals in people with excessive sexual intercourse. A small tumor like a bean in the flaccid penis which causes a deformity similar to a ram horn during erection in 1587. It was not given its current name until later when the surgeon to King Louis XIV, François Gigot de la Peyronie described the cases of three men with fibrous, thickening of the penile shaft with painful erections and penile curvature in 1743 some one and a half centuries later.
To give sexual pleasure is a gift; however there may be some instances when the reproductive system may be afflicted by disease. Peyronie’s disease is one of these diseases which typically affect men aged 40 to 70 years old, yet may also occur in younger men.
Symptoms Of Peyronies
Peyronie’s disease is an abnormal curvature of the penis shaft which can bring about painful erections and areas of thickening on the body of the penis. This creates an angulation in the penis, further causing erectile dysfunction, because of the resultant buckling of the penile shaft or the lack of rigidity along the area of thickening. The area of thickening may cut off the blood supply of the penis, thus causing erectile dysfunction.
Throughout the years, research has focused in discovering new medical and surgical treatments for this condition. However, the etiology of Peyronie’s disease remains a mystery. There are some studies which have attributed this disease to Vitamin E deficiency, while some have linked it to the use of beta-blocker medications for hypertension. Some studies have linked Peyronie’s disease to the increase in serotonin levels in the body.
In patients with Dupuytren contractions, Peyronie’s disease may be present due to the presence of HLA-B7 in genes. Recently, more studies have shown that Peyronie’s disease may be due to trauma or injury to the penis especially to its blood vessels and its tissues. The injury leads to the release of cytokines, substances that activate connective tissue cells called fibroblasts. When activated, fibroblasts proliferate and produce collagen. Collagen is the matrix that makes up penile thickening in Peyronie’s disease.
Peyronie’s disease can also coexist with other conditions such as hyperlipidemia, diabetes, heart disease and hypertension along with erectile dysfunction. Risk factors for this medical condition include age, obesity, smoking, concomitant erectile dysfunction, dyslipidemia, diabetes and psychological disorders.
The disease can progress over many years. The thickening in the penis may become calcified throughout the years and the angulation may become stable. There may be spontaneous resolution in majority of cases, yet there may only be partial resolution of plaques. This is why medical intervention should be given as early as possible.
Pain may be felt in the penis, which becomes more intense during erections. The penis may have a certain angulation which may only be noticeable during an erection or when the penis is flaccid. The penis may also have a certain plaque that is present on one side of the angulation and an indentation in the shaft along the area of the plaque. As a result, it may have decreased erectile function due to its rigidity or its angulation. The pain associated with the disease may resolve spontaneously even without treatment.
Initially, Peyronie’s disease may bring about inflammation to the penis during the first 18- 24 months. There may be penile pain and a palpable nodule or mass in addition to an abnormal curvature. After this stage, the plaque may become stable and may calcify, harden and develop a certain angulation. The penis cannot erect well anymore during this stage. During the early stage (within the first 6 months), medical treatment is important. If medical treatment is not successful, it should be continued for greater than six months before considering surgery.
Currently, there is no optimal medical treatment for Peyronie’s disease. Pain relievers are usually given until the patient is pain-free and normal sexual function is resumed. Previously, treatment options were limited to verapamil creams and injections, vitamin E, PABA/Potaba, L-carnitine, supplements such as Vigrx Plus, traction devices and even surgery. Surgery carries a very high risk for impotence and shortening of the penis.
Potassium aminobenzoate (PABA or Potaba) is a form of vitamin B which has been known to have anti-fibrotic actions. It is known to take up oxygen in the tissues, further enhancing the activity of monoamine oxidase which can help in the regression of fibrosis (hardening of the tissues). Some studies have actually noted reduction in pain, improvement of penile curvatures and decrease in plaque size. The drawbacks of this kind of treatment are that it has to be taken for 6 months and that a lot of gastrointestinal side effects may happen.
Another treatment currently being studied is the non steroidal anti-estrogen Tamoxifen which is said to help release transforming growth factor-beta from fibroblasts so that the inflammatory response may be lessened. Some studies have actually reported improvement in pain and curvature of the penis and reduction of penile plaques. Yet, other studies have conflicting results.
Other treatments include colchicine which may decrease collagen formation and stimulate collagenase activity to decrease the formation of plaques and fibrosis, steroids such as dexamethasone, verapamil (a calcium channel blocker that can break down collagen) and nicardipine injections.
In December 2013, the FDA approved a drug, collagenase clostridium histolyticum (Xiaflex), for the treatment of Peyronie’s disease. This treatment was previously given to patients with Dupuytren’s contracture, a medical condition wherein there is abnormal collagen buildup in the fingers, further causing permanent finger clenching.
Xiaflex is a proteinase that digests collagen that may be responsible for the curvature of the penis in Peyronie’s disease. The drug was approved due to two phase 3 studies (Investigation for Maximal Peyronie’s Reduction Efficacy and Safety Studies [IMPRESS I and II]). The studies gathered data from 832 men with Peyronie’s disease with penile curvature of at least 30 degrees. These subjects underwent four treatment cycles and were followed up after 52 weeks. The results showed that collagenase clostridium histolyticum (Xiaflex) was able to reduce deformities in the penis and other effects of Peyronie’s disease.
Indications for collagenase clostridium histolyticum treatment are palpable plaques in men with a curvature in the penis of at least 30 degrees at the start of treatment. It should only be given by a health care professional. One treatment cycle is composed of two injections and a procedure called penile modelling. A penile erection is usually induced prior to injection using a single penile injection of 10 or 20 micrograms of alprostadil. The penis is then marked on the plaque where collagenase clostridium histolyticum (Xiaflex) should be injected. When the penis is already flaccid, collagenase clostridium histolyticum (Xiaflex) is then given as an injection.
Collagenase clostridium histolyticum (Xiaflex) is then injected once a day for two days one to three days apart. After the second injection, a penile modelling procedure is performed using a traction device such as Proextender. Up to four treatment cycles may be given for each plaque causing the curvature. Cycles are repeated every six weeks. If the curvature is less than 15 degrees after the first, second or third treatment cycles, treatment may be discontinued.
Risks Of Xiaflex
The risks for collagenase clostridium histolyticum (Xiaflex) treatment include corporal rupture or fracture of the penis or any serious injury to the penis. This is why the drug should not be injected into the nerves, blood vessels, corpora cavernosa, urethra and other collagen-containing parts of the penis. Other side effects that may occur include hypersensitivity or allergic reactions. If you are using anticoagulants or if you have blood clotting disorders, you should consult your doctor first before undergoing treatment. The most common adverse drug reactions found in 25% of patients undergoing treatment are hematoma of the penis, swelling of the pains and pain in the penis. Other adverse events that may occur include itching in the penis and genitals, painful erections, erectile dysfunction, changes in the skin color of the penis, blisters in the penis, pain during intercourse or a nodule at the injection site.
The drawback of this treatment lies in the cost. Collagenase clostridium histolyticum (Xiaflex) costs around $3,500 per injection and may have a total average cost of $26,000 for 4 cycles or 8 injections. There may also be additional office charges and other administration fees which may be paid during the first and the succeeding 12 visits and during procedures that are relevant to the treatment cycles such as penis ultrasounds and injections. This is quite an expensive treatment procedure and the actual expenses may be unknown. This treatment option is certainly not for the masses until various health care providers and insurance companies are able to cover a part or all of the costs associated with this procedure.
Another drawback of collagenase clostridium histolyticum (Xiaflex) is that it is only available in some places. One has to find a qualified and experienced doctor or health professional who is certified to administer this treatment to patients.
Fortunately, there is insurance coverage for collagenase clostridium histolyticum (Xiaflex) treatment in all major insurance plans in the United States. Prior to coverage, the patient should obtain certification, which typically takes about one to two weeks. Outside the United States, there may be partial or full insurance coverage depending on the type of insurance company present in that country. Discounts may be given by the manufacturer and by various charitable institutions.
In conclusion, Peyronie’s disease is a treatable medical condition which can be reversed by the right treatment. Collagenase clostridium histolyticum (Xiaflex) is an approved treatment for this disease; however its drawbacks include the high cost that may only be partially covered by insurance plans. It would be favorable to its many sufferers if health care providers and insurance companies would be able to cover a huge part or all of the costs associated with this procedure.