Last updated on August 2019

Treatment Response to Xiaflex for Men With Peyronie's Disease


Brief description of study

Xiaflex, Collagenase Clostridium histolyticum (CCH) is the only FDA approved medical treatment for correcting penile curvature associated with Peyronie's disease. Xiaflex is efficacious in approximately 60% of patients with an average improvement in penile curvature of 17 degrees as defined by global response assessment.

Previous analysis indicate that men who were more likely to demonstrate a greater response to Xiaflex were those men with: 1) penile curvature 30-60; 2) disease duration >4 years; 3) no plaque calcifications; and 4) IIEF score 1-5 (no sexual activity) and 17.

Current evaluation of Peyronie's Disease at the University of Miami incorporates the use of penile duplex ultrasound following administration of intracavernosal vasoactive agent.

The investigator hypothesize that men with thicker plaques with more shadowing as seen on ultrasound imaging. The investigator will test the hypothesis using the following aims:

  • To identify the prevalence of different types and grades of plaques among men with PD
  • To identify pre-treatment factors those predict response to Xiaflex, specifically ultrasonographic characteristics

Detailed Study Description

Xiaflex, Collagenase Clostridium histolyticum (CCH) is the only FDA approved medical treatment for correcting penile curvature associated with Peyronie's disease.

Xiaflex is efficacious in approximately 60% of patients with an average improvement in penile curvature of 17 degrees as defined by global response assessment. Identifying predictors of Xiaflex non-response is extremely important, as the treatment is expensive, time- consuming, and may, in some cases be associated with severe adverse effects such as penile pain, hematoma and penile fracture. Prospectively identifying men who are likely to benefit from CCH therapy would provide significant benefits, in terms of safety, resource allocation, and personalized treatment.

Previous analysis indicate that men who were more likely to demonstrate a greater response to Xiaflex were those men with: 1) penile curvature 30-60; 2) disease duration >4 years; 3) no plaque calcifications; and 4) IIEF score 1-5 (no sexual activity) and 17.

Multiple imaging modalities have been evaluated in Peyronie's disease, including ultrasound, CT and MRI. Current evaluation of Peyronie's Disease at the University of Miami incorporates the use of penile duplex ultrasound following administration of intracavernosal vasoactive agent Duplex ultrasound serves two purposes. The first goal of ultrasound is to evaluate underlying vasculogenic etiologies in patients with Peyronie's disease and identify any co-existent erectile dysfunction. The second goal is to characterize the size and location of the plaque.

Ultrasound has been used to categorize Peyronie's plaques based upon the amount of calcification within the plaque: Type 1: The plaque appears as a thickening of the tunica albuginea without acoustic shadowing. Type 2: A moderately calcified plaque with a typical ultrasound shadow. Type 3: A severely calcified plaque with typical ultrasound shadowing. This will be referred to "Pawlowska Type". A second plaque categorization scheme (plaque grading) was proposed by Levine in 2013 that looked at the size of the plaque calcification on ultrasound: grade 1 (<0.3 cm), grade 2 (>0.3 cm, <1.5 cm), grade 3 (>1.5 cm; or 2 plaques >1.0 cm). This will be referred as "Levine Grade". In Levine's study, the focus was on progression to surgery and never specifically evaluated the use of Xiaflex.

The investigator hypothesize that men with thicker plaques with more shadowing as seen on ultrasound imaging (Pawlowska type 2 and 3) and larger plaques (Levine grade 2 and 3) will have less improvements in curvature and PDQ score after Xiaflex treatment. Whereas thinner (Pawlowska type 1) and less calcified (Levine grade 1) will have greater improvements in curvature (degree and percent) and PDQ score. The investigator will test the hypothesis using the following aims:

  • To identify the prevalence of different types and grades of plaques among men with PD
  • To identify pre-treatment factors those predict response to Xiaflex, specifically ultrasonographic characteristics

Clinical Study Identifier: NCT03774264

Find a site near you

Start Over