Investigation of Surgery, Collagenase, and Restorex for the Improvement of Peyronie's (iSCRIP)
Peyronie's Disease
About this trial
This is an interventional treatment trial for Peyronie's Disease focused on measuring collagenase clostridium histolyticum, RestoreX, plication, incision and grafting, surgery
Eligibility Criteria
Inclusion Criteria:
- Men with PD
- >18 years old
- Curvature ≥30 degrees
- Ability to achieve an erection satisfactory for intercourse with or without PDE5 inhibitors
Exclusion Criteria:
- Prior treatment with CCH or surgery
- Moderate (shadowing) or severe (>1 cm) penile calcification
- Any contraindications to CCH, PTT, or surgery - as determined by the PI
Sites / Locations
- The Male Fertility and Peyronie's Clinic
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
CCH+PTT
Surgery+PTT
Men will receive two injections of CCH administered 1-3 days apart, followed by manual modeling and PTT 30-60 min/day as outlined in our prior publication. Approximately 6 weeks later, the next round of injections will be performed until a maximum of 8 injections in total has been administered. PTT will be continued until the 3-month post-treatment visit.
Men will undergo either penile plication or I&G based on appropriate clinical criteria for either surgery. 2-4 weeks post-operatively (depending on tolerability), the patients will be asked to perform PTT 30-60 minutes daily until the 3-month post-treatment visit.