Khera, Mohit

Abstract Background To date, no scoring system has adequately defined clinical efficacy of erectile dysfunction (ED) therapies when evaluating differences between cohorts or in meta-analytic studies. Aim To outline the minimal criteria required for any therapy to be considered clinically effective in the treatment of ED. Methods An analytic review was performed of standardized ED questionnaires, with a particular emphasis placed on the International Index of Erectile Function, Erectile Function Domain (IIEF-EFD), and the minimally clinically important difference (MCID) concept. The data were used to create a societal position statement and recommendations on best practices within clinical trials to determine treatment efficacy. Outcomes The SMSNA provided 6 key statements and recommendations to suggest best practices and define minimal thresholds for improvements required for an ED therapy to be considered clinically effective. Results The IIEF-EFD currently represents the preferred standardized questionnaire to evaluate for changes in erectile function post-treatment and is the only questionnaire adequate to assess primary outcomes. To claim efficacy, investigational treatments must demonstrate MCID between cohorts (eg, 2-, 5-, or 7-point median improvements between groups among mild, moderate, or severe ED cohorts) in prospective, randomized, placebo-controlled, and adequately powered studies. In studies employing mixed-severity ED populations, a method of calculating an adjusted MCID was proposed based on statistical weighting principles. Similarly, a novel method for analyzing differences between cohorts in meta-analytic studies was presented to incorporate the concept of MCID. Based on these principles, the SMSNA would not support efficacy of a therapy based on statistical significance in a meta-analytic study alone. Similarly, studies claiming efficacy utilizing responder approaches (ie, statistically higher percentage of men achieving MCID between cohorts) would not be acceptable unless the median difference between groups on the IIEF-EFD achieved MCID. Clinical Implications The current position statement provides important, evidence-based data and scientific principles to help define what may be considered as an effective therapy in the treatment of ED. This framework provides a basis that decision-makers, clinicians, and patients may use to help differentiate clinically effective therapies. Strengths & Limitations The published literature is limited by a lack of validated instruments and data defining MCID for ED therapies between cohorts and with meta-analytic studies. The current position statement provides important guidance on these areas of ambiguity pending further, definitive data. Conclusion The current position statement provides detailed guidance on key criteria required to conclude efficacy of therapies used to treat ED.

Abstract Background Sexual Medicine Society of North America (SMSNA) fellowships offer variable experience in sexual health domains: erectile dysfunction, Peyronie’s disease, male infertility, male hypogonadism (low testosterone), reconstruction (including male incontinence), benign prostatic hyperplasia, gender affirmation surgery, sexual mental health, and female sexual dysfunction. Aim To evaluate baseline and postbootcamp understanding and trust in these domains. Methods In 2023, 28 of 31 urologists currently enrolled in SMSNA-endorsed fellowships participated in a 3.5-day training bootcamp in Minneapolis, Minnesota. Participants were asked to complete pre- and postbootcamp surveys. The bootcamp curriculum offered American Urological Association guidelines and case-based lectures, hands-on clinical training with cadavers (penile surgery) and models (collagenase training), and interaction with industry. Outcomes Changes in knowledge, independence, and trust in performing the procedures, as well as billing issues and feedback for future bootcamps. Results Prebootcamp surveys revealed vastly varied residency experience. Reported time with an expert faculty member was greatest for benign prostatic hyperplasia and least for female sexual dysfunction, gender affirmation surgery, and low testosterone. The lowest prebootcamp confidence in performing surgery independently was for penile grafting procedures and elevating the neurovascular bundle. Postbootcamp results revealed several areas of significant improvement in confidence (P ≤ .03): intralesional injections for Peyronie’s disease, manual modeling, penile plication, penile grafting procedures, and elevating the neurovascular bundle. There was a trend for improved confidence with the insertion of inflatable (P = .05) and semirigid (P = .08) penile prostheses. Nonsignificant improvement occurred in artificial urinary sphincter surgery (P = .12). Participants graded the bootcamp very highly and requested that next year’s bootcamp have more content on female sexual dysfunction, male incontinence, and low testosterone, as well as more hands-on skills sessions and case-based lecture formats. Clinical Implications Offering a bootcamp with hands-on instruction could significantly improve urologists’ knowledge and confidence. Strengths and Limitations As the main strength, this study was the first specialized bootcamp for urologists in the subject of men’s health, taking into account hands-on and cadaver laboratories, as well as highlighting industrial and pharmaceutical products. The small sample size was the major limitation. Conclusions Current SMSNA fellows present with varied levels of experience and confidence across sexual health domains. Notable confidence improvements were seen with topics that combined didactic lectures with hands-on trainings.

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 Introduction Penile Implant reservoir complications continue to drive surgical technique innovation to avoid catastrophic complication typically affiliated with theoretical placement in the space of Retzius. The high submuscular technique (versus initially described low submuscular) aimed to reduce migration/herniation. Most high submuscular technique complications are cosmetic, however, unintentional bowel injury and difficulty with extraction of these reservoirs has been reported. Furthermore, reservoirs left via drain and retain technique have been reported to cause significant bowel complications most typically when the reservoir or pressure regulating balloon unknowingly resides intraperitoneally. Objective We report outcomes of two surgeons who independently invented and published novel techniques allowing for low submuscular reservoir placement (and thus avoid blind puncture above the arcuate line) to help avoid reservoir complications. Methods Two surgeons’ technique outcomes were assessed. The first surgical technique (T1) involves suturing an additional implant connector collar to the pubic bone with a permanent stitch. This collar acts as a backstop to prevent reservoir herniation or migration into the scrotum. It can also be used to prevent upward migration of drain and retain reservoirs as the retained reservoir is capped. The second surgical technique (T2) involves placing a right angle outside in of the fascia after a pocket is cleared below the muscle and pulling the implant tubing through this defect. This approach stops the prb or reservoir at the puncture site. Results T1 was performed 55 times for reservoir fixation and 7 times for drain and retain fixation. Mean follow up is 11 months. One infection occurred necessitating reservoir removal (and cutting of permanent stitch) which was easily accomplished. No other complications or patient complaints from this technique have occurred. Average case time increase is 5-10 minutes. T2 has been performed 31 times for reservoir fixation with no complications or patient complaints. Average case time increase is < 5 minutes. Conclusions Although submuscular reservoir techniques decrease catastrophic complications and are widely adopted, they are not without risk. We report success of two independent techniques that demonstrate safety and feasibility with low reservoir placement. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Mayo Clinic – Rochester

Abstract Introduction Inflatable penile prosthesis reservoir herniation or migration may occur with space of Retzius or submuscular placement. The dangers of high submuscular placement include bowel or bladder perforation (from blind instrument passage) and or bowel herniation (from unintentional peritoneal placement and stretching of small opening with reservoir filling). Even under direct vision submuscular placement, reservoirs can ultimately reside into the scrotum, retroperitoneum, and lateral abdominal wall. The Transfascial Fixation (TFF) technique was recently developed to prevent reservoir migration with placement either submuscularly or in the space of Retzius, but video of this technique has not been previously published. Objective To visually demonstrate the proper surgical technique of TFF during IPP reservoir placement. Methods An IPP surgical candidate at high risk of complications should reservoir migration occur was identified. Video of TFF technique performed during IPP surgery was recorded using an in-light overhead camera and a GoPro aseptically positioned on the lead surgeon. Results Successful demonstration of TFF technique during IPP placement. Conclusions TFF technique is a feasible option to aid prevention of penile implant reservoir herniation. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Boston Scientific, Metuchen Pharmaceuticals, Acerus Pharmaceuticals, Endo Pharmaceuticals, AbbVie Inc.

Abstract Introduction Peyronie’s disease (PD) is a connective tissue disorder associated with the formation of fibrotic plaques in the tunica albuginea, leading to penile curvature. PD is underdiagnosed, and this may be related to the reluctance of some men to seek consultation with a health care provider (HCP). Objective The aim was to develop an English-language digital application (app) to increase PD awareness, give men concerned about penile curvature a self-screening tool, and provide a link for locating HCPs with expertise in PD. Methods The Peyronie’s Disease Self-Assessment App is Android- and iOS-compatible. It was developed as a self-assessment tool for screening purposes only. It is not intended to diagnose, treat, cure, or prevent any medical condition, disease, or health problem and should not be considered a replacement for a consultation with a physician. The app provides instructional videos on general features and how to perform a penile scanning procedure. Results The PD Self-Assessment App includes a questionnaire related to penile curvature, penetration difficulty, degree of bother for partner, and impact on sexual activity. An innovative feature of the app is a live scanning technology, which uses the phone’s camera to detect the contours of the penis from multiple angles and applies an algorithm that determines the degree of curvature. The resulting image is a 3D penile simulation in the app, which allows the user to mark the location of any “lumps.” The app will also produce a 2D outline to determine the maximum curvature. External links are provided to a PD education website and to locate an HCP. The patient can share both the questionnaire responses and penile curvature simulation with his HCP via the user’s native email. This tool has password protection features and encrypts sensitive data. The scan images are representations of the penis, not photographs. Images are stored in the app library and are not stored in the user’s photo gallery. To enhance security, all data are erased when the app is uninstalled. The app is adaptable and scalable as needed for future updates. Conclusions The PD Self-Assessment App will help improve patient knowledge of the condition, document penile deformity, and facilitate consultation with an HCP. For men with PD, the app will help ease their journey with PD. The app will assist HCPs with evaluation and diagnosis. Sequential documentation of penile curvature during medical treatment, during mechanical traction protocols, or following surgery will provide an evidence basis for tracking long-term outcomes in PD. 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.

AbstractBackgroundMale hypogonadism (testosterone level < 300 ng/dl) is a clinical syndrome that results from failure of the testis to produce physiological levels of testosterone. Most marketed testosterone replacement therapy products often require multiple dose adjustment clinic visits to achieve the desired, eugonadal testosterone levels.ObjectiveTo evaluate the efficacy and safety of a novel oral testosterone undecanoate therapy for the treatment of hypogonadism.Material and methodsNinety‐five (N = 95) hypogonadal men were enrolled in this open‐label, single‐arm, multicenter study in the United States (NCT03242590). Subjects received 225 mg of oral testosterone undecanoate (TLANDO) twice a day for 24 days without dose adjustment. Primary efficacy was percentages of subjects who achieved mean 24‐h testosterone levels within the eugonadal range and secondary efficacies were evaluated based on the upper limit of lab normal range of testosterone concentration.ResultsSubjects enrolled were on average age of 56 years, with about 17% of subjects older than 65 years. The mean body mass index was 32.8 kg/m2. The baseline mean total testosterone values were below the normal range (202 ± 74 ng/dl). Post‐treatment with 450 mg testosterone undecanoate daily dose without dose adjustment, 80% of subjects (95% confidence interval of 72%–88%) achieved a testosterone Cavg in the normal range and restored testosterone levels to mean testosterone Cavg of 476 ± 184 ng/dl at steady state. Testosterone restoration was comparable to other approved testosterone replacement therapy products. TLANDO was well tolerated with no deaths, no drug‐related serious adverse events, and no hepatic adverse events.Discussion and conclusionsTLANDO restored testosterone levels to the normal range in the majority of hypogonadal males. This new oral testosterone replacement therapy can provide an option for no‐titration oral testosterone replacement therapy. This therapy has the potential to improve patient compliance in testosterone replacement therapy.