Intralesional injection therapy provides a minimally invasive option for PD patients who would like to avoid surgery. Currently, among therapies reviewed (collagenase Clostridium histolyticum (CCh) (Xiaflex, Endo Pharmaceuticals, Dublin, Ireland), verapamil, IFN-a-2b, OnabotulinumtoxinA (Botox) (AbbVie, Chicago, Illinois), Hyaluronic acid), the only FDA approved intralesional treatment is CCh, which is off-label for atypical PD patients.
Since most studies followed IMPRESS I&II criteria, only a minority of studies (15 out of 488) included atypical PD patients. A total of 250 patients with atypical PD out of 1,357 were treated with intralesional therapies, majority 162 (648%) of the patients were treated with CCh, 49 (19.6%) with verapamil, 29 (11.6%) with interferon alfa-2b, 5 (2.0%) with hyaluronic acid, and 5 (2.0%) with onabotulinumtoxinA. Interestingly, there were no reports of urethral injury and only one case of penile fracture requiring surgical intervention.
This is the first systematic review of the literature (1982-2020) of all intralesional injection therapies for atypical PD. This review highlights in an eloquent way a gap in the literature related to lack of standardized classification system with clear and consistent definitions of different rare atypical PD presentations and the need for future studies to specifically include cohorts of atypical PD patients.
Although the authors demonstrated great effort in avoiding reporting redundant data, there were multiple inherent limitations that the authors acknowledged; heterogeneity related to the retrospective design, confounding effects of concurrent penile stretching and some studies did not report some common complications like pain and bruising.
The review supports the notion that intralesional injection therapy could be a safe option for patients with atypical PD, in addition, CCh has a comparable efficacy and safety profile to the general PD population. The development of standardized classification systems for definitions of atypical PD and reporting of complications related to intralesional therapy would pave the way for future advances in PD clinical research.
Written by: Laith Alzweri, MD, MRCS, FECSM, Director of Men’s Health, Assistant Professor of Urology, Dept. of Surgery, The University of Texas Medical Branch
Read the Abstract