Xiaflex: the first non-surgical treatment for acquired peyronie’s disease or curved penis

Peyronie's Disease

According to urologists, about 10% of men have a medium-high curve in the penis. However, peyronie’s disease or acquired curvature of the penis affects less than 5% of men.

This disease of unknown origin causes a fibrous band in the corpora cavernosa of the penis. These hardened areas lead to a curve in the erect penis. Erections can be painful and, depending on the degree of the curve, can prevent penetration, causing serious damage to the sexual health of the patient.

andromedi placas fibroticas en la enfermedad peyronie 01

Fibrotic plaques in Peyronie’s disease 01

andromedi placas fibroticas en la enfermedad peyronie 02

Fibrotic plaques in Peyronie’s disease 02

Treatments

Despite being a fairly widespread disease, so far the common treatment is surgery to correct the curve, usually by plication techniques. This intervention corrects the curve, however it does not eliminate the damaged tissues. This solution causes a shortening of the penis and, in many cases, erectile dysfunction problems. However, there are improvements developed by Dr. Cruz, chief surgeon at the Andromedi Clinic in Seville that reduce shortening when applying this type of treatment.

It can also be treated by iontophoresis in its initial stages, achieving good results and eliminating those fibrous bands that cause the curve.

A new treatment: Xiaflex

The Xiaflex, technically called “Collagenase clostridium histolyticum”, and better known as Xiapex in Europe, is manufactured and marketed by Auxilium Pharmaceuticals and Pfizer.

It was approved in 2010 by the Food and Drug Administration (FDA) for the treatment of Dupuytren-type contracture. This disease of unknown origin causes a gradual closing of the hand by retraction of the superficial palmar aponeurosis.

Since its approval for this disease, the FDA has been asked to approve it for peyronie’s disease. In fact, 30% of patients with peyronie’s disease have revealed a hardening of scar tissue in other parts of the body such as the hand or foot.

The composition of Xiapex/Xiaflex is of biological origin and is made from the protein contained in the organism “collagenase clostridium histolyticum”. Its function is to break down collagen protein.

andromedi tratamiento no quirurgico peyronie 01

Non-surgical peyronie treatment

Just a few days ago (December 6) Xiaflex was approved by the FDA for the treatment of peyronie's disease, becoming the first and only non-surgical treatment for this disease.

Its marketing in injectables requires, of course, a doctor’s prescription. In addition, doctors must be authorized for the application of this new drug. It is injected directly into the penis or over the affected areas. The treatment consists of four phases or cycles. Each treatment cycle includes two Xiaflex injections. A total of eight injections are given during the course of treatment.

Penis shaping (gentle stretching in the opposite direction of the deformity) is recommended after each treatment cycle to further alter the plaque. In fact, clinical trials have used this technique in conjunction with injections.

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En cumplimiento del Reglamento General de Protección de Datos le informamos que los datos por Vd. proporcionados serán objeto de tratamiento por parte de Andromedi con la finalidad de prestarle el servicio solicitado y/o contratado. Los datos no se cederán a terceros salvo en los casos en que exista una obligación legal. Para más información puede consultarla pinchando aquí.

Results

The safety and efficacy of the drug has been tested in various clinical trials conducted by BioSpecifics in collaboration with Auxilium Pharmaceuticals.

The sample used was more than 800 patients at 64 sites in the U.S. and Australia, with a 2:1 ratio of XIAFLEX versus placebo.

Patients had a penile curve of at least 30 degrees in the first two IMPRESS trials (I and II).

Xiaflex was injected twice a week every six weeks. All four treatment cycles were applied and each treatment cycle was followed by a penis modelling procedure by a specialist.

The average deformity of the penis at the beginning of the trial was 48.8 degrees and at the end of the 52 weeks it was 31.0 degrees, so the average reduction is 37.6% in penile curvature. The average reduction in the placebo group was 21.3% (49.0 degrees to 39.0 degrees). The average deformity of the penis at the start of the second round of the trial was 51.3 degrees and at the end of the 52 weeks 35.1 degrees, so the average reduction is 30.5% in penile curvature. The average reduction in the placebo group was 15.2% (from 49.6 degrees to 41.1 degrees).

andromedi como medir una curva de pene 01 1

How to measure a penis curve

The most reliable and long-lasting alternative for the time being is still surgery.

Palliative treatments of the acquired penis curve such as Xiaflex or iontophoresis can be very helpful in the early stages of the disease, but not very helpful when the plaques generated by Peyronie have advanced to gain consistency and size.

In these cases, surgery is the only real way to recover a satisfactory sexual life, as it reduces the deviation of the penis to a ratio of practically 0-10%. The postoperative period is not excessively annoying, and following the advice and indications of the medical team, the return to sexual normality is achieved after only one month.

In the following video you can learn more about this disease:

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Author

Dr. Natalio Cruz


Natalio Cruz MD, with 25 years of medical experience, has been until 2016 Head of the Andrology Unit in the Urology Service of the Virgen del Rocío Hospital in Seville, National Coordinator of Andrology in the Spanish Association of Urology (AEU) and General Secretary in the ESSM, positions that he has narrowed to focus squarely on this exciting project of offering a high-level private medical consultation in Seville, Madrid and Tenerife.

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