Mulhall, John P.

Abstract Introduction Penile implant (PI) surgery is a well-recognized strategy for erectile dysfunction (ED) with excellent functional/satisfaction outcomes. To date, little attention has been paid to the attitudes and satisfaction outcomes of female partners of such patients. Objective To qualitatively assess how female partners feel about PI surgery to inform the development of a female partner specific questionnaire. Methods Female partners of men who had undergone PI surgery (3-piece inflatable) underwent concept elicitation interviews. Prior to this, a panel of experts in female sexual health and PI surgery was convened to define potential domains of interest. Women were interviewed by one of two female sexual medicine clinicians to elicit concepts. As part of the spontaneous item generation phase, participants were asked about their attitudes, hopes and concerns prior to PI surgery, as well as changes in partner post-surgery. Participants were then asked whether they identified domains raised by the expert panel that were not mentioned during the spontaneous phase. Additional open-ended questions were asked about experiences before and after PI surgery. Interviews were transcribed verbatim for subsequent qualitative analysis by 2 trained members of the study team. Results 12 women have been interviewed. Mean partner age = 60 years, relationship duration = 20 years. Interviews were held <12 months post-PI for 17% of partners, 12-24 months for 25%, >24 months for 58%. Partner communication and involvement in decision to get the implant were uniquely raised as pre-surgical concerns, whereas PI attributes were uniquely mentioned as post-surgical concerns. How the PI has impacted the man’s self-esteem, whether impacts to self-esteem have affected the partner, and overall satisfaction with sex were most common concepts raised across pre- and post-surgery (See Table). Conclusions Using rigorous qualitative methodology, we have identified concepts that are unique to pre-surgery, post-surgery, and common across the surgical experience among partners of men who have undergone penile implant surgery. These data will facilitate development of a tool to assess female partner attitudes, beliefs and satisfaction prior to and after PI surgery. Disclosure No

AbstractIntroductionPrior consensus meetings have addressed the relationship between phosphodiesterase type 5 (PDE5) inhibition and cardiac health. Given significant accumulation of new data in the past decade, a fourth consensus conference on this topic was convened in Pasadena, California, on March 10 and 11, 2023.ObjectivesOur meeting aimed to update existing knowledge, assess current guidelines, and make recommendations for future research and practice in this area.MethodsAn expert panel reviewed existing research and clinical practice guidelines.ResultsKey findings and clinical recommendations are the following: First, erectile dysfunction (ED) is a risk marker and enhancer for cardiovascular (CV) disease. For men with ED and intermediate levels of CV risk, coronary artery calcium (CAC) computed tomography should be considered in addition to previous management algorithms. Second, sexual activity is generally safe for men with ED, although stress testing should still be considered for men with reduced exercise tolerance or ischemia. Third, the safety of PDE5 inhibitor use with concomitant medications was reviewed in depth, particularly concomitant use with nitrates or alpha-blockers. With rare exceptions, PDE5 inhibitors can be safely used in men being treated for hypertension, lower urinary tract symptoms and other common male disorders. Fourth, for men unresponsive to oral therapy or with absolute contraindications for PDE5 inhibitor administration, multiple treatment options can be selected. These were reviewed in depth with clinical recommendations. Fifth, evidence from retrospective studies points strongly toward cardioprotective effects of chronic PDE5-inhibitor use in men. Decreased rates of adverse cardiac outcomes in men taking PDE-5 inhibitors has been consistently reported from multiple studies. Sixth, recommendations were made regarding over-the-counter access and potential risks of dietary supplement adulteration. Seventh, although limited data exist in women, PDE5 inhibitors are generally safe and are being tested for use in multiple new indications.ConclusionStudies support the overall cardiovascular safety of the PDE5 inhibitors. New indications and applications were reviewed in depth.

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 An iteration of artificial intelligence (AI), large language models (LLMs), such as ChatGPT, have recently gained popularity as a potential educational resource for patients, students, and researchers. LLMs utilize deep learning algorithms to predict the next word in a sequence based on a data library of 300 billion words. Recent studies have shown that while LLMs provide useful information, they are limited due to producing false and nonsensical information. A focus of studies has been on the utility of ChatGPT as an educational resource to patients and learners; however, no study has investigated the utilization of ChatGPT to write a scientific review. AI- generated systematic reviews would be valuable to the dynamic field of urology, especially in terms of research and innovation. Objective Considering the limitations of ChatGPT in performing data analysis, the aim of this project was to assess the utility of AI in constructing introductions of a systematic review on urologic issues and to compare these AI-generated introductions to published introductions written by humans. Methods ChatGPT (4.0), available at www.chat.openai.com, was used to construct three introductions to three different systematic reviews on the following topics: testosterone therapy and cardiovascular events, safety and efficacy of noninvasive therapies for Peyronie’s disease, and erectile dysfunction after radical prostatectomy. Introductions from published systematic reviews in each of the above topics were also obtained. Five different experts in these topics, who were blinded to which introductions were AI generated, reviewed then assessed the introductions for the following parameters: completeness, engagement, accuracy, logic, and clarity of objective. Introductions were assessed for baseline literary differences as well. Results There were no significant differences in the words, characters, number of sentences, and length of sentences between AI-generated introductions compared to those written by humans. There was a statistically significant difference in word length, with AI having a lower average of word length. AI scored significantly higher on average in the categories of completeness and engagement. We did not observe a significant difference between the two groups in the other categories. These observed findings demonstrate that AI can synthesize urologic literature (sexual medicine/men’s health) and generate introductions of a systematic review that are minimally noninferior and possibly superior regarding engagement and completeness. The limitations from this study include a small sample size (5) and the exclusive focus on AI-generated introductions rather than other AI-generated sections of a systematic review. Conclusions Our study reveals that ChatGPT, as an LLM, can provide a noninferior, possibly superior, introduction to a systematic review on topics of urologic sexual medicine and men’s health. As more facets of AI are developed, such as data integration and analysis, AI could be used to generate entire systematic reviews noninferior to those written by humans. Ethical principles of using AI in scientific literature should be examined and discussed prior to the development of more enhanced LLMs. Disclosure No.

Abstract Background In 1999, 1 year after the approval of the first oral phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED), the first Princeton Consensus Conference was held to address the clinical management of men with ED who also had cardiovascular disease. These issues were readdressed in the second and third conferences. In the 13 years since the last Princeton Consensus Conference, the experience with PDE5 inhibitors is more robust, and recent new data have emerged regarding not only safety and drug–drug interactions, but also a potential cardioprotective effect of these drugs. Aim In March 2023, an interdisciplinary group of scientists and practitioners met for the fourth Princeton Consensus Guidelines at the Huntington Medical Research Institutes in Pasadena, California, to readdress the cardiovascular workup of men presenting with ED as well as the approach to treatment of ED in men with known cardiovascular disease. Method A series of lectures from experts in the field followed by Delphi-type discussions were developed to reach consensus. Outcomes Consensus was reached regarding a number of issues related to erectile dysfunction and the interaction with cardiovascular health and phosphodiesterase-5 inhibitors. Results An algorithm based on recent recommendations of the American College of Cardiology and American Heart Association, including the use of computed tomography coronary artery calcium scoring, was integrated into the evaluation of men presenting with ED. Additionally, the issue of nitrate use was further considered in an algorithm regarding the treatment of ED patients with coronary artery disease. Other topics included the psychological effect of ED and the benefits of treating it; the mechanism of action of the PDE5 inhibitors; drug–drug interactions; optimizing use of a PDE5 inhibitors; rare adverse events; potential cardiovascular benefits observed in recent retrospective studies; adulteration of dietary supplements with PDE5 inhibitors; the pros and cons of over-the-counter PDE5 inhibitors; non–PDE5 inhibitor therapy for ED including restorative therapies such as stem cells, platelet-rich plasma, and shock therapy; other non–PDE5 inhibitor therapies, including injection therapy and penile prostheses; the issue of safety and effectiveness of PDE5 inhibitors in women; and recommendations for future studies in the field of sexual dysfunction and PDE5 inhibitor use were discussed. Clinical Implications Algorithms and tables were developed to help guide the clinician in dealing with the interaction of ED and cardiovascular risk and disease. Strengths and Limitations Strengths include the expertise of the participants and consensus recommendations. Limitations included that participants were from the United States only for this particular meeting. Conclusion The issue of the intersection between cardiovascular health and sexual health remains an important topic with new studies suggesting the cardiovascular safety of PDE5 inhibitors.

AbstractBackgroundPatients with prostate cancer suffer significant sexual dysfunction after treatment which negatively affects them and their partners psychologically, and strain their relationships.AimWe convened an international panel with the aim of developing guidelines that will inform clinicians, patients and partners about the impact of prostate cancer therapies (PCT) on patients’ and partners’ sexual health, their relationships, and about biopsychosocial rehabilitation in prostate cancer (PC) survivorship.MethodsThe guidelines panel included international expert researchers and clinicians, and a guideline methodologist. A systematic review of the literature, using the Ovid MEDLINE, Scopus, CINAHL, PsychINFO, LGBT Life, and Embase databases was conducted (1995–2022) according to the Cochrane Handbook for Systematic Reviews of Interventions. Study selection was based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Each statement was assigned an evidence strength (A-C) and a recommendation level (strong, moderate, conditional) based on benefit/risk assessment, according to the nomenclature of the American Urological Association (AUA). Data synthesis included meta-analyses of studies deemed of sufficient quality (3), using A Measurement Tool to Assess Systematic Reviews (AMSTAR).OutcomesGuidelines for sexual health care for patients with prostate cancer were developed, based on available evidence and the expertise of the international panel.ResultsThe guidelines account for patients’ cultural, ethnic, and racial diversity. They attend to the unique needs of individuals with diverse sexual orientations and gender identities. The guidelines are based on literature review, a theoretical model of sexual recovery after PCT, and 6 principles that promote clinician-initiated discussion of realistic expectations of sexual outcomes and mitigation of sexual side-effects through biopsychosocial rehabilitation. Forty-seven statements address the psychosexual, relationship, and functional domains in addition to statements on lifestyle modification, assessment, provider education, and systemic challenges to providing sexual health care in PC survivorship.Clinical ImplicationsThe guidelines provide clinicians with a comprehensive approach to sexual health care for patients with prostate cancer.Strengths & LimitationsThe strength of the study is the comprehensive evaluation of existing evidence on sexual dysfunction and rehabilitation in prostate cancer that can, along with available expert knowledge, best undergird clinical practice. Limitation is the variation in the evidence supporting interventions and the lack of research on issues facing patients with prostate cancer in low and middle-income countries.ConclusionThe guidelines document the distressing sexual sequelae of PCT, provide evidence-based recommendations for sexual rehabilitation and outline areas for future research.

ABSTRACT Introduction Despite an increasing number of publications on Peyronie's disease (PD), evidence-based clinical decision making remains challenging due to the small number of well-designed clinical trials. The quality of available PD literature has not been assessed to date. Objective We sought to evaluate the quality of the methodology and reporting of systematic reviews and meta-analyses in PD literature Methods Study protocol registration was performed on the Open Science Framework platform. In January 2021, a systematic electronic search of the Medline/PubMed, Embase, Ovid, Scopus, Joanne Briggs Institute and Cochrane databases was performed. Search terms included “Peyronie's disease” and “systematic review OR meta-analysis OR meta analysis”. Eligibility criteria were relevance to Peyronie's disease and specification of “systematic review” or “meta-analysis” in the title or abstract. A database was created to summarize the relevant methodological and reporting criteria for each article. The outcomes included review type, authorship, journal, publication date, “A MeaSurement Tool to Assess systematic Reviews” (AMSTAR-2) score and “Preferred Reporting Items for Systematic Reviews and Meta-Analyses” (PRISMA) score. Risk of bias was assessed using the ROBIS tool. Data were tabulated and reported as means with standard deviation, median with interquartile range (IQR) and t-testing as appropriate. Strength of association between variables was calculated using the Pearson correlation coefficient. Statistical analyses were performed on RStudio (version 1.4.1106). Results From 1974 to 2021, 340 articles were identified. After review 23 full length articles were included. Seventeen were systematic reviews, 4 meta-analyses and 2 were combined. Twenty-one (87.5%) articles were published after the year 2009 when the PRISMA guidelines were published. There was median 53.8% (IQR 38.2%) adherence to AMSTAR-2 criteria and 66.7% (IQR 38.9%) adherence to PRISMA criteria. The overall AMSTAR confidence rating was Critically Low in 15/23 studies, indicating more than one critical flaw. Correlation analysis revealed very high positive association between AMSTAR 2 and PRISMA adherence (+0.97). ROBIS revealed “High” concern regarding methods used to collect data and appraise 17/23 studies (73.9%), and “High” concern regarding synthesis and findings in 14/23 studies (60.9%). Conclusions Transparent reporting of methodology and findings in SRs and MAs is crucial to maintaining research integrity and allowing for accurate interpretation of results. Despite an increasing number of publications in PD, many of these studies fail to meet accepted methodological criteria for reporting. More high quality randomized controlled trials in PD are necessary; while systematic reviews and meta-analyses should focus on these high-quality studies with uniform use of accepted reporting guidelines. Disclosure No