Safety and Efficacy of Collagenase Clostridium histolyticum in the Treatment of Acute-Phase Peyronie’s Disease

Abstract

Background Peyronie’s disease (PD), defined as the abnormal formation of fibrous plaque(s) in the tunica albuginea of the penis, is a chronic condition that afflicts 3% to 13% of the US male population; there is no current research on the efficacy and safety of collagenase Clostridium histolyticum (CCH) in the treatment of acute phase PD. Aim To examine the efficacy and safety of CCH in the treatment of acute-phase PD. Methods We retrospectively reviewed the records for all patients treated with CCH for PD from April 2014 through April 2017. Patients who reported penile pain and duration of PD no longer than 12 months at presentation qualified as being in the acute phase of PD. The primary outcomes of interest were final changes in curvature after CCH treatment regardless of the number of CCH cycles received and frequency of treatment-related adverse events. Outcomes Parameters of efficacy and safety were compared between acute- and stable-phase PD. Results A total of 162 patients were included in the study, of which 36 (22%) qualified as having acute-phase PD (group 1) and the remaining 126 (78%) qualified as having stable-phase PD (group 2). Median duration of PD was 8.5 months (range = 1–12) for group 1 and 18 months (range = 1–492) for group 2. There was no significant difference in final change in curvature between the acute and stable phases of PD (16.7° vs 15.6°; P = .654). There was no statistically significant difference in frequency of treatment-related adverse events between the acute phase (4 patients, 11%) and the stable phase (12 patients, 10%; P = .778). Clinical Implications CCH therapy is as safe and efficacious in acute-phase PD as it is in stable-phase PD. Strengths and Limitations This is the first report that assesses the safety and efficacy of CCH therapy focusing on acute-phase PD. This study was composed of a large cohort of patients receiving CCH therapy in acute- and stable-phase PD. Limitations include bias associated with retrospective studies, a small sample, and a single-center setting. Conclusions Although CCH is not clearly indicated for treatment during the acute phase of PD, these results suggest that CCH use during this phase can be effective and safe. There was no statistically significant difference in final change in curvature or treatment-related adverse events after CCH therapy delivered between the acute and stable phases of PD.

Predictors of treatment success after collagenase Clostridium histolyticum injection for Peyronie's disease: development of a nomogram from a multicentre single‐arm, non‐placebo controlled clinical study

“…In the present cohort, 39% of patients received CCH at an early phase of PD (<12 months) and we showed that duration of the disease may influence treatment success. In contrast to the findings of the present study, Nguyen et al [25] demonstrated no statistical difference in CCH treatment efficacy between those in the acute phase of the disease and those in the stable phase. These discrepancies may be explained by the rigid definition of stable disease, which was based on the PD duration in that study, while we considered PD duration as a continuous variable, expressed in months, to be more accurate.…”

“…The angle of curvature was assessed, using a goniometer protractor, during erection after an intracavernous injection of prostaglandin E1. The IIEF-15 questionnaire considered the severity of erectile dysfunction, classified as follows: severe (score ≤10); moderate (scores 11-16); and mild (scores [17][18][19][20][21][22][23][24][25]. IIEF-15 sub-scores were also assessed, including IIEF-erectile function (IIEF-EF), IIEF-orgasmic function, IIEF-sexual desire, IIEF-intercourse satisfaction and IIEF-overall satisfaction.…”

Comparison of Intralesional Hyaluronic Acid vs. Verapamil for the Treatment of Acute Phase Peyronie's Disease: A Prospective, Open-Label Non-Randomized Clinical Study

“…Although surgery remains the gold standard treatment option for patients with stable PD, it is not recommended for men in the active phase. On the other hand, collagenase clostridium histolyticum (CCH) represents the only licensed drug for the minimally invasive treatment of PD [14,15], however the acute phase of PD is not currently an indication for CCH therapy [3,16,17]. Four studies [18][19][20][21] demonstrated significant improvements in penile curvature after 10 or 15 mg intralesional verapamil, although the protocols varied widely, ranging from 6 to 12 injections.…”

Medical Management of Peyronie’s Disease: Review of the Clinical Evidence

“…Small case series suggest that collagenase clostridium histolyticum is also effective in patients with acute phase disease [11,14]. While in one of these series, patients in the acute and chronic phases of Peyronie’s achieved a similar improvement in curvature (approximately 15°), the other patients in the acute phase benefited more (20° versus 13.9°).…”