XIAFLEX for Peyronie’s Disease

XIAFLEX is an innovative therapeutic option that has recently emerged as the treatment of choice for the long term management of Peyronie’s disease in men. Peyronie’s disease is a slow but progressive condition of penis that is characterized by abnormal fibrotic changes in the corpus cavernosum of the penile tissue that may present as:

• Abnormal curvature of the penis
• Erectile dysfunction
• Penile pain

According to latest estimates, the prevalence of Peyronie’s disease in males is about 3-9% (1). The pathophysiology of Peyronie’s disease revolves around accumulation of plaques in the cavernous tissues of penis. This plaque is composed of tough collagen that greatly affects the flexibility and spongy structure of the male copulating organ. XIAFLEX is an investigational novel remedy which exert its action by softening/ degrading the collagen with the help of Clostridium histolyticum collagenase (2).

XIAFLEX Treatment For Peyronie's

Classically, XIAFLEX regimen is composed of (2):

• A maximum of 3 treatment cycles administered over 6 weeks.
• Each treatment cycle is composed of two injections (which are administered 1-3 days apart). A dose of 0.58 mg of collagenase C. histolyticum is given per injection.
• A strengthening exercise (modeling procedure) is done after administration of second injection.

Depending upon individual cases, physicians may modify or alter the procedure to minimize the risk of complications (2).

Benefits and Risks Associated with XIAFLEX

Study reported in The Journal of Urology (2) reported that XIAFLEX therapy improves the curvature deficits in patients of Peyronie’s disease by 32.5%. In untreated or placebo subjects, a worsening of curvature by 2.5% was observed; suggesting that XIAFLEX is an effective, non-surgical and minimally invasive procedure for the management of this condition.Latest research indicates that although XIAFLEX is highly effective in the long term control of penile fibrotic changes, yet clinical use is associated with following risks:

• Corporal Fracture: Serious injuries to penis (such as corporal fracture) is a common adverse effect in males who receive XIAFLEX injections. Research indicates that the risk of corporal trauma with mild penile pressure (such as during erection) limits the efficacy of this treatment. Surgical intervention can be performed to repair the corporal injury but in most cases, the effects are irreversible.
• Hematoma Formation: Hematoma may appear due to the accumulation of blood in the corporal tubes. This risk is higher in males with existing blood conditions (or those who are on anti-clotting treatments such as aspirin, prasugrel hydrochloride, clopidogrelbisulfate, warfarin etc.). In case of large hematomas, the mass may press upon penile vessels and may cause vascular damage. In advanced cases, hematoma drainage may be needed.

How can You Minimize the Risk of Adverse Effects?

Experts recommend that the response to the therapy and quality of results can be improved by following these simple tips:

• Individuals should avoid sexual encounters with their partner after receiving XIAFLEX therapy for a period of at least two weeks. It is always a good idea to consult with your primary care provider to know when to resume sexual activity.
• Avoid physical exertion or weight lifting until the pain and penile swelling subsides completely.

Healthcare providers also recommend penile stretching and strengthening exercises for early recovery:

Penis Stretching

• Hold the penis from its base with one hand while holding the tip with fingers of other hand.
• Move the penis from its tip, opposite to body so that it elongates and undergo stretching
• Hold the penis in stretched position for about 30 seconds
• Perform this exercise when the penis is erect (at least three times a day)

Penis Strengthening

• In case of spontaneous erection, other than due to sexual stimulation. Hold the penis from its shaft and move it in a opposite direction of the curve
• Move the penis gently in a way that the moving force does not elicit any pain.
• Hold the penis in this strengthening position for 30 seconds
• Do not perform this in absence of a spontaneous erection.

When to Expect After XIAFLEX Therapy?

Mild pain and transient swelling is common after XIAFLEX injection (that resolves spontaneously). Some patients also experience mild bruising for 12-24 hours. OTC (over-the-counter) medications can be taken to relieve the pain after consulting the doctor. You can also perform mild activities (as recommended by the physician) such as stretching and strengthening exercises of penis as discussed above. However, if you are experiencing any of the symptoms listed below; seek immediate medical assistance:

• A popping sensation/ sound in the penis (especially during an erection)
• Inability to maintain and achieve normal erection
• Swelling of penis
• Appearance of purple bruising over the penile surface
• Difficulty in passing the urine
• Constant pain in penis or aggravation of discomfort/ pain with erection

Besides Peyronie’s disease, XIAFLEX can also be used effectively for the management of other fibro-proliferative conditions such as Dupuytren’s contracture.References:

1. Gur, S., Limin, M., & Hellstrom, W. J. (2011). Current status and new developments in Peyronie's disease: medical, minimally invasive and surgical treatment options. Expert opinion on pharmacotherapy, 12(6), 931-944.
2. Gelbard, M., Lipshultz, L. I., Tursi, J., Smith, T., Kaufman, G., & Levine, L. A. (2012). Phase 2b study of the clinical efficacy and safety of collagenase Clostridium histolyticum in patients with Peyronie disease. The Journal of urology, 187(6), 2268-2274.
3. Goldstein, I., Karsh, L., Mills, J., Smith, T., Kaufman, G., & Shabsigh, R. (2014, April). Clinical Evaluation of Treatment of Peyronie’s Disease With Collagenase Clostridium Histolyticum: Analysis of Penile Curvature Deformity by Duration of Disease and Plaque Calcification. In JOURNAL OF SEXUAL MEDICINE (Vol. 11, pp. 170-170). 111 RIVER ST, HOBOKEN 07030-5774, NJ USA: WILEY-BLACKWELL.
4. Syed, F., Thomas, A. N., Singh, S., Kolluru, V., Hart, S. G. E., & Bayat, A. (2012). In vitro study of novel collagenase (XIAFLEX®) on Dupuytren's disease fibroblasts displays unique drug related properties. PloS one, 7(2), e31430.