Our team has previously demonstrated efficacy in performing a novel collagenase Clostridium histolyticum (CCH) injection protocol in men who previously failed to achieve a response to an initial 4 series of CCH.
The objective of the current study is to evaluate a protocol that incorporates limited in-office modeling for up to 4 series, followed by up to 2 additional salvage series to determine safety and efficacy compared to historical data.
Participants will receive up to 4 series of CCH injections using our previously published protocol, with mild in-office modeling. CCH injections are given on back-to back days, after which they are counseled to utilize Restorex and sildenafil daily, as instructed. Patients will undergo mild in-office modeling on day 2.
The sexual partners of study participants will also be invited to enroll in the study and will complete non-validated questionnaires detailing their level of support for the patient's treatment.
Men with Peyronie's Disease
Older than 18 years old
Curvature ≥30 degrees
Ability to achieve an erection satisfactory for intercourse with or without phosphodiesterase-5 (PDE5) inhibitors
Prior surgical treatment on the penis (other than circumcision)
Prior treatment with CCH injections
Any contraindications to CCH - as determined by the PI
Charitable Union for the Research and Education of Peyronie's Disease
Lead sponsor
Endo USA Inc., a Keenova Therapeutics Company
Collaborator