In the standard protocol outlined by the IMPRESS (Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) trials, each patient receives a total of eight injections, split into four cycles of two injections (0.58 mg), given 24-72 hours apart at six week intervals . During the 24-72 hour post-injection period, either the patient or the physician performs penile modeling to enhance plaque disruption. While this protocol has demonstrated clinical efficacy, there are several drawbacks. First, the standard protocol utilizes small concentrations of CCH, making it difficult to adequately distribute the drug over a wide area of the curvature apex. Second, intralesional injection of CCH causes a local inflammatory reaction that can make it difficult to palpate the plaque for the second injection after 24-72 hours. Furthermore, 24-72 hours may not be enough time for the inflammation at the injection site to subside before the next injection, potentially contributing to penile bruising and pain. Third, the standard protocol requires 14 patient visits over a 24-week period, which can be a significant burden on patients from a cost and time perspective.
A new shortened modified protocol was introduced and tested by Raheem et al. in 53 patients with PD, and the study represents a potential shift in the administration of this minimally invasive treatment option . In this shortened protocol, each cycle consisted of only one injection with a larger dose of CCH (0.9 mg; whole vial). This method allows higher concentrations of CCH to be delivered to the plaque while limiting the inflammatory changes that occur with additional injections. Limiting the frequency of injections in the modified protocol and having patients complete the modeling themselves at home also allows patients to complete treatment with only four patient visits over a 12-week period. This undoubtedly improves compliance and reduces costs associated with CCH treatment. More importantly however, this shortened modified protocol demonstrated a mean curvature reduction of −17.4° (−31.4%) from baseline, which is comparable to the results obtained in the IMPRESS trials [2, 4]. Moreover, there was an improvement in each of the International Index of Erectile Function (IIEF) questionnaire domains, all 3 PDQ domains, and the global assessment of the PDQ.
CCH continues to be a gold standard minimally invasive treatment for PD; however due to its cost and adherence to completing all four cycles, it can be logistically difficult for some patients. The new shortened modified protocol addresses these issues without sacrificing clinical efficacy by reducing curvature and improving PDQ bother domains.
In addition to new developments in the administration protocol, studies are starting to increasingly broaden inclusion criteria to include patients with acute phase disease and atypical plaques. In a recent study published by our group, we found that the use of CCH in the acute phase of PD had similar safety and efficacy outcomes compared to those treated in the stable phase of the disease . Additionally, studies are starting to utilize CCH to treat atypical presentations of PD, including ventral plaques, hourglass deformities, and multiplanar plaques. Roughly 10% of patients present with atypical PD and suffer greater burden of disease than typical PD counterparts. Milam et al. administered four cycles of CCH to two patients with ventral plaques and saw significant improvement in penile curvature without serious adverse events . These studies show promise that CCH can be safely given to patients that do not meet the inclusion criteria outlined in the IMPRESS trials.
Further randomized-controlled studies assessing the durability of the shortened modified protocol and the use of CCH in acute phase and atypical PD are warranted.
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Written by: Andrew T. Gabrielson, Laith M. Alzweri, Wayne J.G. Hellstrom, Department of Urology, Tulane University School of Medicine, New Orleans, LA, USA
Corresponding Author: Wayne J.G. Hellstrom, MD, FACS, Tulane University School of Medicine, Department of Urology, Tulane University School of Medicine, New Orleans, LA, USA
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