Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional Platelet Rich Plasma for Peyronie's Disease
University of Miami
Summary
The purpose of this study is to learn about the safety and side effects of intralesional collagenase clostridium histolyticum (CCH) injected into the Peyronies Disease (PD) plaque after receiving prior treatment with intralesional Platelet Rich Plasma (PRP) injections.
Eligibility
- Age range
- 18–75 years
- Sex
- Male
- Healthy volunteers
- No
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,…
Interventions
- DrugCollagenase Clostridium Histolyticum (CCH)
Injection of intralesional CCH (0.58mg) to the penile plaque at the point of maximal curvature. Second injection of each cycle will be injected 2-3mm apart from the prior injection.
Locations (2)
- University of Miami - Desai Sethi Urology InstituteMiami, Florida
- University of MiamiMiami, Florida