Treatment Response to Xiaflex for Men With Peyronie's Disease
Status:
Recruiting
Trial end date:
2020-12-02
Target enrollment:
Participant gender:
Summary
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