(163) Efficacy of Collagenase Clostridium Histolyticum in Calcified Peyronie’s Disease

Abstract

Abstract Introduction Peyronie’s disease (PD) affects between 0.4% and 13% of the male population. It leads to inelastic scar tissue in the tunica albuginea which in turn leads to penile curvature, deformity, and shortening. Collagenase clostridium histolyticum (CCH) is the only FDA approved intralesional medication for PD, but its efficacy in calcified PD remains controversial. The two large, double-blind, placebo controlled randomized clinical trials, known as the IMPRESS trials, excluded men with calcified plaques, which occurs in 25-30% of all patients with PD. Objective We aimed to evaluate change in penile curvature in men with calcified PD plaques after 8 injections of CCH in a large cohort of men Methods We prospectively evaluated men with PD presenting to our clinic from October 2018 to November 2020 electing CCH treatment. All men received a pre-treatment penile duplex ultrasound with artificial erection to assess degree of calcification and curvature. We used a grading system to assess calcification: Type 1: The plaque appears as a thickening of the tunica albuginea without acoustic shadowing; Type 2: A moderately calcified plaque with a typical ultrasound shadow, and Type 3: A severely calcified plaque with complete ultrasound shadowing. All men received CCH (0.58 mg) injected directly into the primary plaque at the point of maximal penile curvature using a standardized injection technique following the manufacturer's instructions. Cycles were terminated early if the patient was satisfied with the curvature or subjects reached less than 15 degrees. We remeasured the curvature in patients 4-6 weeks after the final CCH with artificial erection. All results are presented as mean ± standard deviation (SD) Results In total, 60 patents presented with calcified PD plaques with 32 (53.3%) receiving all 8 injections and another 5 patients were satisfied with results and elected to stop treatment. The remaining 23 (38.3%) discontinued before finishing; on average they received 5.6 injections. There were no differences in baseline characteristics between men who completed treatment and those that discontinued. In patients who were satisfied there was significant (p<0.0001) mean change per subject of -21.6 ± 19.9 degrees or 37.3% (Table 1). In the discontinued there was a mean change per subject of -12.8 ± 13.9 degrees (p=0.05). There was no significance difference in change in curvature between grade 2 (-24 ± 14.9 degrees) and grade 3 (-21.3 ± 23.4 degrees) calcified plaques (p=0.71) (Table 1). Conclusions Overall, CCH appears effective in the treatment of patients with calcified PD plaques. In patients who successfully completed 8 injections or was satisfied there was a significant difference in curvature after treatment and can help inform patients about treatment benefits despite calcification. Disclosure Yes, this is sponsored by industry/sponsor: Endo Pharmaceuticals Clarification Industry funding only - investigator initiated and executed study