(115) Side Effect Profile of Collagenase Clostridium Histolyticum for Peyronie’s Disease Significantly Affects Long-term Patient Satisfaction
Authors: Song J , Dai M , Naeem T , Saffati G , Khera M , Lipshultz L 
Published: February 2024

Abstract

Introduction
Collagenase Clostridium histolyticum (CCH) is the only FDA-approved medication for Peyronie’s Disease (PD) in the United States. While treatment-related side effects are commonly considered mild or moderate in severity, including bruising, pain, and swelling, there is currently limited literature on how these side effects affect patient satisfaction, especially long-term satisfaction, with CCH treatment.

Objective
The aim of this study was to better understand the side effect profile of CCH treatment for PD and its effects on long-term satisfaction with CCH treatment.

Methods
An Institutional Review Board approved retrospective chart review and standardized questionnaire was conducted for all patients with PD who received CCH from 2009-2022. Patients who received CCH before presenting to our institution were excluded. The questionnaire utilized the Treatment Satisfaction Questionnaire for Medication (TSQM), which is validated across the subdomains of satisfaction with effectiveness, side effects (SE), convenience, and global satisfaction (GS), and summed to generate the TSQM total score. Statistical analyses were performed in R using Wilcoxon rank sum test and independent T-test to compare continuous variables with TSQM scores, and Spearman’s rank correlation to compare categorical variables with TSQM scores.

Results
Of the 243 eligible patients, 80 (32.9%) responded (Table 1). Of these, 34 (42.5%) reported satisfaction with CCH treatment. On average, surveys were completed 4.7 (SD 2.3) years after last CCH injection. Patients experienced an average of 2.2 (SD 1.5) notable side effects, and increased number of side effects was significantly correlated with decreased scores of SE subdomain, convenience subdomain, and TSQM total (Spearman's ρ= –0.46, –0.29, –0.28; p&lt;0.009 for all). Most common side effects noted were bruising, swelling, and pain with injection (Table 2). Other than swelling, all SE noted were associated with significantly lower SE subdomain scores (p&lt;0.03 for all). New erectile dysfunction (ED) was correlated with the largest reduction in the TSQM total score (mean 105.4 ED vs. 192.1 no ED, p=0.006). Hematoma and pain with injection were the only other side effects associated with significant reductions in the TSQM total score (p=0.03 for both), and experiencing no SE was correlated with significantly increased TSQM total scores (mean 256.1 no SE vs. 166.7 SE, p=0.003). When rating pain with injection on a scale 1 to 5, mean rating was 3.1 (SD 1.2), and rating was significantly associated with scores of SE subdomain, convenience subdomain, and TSQM total (Spearman's ρ= -0.33, –0.52, –0.33; p&lt;0.003 for all).

Conclusions
Our data suggests that impairment of sexual function through new ED has the most significant negative impact on long-term overall satisfaction with CCH treatment, followed closely by pain with injection and hematoma. Though the latter two side effects are typically considered mild to moderate in severity, they continue to profoundly impact overall satisfaction nearly five years after completion of CCH treatment.

Disclosure
Any of the authors act as a consultant, employee or shareholder of an industry for: M.K. acts as a consultant for AbbVie, Marius, Tolmar, Endo, Petros, Boston Scientific, Coloplast. M.K. is an investor of Sprout. L.L. acts as a consultant for AbbVie, Aytu BioScience, Contraline, Lipocine. L.L. acts as an advisor for Inherent Bioscences. L.L. acts as consultant/speaker for Endo Pharmaceuticals. L.L. acts as a speaker for American Medical Systems/Boston Scientific.