Xiaflex® Treatment for Peyronie's Disease May Improve Penile Curvature Degree With No Effect on the Loss on Penile Length in Post-marketing Analysis

Abstract

ABSTRACT Introduction One of the main complaints of patients with Peyronie's Disease (PD), besides the curvature, is penile shrinkage. Both deformities result in significant distress to the patient and his partner. XIAFLEX has been developed to treat Peyronie's plaques with substantial improvement of the curvature in the IMPRESS TRIAL. Objective In this study, we perform a post-marketing analysis to see if there is any significant improvement of stretched penile length, erect penile length and erect circumference in patients who respond to XIAFLEX compared to patients who do not. Methods Consecutive patients treated with XIAFLEX for dorsal plaque and penile curvature above 30 degrees in the absence of hourglass deformity were included in this study. Penile curvature was assessed using a goniometer after induction of artificial erection using alprostadil, before treatment, and eight weeks after the end of the 4th cycle. Stretched and erectile length, as well as erectile circumference, were measured at the same setting. Based on the results of the IMPRESS trial, we decided that any improvement over 15 degrees was deemed a positive response (given our initial measurements were in increments of 5 degrees). Results 148 patients with PD and penile curvature above 30 degrees elected and completed 4 cycles of non-surgical intervention were included in this study. In this cohort, 129 (87%) of patients had improvement over 15 degrees after completing eight total injections of Xiaflex. The average penile curvature at the beginning of the study was 61.4 degrees, while stretched penile, erected penile length, and erected circumference were 13.9 cm, 13.3 cm, and 11.8 cm respectively. The figure shows no significant change in neither the erect nor the stretched penile length in patients who responded to the injections. However, there was a significant decrease in the erect circumference in the majority of patients from an average of 11.8cm to 9.3cm. Conclusions There appears to be no significant regain of the penile length in which patients often complain about losing due to Peyronie's disease in those who respond to Xiaflex injections. The study finding suggests that the erect circumference might decrease, not necessarily due to the injection itself but due to the disease or recovery process. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Endo Pharmaceuticals