Abstract Introduction Peyronie’s disease (PD) is a fibrosing condition of the tunica albuginea characterized by a palpable plaque with varying impacts on the patient’s erection: curvature, shortening, indentations, hinging, and concentric narrowing. Stepwise intralesional injection of collagenase clostridium histolyticum (Xiaflex) is the only FDA approved medical treatment for PD. We retrospectively reviewed Xiaflex treated patients for satisfaction with therapy or pursuit of subsequent surgery. Objective To assess satisfaction of Xiaflex treatment without subsequent surgical intervention. Methods This is a retrospective review of patients presenting with PD to a single center and managed by a single provider with six-month follow-up after treatment. Patient presentations were recorded in an Institutional Review Board approved database. Data storage and analytics were conducted using REDCap. Results The cohort for this study was 81 men treated with intralesional Xiaflex. 71.6% of patients (58/81) were satisfied with Xiaflex outcomes and sought no further therapy. 27.2% of patients (22/81) were not satisfied with their outcomes and 12 (14.8%) elected subsequent surgical interventions: 6 penile plications, 2 incision and graftings and 4 inflatable penile prostheses. 63.3% of patients had full (8) Xiaflex treatment. Among the 50 who had full Xiaflex treatment, 12% had surgery after Xiaflex. Among the patients who had partial Xiaflex treatment 20.7% had surgery following Xiaflex. The degrees of curvature in patients receiving Xiaflex was: < 60 (n = 42), ≥ 60 (34) and hourglass deformity (n = 4). Among the 12 patients who had surgery following Xiaflex, 6 men received 8 Xiaflex treatments, and 1 patient each received 2, 4, 5, 6, and 7 Xiaflex treatments. Conclusions If successful medical management of Peyronie’s disease is defined by men who do not seek subsequent surgical intervention following therapy, Xiaflex was highly successful. In our series of 81 patients, only 14.8% sought surgical interventions following intralesional collagenase histolyticum. Disclosure No.
Abstract Introduction Over/Under is a sportsbook wager term. Peyronie’s disease (PD) affects men of all ages with an estimated prevalence of up to 9% of the population. The Peyronie’s Disease Questionnaire (PDQ) Scale provides an opportunity to assess patient perception of their disease and the impact it has on quality of life. A potential discrepancy between patient-perceived and physician-measured curvature is important aspect of triaging care for patients with PD. Counseling, management and treatment risks are impacted by PD triage. Objective To investigate patient accuracy in perceived degree of curvature in Peyronie’s disease. Are patients over estimating or underestimating PD curvature? Methods A retrospective chart review was performed on 57 patients with diagnosis of Peyronie’s disease at our institution. Patients in the study completed a Peyronie’s Disease Questionnaire (PDQ) Scale with additional prompts including, but not limited to, penile curvature with erection, number of penile curvatures, and degree of each penile curvature. All patients had office based testing with intracavernous injection of Alprostadil and color duplex Doppler assessment (CDDU). The primary outcome was estimation of concordance of curvature estimated by patient and measured by provider. Patient overestimation was defined as perceived curvature more than 15 degrees greater than measured curvature. Underestimation was defined as patient-estimated curvature 15 degrees less than measured curvature. Results Of the 57 patients, 51 patients met study criteria with a completed questionnaire, documented physician-measured curvature, and absence of an hourglass deformity on examination. Patient concordance with physician-measure curvature within 15 degrees was observed in forty patients (78%). Overestimation of curvature was recorded in eight patients (16%), while three patients (6%) underestimated their curvature. Conclusions The PDQ Scale is a useful tool in assessing degree of curvature in patients with PD. We carefully selected men who had normal vascular erection responses to Alprostadil in office and compared provider measurements to patient’s home estimate of curvature. Our study finds that in men with no co-existing erectile dysfunction and no hourglass deformities the majority (78%) accurately estimate their penile curvature within 15 degrees of measured curvature. PDQ cannot replace physical examination of Peyronie’s disease or office based intracavernous induced erections as discordance between percieved and measured curvature is 22%. Disclosure No.
Fueling the Firefighter and Tactical Athlete with Creatine: A Narrative Review of a Key Nutrient for Public Safety
Background/Objectives: Firefighters, tactical police officers, and warriors often engage in periodic, intermittent, high-intensity physical work in austere environmental conditions and have a heightened risk of premature mortality. In addition, tough decision-making challenges, routine sleep deprivation, and trauma exacerbate this risk. Therefore, identifying strategies to bolster these personnel’s health and occupational performance is critical. Creatine monohydrate (CrM) supplementation may offer several benefits to firefighters and tactical athletes (e.g., police, security, and soldiers) due to its efficacy regarding physical performance, muscle, cardiovascular health, mental health, and cognitive performance. Methods: We conducted a narrative review of the literature with a focus on the benefits and application of creatine monohydrate among firefighters. Results: Recent evidence demonstrates that CrM can improve anaerobic exercise capacity and muscular fitness performance outcomes and aid in thermoregulation, decision-making, sleep, recovery from traumatic brain injuries (TBIs), and mental health. Emerging evidence also suggests that CrM may confer an antioxidant/anti-inflammatory effect, which may be particularly important for firefighters and those performing tactical occupations exposed to oxidative and physiological stress, which can elicit systemic inflammation and increase the risk of chronic diseases. Conclusions: This narrative review highlights the potential applications of CrM for related tactical occupations, with a particular focus on firefighters, and calls for further research into these populations.
Outpatient COVID-19 convalescent plasma recipient antibody thresholds correlated to reduced hospitalizations within a randomized trial
BACKGROUND COVID-19 convalescent plasma (CCP) virus-specific antibody levels that translate into recipient posttransfusion antibody levels sufficient to prevent disease progression are not defined. METHODS This secondary analysis correlated donor and recipient antibody levels to hospitalization risk among unvaccinated, seronegative CCP recipients within the outpatient, double-blind, randomized clinical trial that compared CCP to control plasma. The majority of COVID-19 CCP arm hospitalizations (15/17, 88%) occurred in this unvaccinated, seronegative subgroup. A functional cutoff to delineate recipient high versus low posttransfusion antibody levels was established by 2 methods: (i) analyzing virus neutralization–equivalent anti–Spike receptor-binding domain immunoglobulin G (anti-S-RBD IgG) responses in donors or (ii) receiver operating characteristic (ROC) curve analysis. RESULTS SARS-CoV-2 anti–S-RBD IgG antibody was volume diluted 21.3-fold into posttransfusion seronegative recipients from matched donor units. Virus-specific antibody delivered was approximately 1.2 mg. The high-antibody recipients transfused early (symptom onset within 5 days) had no hospitalizations. A CCP-recipient analysis for antibody thresholds correlated to reduced hospitalizations found a statistical significant association between early transfusion and high antibodies versus all other CCP recipients (or control plasma), with antibody cutoffs established by both methods-donor-based virus neutralization cutoffs in posttransfusion recipients (0/85 [0%] versus 15/276 [5.6%]; P = 0.03) or ROC-based cutoff (0/94 [0%] versus 15/267 [5.4%]; P = 0.01). CONCLUSION In unvaccinated, seronegative CCP recipients, early transfusion of plasma units in the upper 30% of study donors’ antibody levels reduced outpatient hospitalizations. High antibody level plasma units, given early, should be reserved for therapeutic use. TRIAL REGISTRATION ClinicalTrials.gov NCT04373460. FUNDING Department of Defense (W911QY2090012); Defense Health Agency; Bloomberg Philanthropies; the State of Maryland; NIH (3R01AI152078-01S1, U24TR001609-S3, 1K23HL151826NIH); the Mental Wellness Foundation; the Moriah Fund; Octapharma; the Healthnetwork Foundation; the Shear Family Foundation; the NorthShore Research Institute; and the Rice Foundation.
Sexual Medicine Society of North America (SMSNA)/American Urological Association (AUA) telemedicine and men’s health white paper
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.
(244) Participants with Penile Pain at Baseline May Benefit from Collagenase Clostridium Histolyticum Treatment: A Post Hoc Analysis
Abstract Introduction Peyronie’s disease (PD) is traditionally categorized into 2 phases: acute (active) and chronic (stable) phase; however, clinical definitions and distinction between the phases vary in the literature and remain blurred.[1] The American Urological Association guidelines outline changing symptoms with the presence of pain as a defining symptom of acute disease, but provide little guidance about timeframe.[2] Historically, acute-phase characteristics include presence of penile pain and progressing deformity (eg, worsening penile curvature), with time from symptom onset to acute phase completion being <3–18 months.[1] While there may be academic utility in temporally categorizing PD, it may limit or postpone the treatment options for patients suffering from the condition. Collagenase clostridium histolyticum (CCH) is an approved nonsurgical PD treatment option and several studies suggest its safety and efficacy in acute phase PD.[3-6] In light of these studies and ambiguity in dichotomizing phases, previous clinical trial data were reanalyzed to investigate the potential for opening the gamut of treatment options at earlier timepoints in the disease process. Objective This analysis examines CCH treatment efficacy on improving penile curvature in participants presenting with/without penile pain at baseline and disease duration of 12–18 months or >18 months from the CCH clinical trial program. Methods Literature related to CCH treatment of acute phase PD was compiled and treatment outcomes assessed. Additionally, a post hoc analysis of pooled data from two phase 3 randomized, double-blind trials of CCH in PD (IMPRESS I, NCT01221597; IMPRESS II, NCT01221623) was conducted. CCH-treated participants were stratified by the reporting of moderate-severe pain or no pain at baseline based on the following study measures: penile pain on palpation, penile pain on erection, PD questionnaire (PDQ) combined questions 7–9, and PDQ question 10 only. Additional subgroup analyses stratified participants by presence of pain and disease duration (12–18 or >18 months). The primary efficacy endpoint was the percentage change in penile curvature at week 52 from baseline. Results The IMPRESS I/II data analysis found that participants who experienced moderate-severe pain at baseline had penile curvature improvements by week 52 similar to participants with no pain at baseline. Across all pain measures, the percentage decreases in mean penile curvature from baseline ranged from 29%–42% for moderate-severe pain groups and 35%–37% for no penile pain groups. There were no clear differences in mean penile curvature improvement between groups for any specific pain measure when stratified by disease duration of 12–18 months (moderate-severe pain, 32%–40% improvement; no pain, 23%–29% improvement) versus >18 months (moderate-severe pain, 24%–44% improvement; no pain, 37%–40% improvement). Outcomes from the IMPRESS trials were comparable in context with published literature. Conclusions Based on a subanalysis of IMPRESS data, there were no clear differences identified in CCH treatment outcomes between participants experiencing moderate-severe pain or no pain at baseline regardless of disease duration (12–18 versus >18 months). These analyses are consistent with other literature evaluating the efficacy of CCH in the acute phase of disease and suggest that ongoing pain is not a contraindication to CCH therapy. Disclosure Yes, this is sponsored by industry/sponsor: Endo Pharmaceuticals Inc. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Endo Pharmaceuticals Inc; Boston Scientific Corporation; Antares Pharma, Inc; PathRight Medical.
Fully automated pipeline for white matter hyperintensity segmentation using clinical scans in patients with acute ischemic stroke (S19.001)