Efficacy of a Novel CCH Protocol for PD Among Prior Non-responders
Peyronie's Disease
About this trial
This is an interventional treatment trial for Peyronie's Disease
Eligibility Criteria
Inclusion Criteria:
- Men with Peyronie's Disease
- >18 years old
- Curvature ≥30 degrees
- Previously completed 6-8 CCH injections
- Prior minimal (<20% and/or <10 degrees) responsiveness to CCH administration
- Prior CCH injections must have been performed without use of a Restorex traction device and used the IMPRESS protocol
- Ability to achieve an erection satisfactory for intercourse with or without PDE5 inhibitors
- The patient exhibits a palpable plaque consistent with Peyronie's Disease
Exclusion Criteria:
- Prior surgical treatment on the penis (other than circumcision)
- Any contraindications to CCH - as determined by the PI
- Inability to complete 8 additional CCH injections
- Severe plaque calcification (i.e. >1 cm shadowing)
Sites / Locations
- The Male Fertility and Peyronie's ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Control - Crossover to CCH
Collagenase Clostridium Histolyticum
Men in this cohort would undergo baseline assessments followed by no treatment for 6 months and then repeat assessments. Men would then cross-over to CCH treatment and undergo up to 8 injections (or until curvature is <15 degrees). Final assessments would then be performed 6 weeks following the final injection.
Men in this cohort would undergo baseline assessments followed by up to 8 injections of CCH (or until curvature is <15 degrees). Men would then undergo assessments 6 weeks later, followed by a 6-month no treatment phase and then final assessments.