Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease

Launched by UNIVERSITY OF MIAMI · Mar 8, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a treatment called collagenase clostridium histolyticum (CCH) for men with Peyronie’s Disease (PD), which is a condition that causes a curve in the penis due to a buildup of scar tissue. The study will involve men who have previously received another treatment called Platelet Rich Plasma (PRP) injections to see how well CCH works after that treatment.

To be eligible for this study, participants need to be men aged between 18 and 80 who have been diagnosed with stable Peyronie’s Disease, have a noticeable curve of more than 30 degrees but less than 90 degrees, and have had PRP treatment in the last 18 months. Participants will receive CCH injections and will be monitored for any side effects or complications. It's important to note that certain medical histories, such as previous surgeries on the penis or severe erectile dysfunction, may exclude someone from participating. This study aims to help improve treatment options for men dealing with Peyronie’s Disease.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Be able to provide written informed consent
• • 2. Have a diagnosis of PD with evidence of stable disease as determined by the investigator
• • 3. Patient must have palpable penile plaque
• • 4. Penile curvature deformity of \>30° to \<90°
• • 5. Agree to comply with all study related tests/procedures.
• • 6. Prior intralesional platelet rich plasma treatment within the past 18 months and desire secondary treatment of penile curvature
• Exclusion Criteria:
• • 1. Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting, penile prosthesis.
• • 2. Previous intralesional injection therapy with CCH for PD within six months. Patients with failed therapy greater than six months ago may be included.
• • 3. Previous history of priapism or penile fracture
• • 4. PD characterized by a ventral plaque
• • 5. Severe erectile dysfunction as characterized with an IIEF score ≤ 12
• • 6. Hour-glass deformity
• • 7. Unwilling to participate
• • 8. Medically unfit for sexual intercourse as deemed by the principal investigator
• • 9. Patients scheduled to undergo an elective medical procedure during the investigation timeframe that will interfere with autologous PRP injection therapy.
• • 10. Have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.