Treatment Response to Xiaflex for Men With Peyronie's Disease

• Status: Recruiting
• Trial end date: 2020-12-02
• Target enrollment: 80
• Participant gender: Male

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Collaborator: Endo Pharmaceuticals

Criteria

Inclusion Criteria:

• Age ≥18 years

• Able to provide informed consent

• A stable relationship for ≥3 months

• PD symptoms for ≥12 months with evidence of stable disease as determined by the investigator

• Penile curvature deformity of >30° to <90°

• Has not had previous surgery for PD

• Has not had previous therapy with Xiaflex for PD

Exclusion Criteria:

• Ventral plaque

• Active phase PD

• Actively on anticoagulation during time frame of injections

• Aspirin 81mg will be eligible for therapy

• Hour glass deformity

• Previous allergic reaction to Xiaflex

• Unwilling to participate

• Medically unfit for sexual intercourse as deemed by the principal investigator

• Patients scheduled to undergo an elective medical procedure during the investigation timeframe that will interfere with Xiaflex injection cycles as deemed by the PI