Introduction: Since the FDA approval of Collagenase Clostridium Histolyticum (CCH) for the treatment of Peyronie’s Disease (PD), several investigators have reported outcomes of CCH, with improvements ranging from approximately 15-30%. More recently, we reported improved results (49% mean improvement) when CCH was combined with RestoreX penile traction therapy (RxPTT). Since then, we have made additional modifications to create a more aggressive injection / traction protocol to further optimize outcomes. The objective of the current study was to report outcomes of a more aggressive CCH injection / traction protocol in men with PD.
Methods: A prospective database has been maintained of all individuals undergoing CCH injections since 2014. Our CCH injection protocol has evolved from the one described in the IMPRESS trials to a more aggressive use of injections and manual and mechanical traction. Currently, the protocol consists of injecting 0.9 mg of CCH in 0.7 ml of saline into approximately 15-20 sites around the point of maximal curvature (pharmacologically-induced erection performed with the first injection of each series). Injections are only performed on subsequent days (not 2-3 days apart), and very aggressive (i.e. 10-15 lbs of force) modeling is performed with the 2nd injection. Patients are counseled to begin RestoreX traction at 24-48 hours after the 2nd injection for 30-60 minutes daily, and to continue aggressive manual modeling for at least the first week post injection. Penile wraps are applied for 5 days post injection. A descriptive analysis was subsequently performed to review outcomes.
Results: A total of 438 men underwent at least 1 series of CCH and had baseline and follow-up curve assessment data available. Mean age was 55.8, with a mean PD duration of 32 months and a median baseline composite curvature of 64 degrees. Using the definition of most recent curve assessment, mean composite curve improvements were 27.1 degrees (41%) with the new technique vs 17.8 (24.6%, p<0.001). Of men who completed all 8 injections or stopped early due to satisfaction, the mean improvements were 36.4 degrees (59%) vs 19.8 (30.5%, p<0.001). Despite the more aggressive stretching and traction protocol, erectile function was similar to baseline (IIEF-EFD +0.5).
Conclusions: Implementation of a more aggressive CCH injection protocol has resulted in improved curvature outcomes. Given the specialized nature of technique modifications described, these results would argue for a center-of-excellence model for CCH administration to achieve optimal outcomes.
.jpg)
.jpg)