Collagenase clostridium histolyticum intralesional injections for the treatment of Peyronie’s disease: a safety profile

tau.amegroups.com © Translational Andrology and Urology. All rights reserved. Peyronie’s disease (PD) is a debilitating chronic condition associated with penile curvature, erectile dysfunction, pain, and emotional distress (1). The condition was first described in 1743 by Francois Gigot de la Peyronie, King Louis XV of France’s physician (2). PD is a progressive condition characterised by fibrotic plaques within the tunica albuginea which can lead to pain and penile curvature (2). Non-surgical and surgical management options exist, with surgery often being offered in the most severe cases (1,3). Surgery carries the potential morbidity of penile shortening, neurovascular injury and erectile dysfunction (3). Established non-surgical management of PD includes oral therapy, intralesional injections and mechanical traction therapy, although the efficacy of such treatments are variable and debatable (4). The levels of evidence for such studies are low and often have inherent flaws in design. For example, penile traction therapy has been suggested to improve penile curvature by 22 degrees and improvement in plaque load on ultrasonography (5). However, this study like others was a small non-randomised prospective study, with evidence for penile traction therapy being largely based on small, retrospective studies (2). Scott & Scardino first described the use of Vitamin E as a non-surgical management of PD in the 1940s (2). Since then, studies have not shown evidence supporting the use of this as oral therapy. Hashimoto et al. published their retrospective study in 2006 demonstrating no statistically significant improvement in pain, penile curvature or erectile dysfunction in patients given Vitamin E compared to the placebo group (6). In 2007, Safarinejad et al. published their results from a double-blind randomized controlled trial, which showed no statistically beneficial effect of Vitamin E or propionyl-L-carnitine or the combination of both in treatment of PD (7). Phosphodiesterase Type 5 (PDE-5) inhibitors have also been suggested to improve penile curvature and plaque load, however, there is limited evidence for this and further level I evidence is needed to evaluate this (2). Teasley first reported on the use of intralesional injection of corticosteroids in 1952, this has since been concluded to show no clinical benefit with low level of evidence behind it (2). Other injectable agents include verapamil and interferon alpha-2B, which have both been shown to potentially provide benefit from randomized controlled studies, although the number of patients in these studies is relatively small (2). These studies have highlighted the need for more robust clinical trials and the need for a more efficacious non-surgical treatment intervention for the treatment of PD. More recently, Gelbard et al. published the results of the IMPRESS trial, reporting on the clinical efficacy of collagenase clostridium histolyticum (CCh) intralesional injections as a minimally invasive treatment option in PD (3). CCh is a purified mixture of AUX-I and AUX-II collagenases which act synergistically to enzymatically weaken the plaque in PD (3,8). CCh injections have been used in Dupuytren’s contracture for some years now, which is followed by a finger extension procedure (3). This biologic agent was recently approved by the U.S. Food and Editorial