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XIAFLEX: A New Treatment for Peyronie's Disease

Peyronie's Disease is a local connective tissue disorder characterized by a change (scar formation) in the collagen composition of the tunica albuginea of the penis.

The two corpora cavernosa and corpus spongiosum of the penis are composed of an elastic covering within the tunica on top of the erectile-spongy tissue inside. During an erection, blood is trapped in all three corporal bodies leading to dissension of the corpora and an erection occurs. Peyronie's plaque, which is composed predominately of collagen, although calcium deposits may occur, replaces the normal elastic tissue. This results in penile deformity, primarily a curvature (I have seen up to 120 degree bends!); along with penile narrowing, indentation and shortening of the penis.

ETIOLOGY

Microvascular trauma resulting from excessive bending or injury to the penis (possibly during sexual activity) is thought to be an important trigger for the inflammatory response and plaque development. Genetic pre-disposition and autoimmunity may also play a role in the development.

IMPACT AND RAMIFICATIONS

Sexual intercourse: As one can imagine, the deformity can result in inability to penetrate or function properly. If the deformity is severe enough, pain to the partner as a result of the penile glans pushing on the vaginal vault side wall can occur.
Erectile dysfunction: An increase in incidence of erectile dysfunction has been associated with Peyronie's Disease. With the use of PED5 inhibitors or 2nd/3rd tier treatments, a more rigid erection can result which can lead to an exacerbation of the penile deformities.
Psychological: As one can imagine, the potential psychological effects to a man can be devastating. Recent studies showed that 48% of men with Peyronie's Disease were found to have clinically meaningful depression.

TREATMENTS

Old time treatments, including Vitamin E, Potaba, and anti-inflammatories, have been tried but have not been shown to be clinically effective.

Penile injections of steroids and Interferon have been used with limited success. Probably the gold standard has been the use of Verapamil injections into the plaque. This has been reported, with and without the use of a vacuum erection device, to improve the deformity in some men. This requires a penile block followed by injection of 10-20 mg. of Verapamil every other week for a total of 12 treatments. Studies have reported a 30 degree improvement in the curvature in some men.

The basis of the use of Verapamil is that it breaks up the collagen fibers leading to an improvement in the deformity. A number of compounding pharmacies have attempted to create a Verapamil cream to replace the intra-lesional injection of Verapamil with limited success.

Surgical options include a simple procedure in which stitches are used to straighten the penis but this does result in some shortening of the erection (about an inch or so). The only other option is a penile prosthesis which for some men with associated ED is a viable treatment. However, placing implants with Peyronie's is not necessarily an easy procedure.

THE NEW TREATMENT: XIAFLEX

Xiaflex (collagenase clostridium) has been approved in the past for the treatment of Dupuytren's contractions with significant success. The theory is that the collagenase breaks up the collagen fibers resulting in a relief and improvement in a deformity associated with this condition.

Recently, Texas Urology participated in a clinical trial with use of Xiaflex for Peyronie's Disease. Based on the results of two studies involving over 600 men, Xiaflex has been approved for the treatment of Peyronie's Disease. In the two clinical trials, a 35% improvement was noted in men with a penile deformity of at least 30 degrees (placebo improvement approximately 20%). Additionally, there was an improvement in the Peyronie's bother domain compared to placebo.

Corpora rupture (penile fracture) was reported in 0.5% of men with Xiaflex. Additionally, greater than 25% of the men reported an incident greater than placebo of penile hematoma, penile swelling and penile pain.

In Xiaflex administration/home treatment, a solution of 0.25 cc of reconstituted collagenase is injected into the plaque at the point of maximum deformity (based on a pharmacological-induced erection). A second injection into the plaque is repeated 1-3 days later both in the office. The patient returns to the office 1-3 days later for penile modeling which involves stretching the penis in the flaccid state along with bending for approximately 30 seconds and then repeated twice with 30 second rest periods. The patient then proceeds for six weeks to perform penile modeling activities at home which include stretching the penis for 30 seconds, three times a day and penile straightening at least once a day for 30 seconds. The patient should abstain from sexual activity for at least two weeks. Up to four treatment cycles may be administered per plaque.

The treatment should not be attempted for ventral plaques but only for dorsal plaques because of the urethral location ventrally.

BOTTOM LINE

Xiaflex appears to be of benefit to men with significant penile deformities (greater than 30 degrees) who are interested in improving their curvature. The cost of Xiaflex per treatment cycle is $3,900 per treatment course cash price. Since it is a new medication insurance coverage will take time, but supposedly it is covered by Medicare. Remember it could take four courses!

This could be a high price to pay in many ways, but for men with a significant problem it may be well worth it.

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