Xiaflex for Peyronie’s Disease

by Dr. Alex Shteynshlyuger MD

If you have any questions, to schedule a consultation or if you need a second opinion, please contact us or call: 646-663-4050

Dr. Alex Shteynshlyuger is a board-certified urologist in NYC who specializes in treating men with Peyronie’s disease.

What is Xiaflex?

Xiaflex is a brand name for collagenase (USA; in Europe the brand name is Xiapex), a naturally occurring enzyme that is involved in tissue repair.  XIAFLEX is the first medication FDA approved for treatment of Peyronie’s disease.  It is effective for the treatment of moderate to severe Peyronie’s Disease.

Xiaflex is a naturally occurring enzyme called collagenase. Collagenase breaks down collagen which is a protein that is present in scar tissue.  By breaking scar tissue, Xiaflex treats the cause of Peyronie’s disease directly.

Peyronie's TreatmentWho is a Candidate for Xiaflex/Xiapex Treatment?

FDA approved XIAFLEX for use in men with at least 30-degree penile curvature and a palpable plaque (which is necessary to inject into it). Read more about Xiaflex treatment for Peyronie’s disease and our patient selection criteria for Xiaflex.  Men should be able to obtain good erection on their own or with the help of medications such as Viagra or Cialis.  Men should NOT have significant hourglass narrowing of the penis.

How is Xiaflex Administered?

Xiaflex is administered by injecting the active medication into the Peyronie’s plaque in the penis.  Usually, the administration is done in combination with penile plaque modeling. Read our detailed explanation of the treatment approach and treatment schedule.

Pain and Anesthetic Expectations:

Xiaflex injection involves a needle injection – usually, there is some discomfort but fairly tolerable for a minute or so that it takes to inject the medication.   There is no general anesthesia (you’re fully awake) but we can give a local anesthetic if you wish. The patient can walk in and walk out of the office.  The pain is what you would expect from an injection.  Patients cannot have sex for 2 weeks after each injection due to the risk of penile fracture.

Xiaflex Success Rates

Success rates vary but studies demonstrate an average 34% improvement in the curvature (or 17-degree decrease from baseline curvature).  60% of men getting Xiaflex experienced improvement compared to 30% with placebo.  Our experience with Xiaflex suggests that success rate depends on the patient’s disease severity.  

Many patients with Peyronie’s are not ideal candidates for Xiaflex due to plaque calcification.  Patients who are not ideal candidates for Xiaflex typically experience less benefit from Xiaflex.

What are the Risks of Xiaflex?

Randomized controlled trials revealed that there are a number of risks associated with injection of Xiaflex in the penile plaque.  These include bruising, hematoma, penile swelling, penile pain as well as a number of other common side effects.  A significant and concerning side effect that has been noted in less than 1% of men who received Xiaflex is rupture of the corpora albuginea.  This is a major reason that the FDA has approved Xiaflex with the requirement for careful administration by properly trained and experienced urologists.

  • Penile hematoma (bruising, hematoma): 66% – usually minor goes away after 1-2 weeks
  • Severe penile hematoma: 6% goes away after 1-2 weeks
  • Penile Swelling: 55%  goes away after 1-2 weeks
  • Penile Pain: 45%
  • Painful erection: 3%
  • “Popping sounds or cracking sounds”: 13%

Corporal rupture: 0.5% (occurs typically within first 2 weeks after injection; for this reason, no sex is allowed for 4 weeks after each injection).  

What is the Procedure for Getting Treated with Xiaflex for Peyronie’s Disease?

Initial evaluation requires 1-3 visits to determine if you’re a good candidate for Xiaflex (have a good chance of benefiting from it).  Usually, you would need a consultation during which we would need to administer an injection to create an artificial erection so that we can properly evaluate the plaque and see if you’re a good candidate for Xiaflex or any other treatments.  Penile Doppler ultrasound is performed.

If you are a candidate for Xiaflex and decide to proceed, usually we can get the medication delivered within 2 business days.  Read more about costs and insurance coverage. The treatment cycle is approximately 7 days. Injection on day 1; then another injection on day 2-3; then penile remodeling 3-4 days later.

You then are taught to do remodeling by yourself for 7 weeks at home; then a 2nd cycle is given again over a period of 1 week followed by 7 week period of self-remodeling for 4 cycles total. So each cycle is spread by 7 weeks from the next one.  If your curvature becomes <15 degrees then we stop it. The maximum we can do is 4 cycles.  For patients with multiple plaques, if there is a good response, additional treatment can be tried.

Costs of Xiaflex is usually covered by insurance including by most major health insurances in the USA. There are some insurance companies outside the US that may pay for treatment in the US with Xiaflex. The company that makes Xiaflex has a program where they can check your insurance benefits and negotiate with the insurance company to see if they pay for it.

How Effective is Xiaflex for Treatment of Peyronie’s Disease?

Randomized controlled studies show that Xiaflex is one of the most effective medications for treatment of Peyronie’s disease in men.  Overall around 60% of men who are ideal candidates for Xiaflex experience some benefit from treatment with Xiaflex. Success rates are lower for patients who are not ideal candidates for Xiaflex.

Xiaflex Treatment Schedule

Xiaflex is administered in 4 cycles, each cycle is one week long followed by 7 weeks of at-home penile self-remodeling.  Overall it takes close to 6 months to administer the full cycle.  Patients who prefer faster results may consider other treatment options.

At New York Urology Specialists, our Xiaflex treatment schedule includes an initial evaluation to determine if Xiaflex is an appropriate option for the individual man who comes to us with Peyronie’s disease. Some men may be better served with other treatment options for Peyronie’s disease. International patients may undergo initial evaluation in their home country from a local urologist experienced in the treatment of Peyronie’s disease.

Peyronie's treatmentWho is a Candidate for Xiaflex?

Not every patient with Peyronie’s disease is a candidate for Xiaflex.  Currently, men with Peyronie’s with greater than 30-degree angle are candidates.  Men should be able to obtain good erections to qualify.

The plaque cannot be close to the urethra. The indications for using Xiaflex is curvature greater than 30 degrees, preferably with minimal calcification.

Because the medication works to break up proteins it may not work well (or at all) in heavily calcified plaques (these were excluded from studies). The plaque also needs to be palpable so that we know we are injecting in the right space. There are some additional criteria. Read about our qualifications for Xiaflex treatment.

Costs and Insurance Coverage for Xiaflex (Peyronie’s Disease)

The cost of medication is significant. The good news for men with Peyronie’s disease is that most insurances provide coverage for Xiaflex, including Medicare, UnitedHealthCare, Aetna, Blue Cross plans and many others.  We work through the Xiaflex Experience program to get your insurance to cover the costs of treatment.  Insurance coverage may also be available for some of our international patients. Read more about costs and insurance coverage for Xiaflex.

Patients with no insurance or high deductible may be well served by other cost-effective treatment options for Peyronie’s disease.

If you have any questions, to schedule a consultation or if you need a second opinion, please contact us or call: 646-663-4050

Dr. Alex Shteynshlyuger is a board-certified urologist in NYC who specializes in treating men with Peyronie’s disease.