Does Treating a Penile Plaque with Collagenase Clostridium Histolyticum Lead to Changes in Vascular Characteristics?

Abstract

ABSTRACT Introduction Peyronie's Disease (PD) is a localized disease of the Tunica albuginea (TA) characterized by the formation of fibrotic plaque. Patients with PD present with erectile dysfunction (ED) up to 32% of the time. We have presented in previous studies that the most common etiology of ED in this population is vascular leak characterized by elevated end-diastolic velocity (EDV) on penile duplex doppler ultrasound (PDDU). It is postulated that the change in the architecture of the TA could be the cause of this venous leak; however, this is not definitive. XIAFLEX, which is a collagenase clostridium histolyticum, has been used in clinical practice since 2013 to dissolve the abnormal deposition of collagen type I and III, which is the predominant type in the fibrotic plaque. Objective In this study, we explore if there is a change in mean EDV and rate of vascular leak measured on PDDU before and after receiving four cycles of XIAFLEX in patients treated for Peyronie's disease. Methods All patients presenting to our institution with chief complaints suggestive of PD undergo PDDU as part of the initial evaluation. Patients who are eligible and choose to get Xiaflex underwent four cycles of treatment, each consisting of two injections 24-72 hours apart. They then undergo another PDDU 8 weeks after completing the last cycle to assess response to treatment. Peak systolic velocity, EDV, resistive index, curve degree, and direction are usually recorded during the test at 0, 5, 10, 15, and 20 min after injection of a vasoactive agent. The lowest value recorded of EDV at times 10, 15 or 20 min at the time of maximal tumescence/rigidity was chosen for the analysis. Results We identified 223 patients with PD who underwent XIAFLEX treatment with 148 completing all 4 cycles at our center between 2016 and 2020. All patients had complete data available for analysis. 87% of patients showing improvement of equal to or more than 15 degrees after four cycles of treatment. The mean EDV at the initial PDDU was 26.7, while the mean EDV at the follow-up study was 13.9 (image 1). The rate of the non-vascular PDDU findings increased after XIAFLEX treatment with initial study containing 38% as compared to 48% on follow up (p-value: 0.044). Conclusions The mean EDV and the rate of the venous leak seem to decrease with the treatment of XIALFEX for Peyronies disease. Whether this is related to change in the architecture of the plaque or improved erectile function in general due to psychological and various factors in the patient who experience improvement in the curve is to be further explored. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Endo Pharmaceuticals