Ramasamy, Ranjith

Abstract Purpose The purpose of this white paper is to educate health care professionals about the evolution of telemedicine (TM) and to propose a hybrid model that leverages the strengths of traditional in-person medicine as well as virtual medicine while maximizing the safety and quality of men’s sexual health care. Literature Search Strategy A literature search focused on the use of TM in urology and men’s health was performed through PubMed/MEDLINE, Embase, and Web of Science (January 1, 2012–April 26, 2022). Keywords included all known permutations of the terminology used to refer to virtual health, care as well as the terminology used to refer to urologic diseases, issues specific to men’s health, and men’s sexual health concerns. Publications that emerged after the literature search that met this criterion also were incorporated. Opinion pieces, letters to the editor, meeting abstracts, and conference proceedings were excluded. Additional resources were retrieved, such as governmental technical reports, legislative updates and reviews, and blogs. This search strategy yielded 1684 records across databases after removal of duplicates. Abstracts from the retrieved records were reviewed for relevance. Relevant publications were defined as those that reported data on any aspect of TM use specific to urology, men’s health, and/or men’s sexual health. If relevance was unclear from the abstract, then the full text of the article was retrieved for a more detailed review. In addition, the published evidence-based practice guidelines relevant to care for erectile dysfunction, Peyronie’s disease, ejaculatory dysfunction, and hypogonadism were retrieved. The most common reasons for article exclusions were a focus on TM use in disciplines other than urology and the absence of data (ie, opinion pieces). After exclusions, a total of 91 publications remained and constituted the evidence base for this paper.

Abstract Introduction Peyronie’s disease (PD), estimated to affect around 10% of the male population, is an acquired disorder of penile fibrotic tissue. The only FDA approved medical treatment for PD is Intralesional Collagenase Clostridium Histolyticum (CCh). CCh is a mixture of AUX1 and AUXII, two different forms of collagenase that cleave collage type I and type III, leading to plaque degradation. PD plaques, however, also contain fibrin and calcium which CCh is unable to digest. It is unknown if plaque calcification prevents collagenolysis with CCh. Objective To determine if calcification prevents collageolysis of PD plaques with CCh. Methods Calcified PD plaques were collected from five males undergoing excision and grafting for PD. Control tissue was collected from five males undergoing penile implant surgery for erectile dysfunction, with no known history of PD. Tissue samples were then divided into equal weights and incubated with CCh or PBS for 24 hours. The CCh or PBS was injected into the tissue (control or plaque) to mimic administration of CCH for treatment of PD. Following incubation, the fluid (CCh or PBS) was measured for soluble collagen amount and tissue was subjected to Picrosirius Red and H&E staining. Results There was a higher concentration of soluble collagen in the tissue (control and plaque) incubated in CCh (301ug, SD 21.1) compared to the issue incubated in PBS (32.5ug, SD 3.7) (p=0.02). Additionally, there was less type 1 and 3 collagen present in the CCh condition (mean 0.12, SD=0.08), when compared to the PBS condition (0.44, SD=0.17) (p=0.002). However, when comparing within the CCh condition to look at differences between tissue types (calcified vs. control) no differences were found. There was a similar amount of soluble collagen in the CCh control condition (316ug, SD 35) and the CCh calcified condition (286ug, SD 11) (p=0.06). Similarly, the PBS control condition (30ug, SD17) and the PBS calcified condition (35ug, SD 48) were found to have no significant differences in collagen concentration (p=0.4). Finally, there were no significant differences found in type I/III collagen staining between tissues in the CCh condition, with control (0.08, SD=0.02) and calcified (0.17, SD=0.09) demonstrating no significant difference (p=0.08). Tissues in the PBS condition, control (0.5, SD=0.23) and calcified (0.39, SD=0.39), similarly were not significant (p=0.2) (table 1). Conclusions CCh is capable of breaking down collagen in calcified plaques. Further research into CCh as a treatment option for PD calcified plaques is necessary. Disclosure Yes, this is sponsored by industry/sponsor: Endo Pharmaceuticals Clarification Industry funding only - investigator initiated and executed study Any of the authors act as a consultant, employee or shareholder of an industry for: Acerus Pharmaceuticals, Boston Scientific, Coloplast, Endo Pharmaceuticals, Empower Pharmacy, Nestle Health, Olympus, Hims, Inc.

Abstract Introduction Current non-invasive treatments for erectile dysfunction (ED) include oral medications, intracavernosal injections, and vacuum-assisted devices. Though these therapies work well for many, a subset of patients have contraindications or are unsatisfied with these options. Restorative therapies for ED are a new frontier of treatments focused on regenerating diseased tissue and providing a potential “cure” for ED. Aim The aim of this position statement is to examine existing clinical trial data for restorative therapies and identify elements that require further research before widespread adoption. Methods A literature review was performed to identify all clinical trials performed with regenerative therapy for ED. This includes treatments such as stem cell therapy (SCT), platelet rich plasma (PRP), and restorative related technologies like low-intensity shockwave therapy (LiSWT). Main Outcome Measures Most clinical trials in restorative therapies were assessed for safety, feasibility, or efficacy. This included recording adverse events, changes in sexual function and erectile function questionnaires, and diagnostics measures. Results To date there is an absence of robust clinical data supporting the efficacy of restorative therapies regarding ED, though technologies such as LiSWT have established relative safety. Conclusions Restorative therapies are a promising technology that represents a new frontier of treatment geared towards reversing disease pathology rather than just treating symptoms. However, current published clinical studies are limited. Future work needs to be adequately powered, multi-center, randomized, sham/placebo-controlled trials in well-characterized patient populations to ensure safety and demonstrate efficacy. Until these studies are done, restorative therapies should be reserved for clinical trials and not offered in routine clinical practice.