Cosmetic penile enhancement procedures: an SMSNA position statement.

BACKGROUND: Penile cosmetic enhancement procedures have been performed for many years with varying success. However, they have historically been relegated to niche areas of sexual medicine, with limited data, and have not achieved mainstream adoption. More recently, the topic has been increasingly discussed within academic congresses due to availability of novel techniques, therapies, and procedures. Given their distinctive nature, the Sexual Medicine Society of North America (SMSNA) felt that it was pertinent to develop formal position statements to help guide both patients and sexual medicine providers on the current state of the scientific literature and to give recommendations for future research. AIM: The study sought to provide an evidence-based set of recommendations for injection and surgical procedures designed to lengthen, augment, or otherwise cosmetically enhance the penis. METHODS: A review was performed of all scientific literature listed in PubMed from inception through December 2023 relating to penile cosmetic enhancement procedures. Only invasive (injection/surgery) therapies were included due to their distinct risk-benefit profile compared with more conservative treatments (eg, vacuum erection devices, penile traction devices). Similar therapies were categorized, with pertinent data summarized and used to help create relevant position statements. All statements were expert opinion only and were based on analyses of the potential risks and benefits of the specific therapies. OUTCOMES: A total of 6 position statements were issued relating to 5 distinct sexual medicine cosmetic enhancement procedures. RESULTS: A consensus opinion was reached by SMSNA leadership on the state of injection/surgical penile cosmetic enhancement procedures as of 2024. Key topic areas addressed included injectable soft tissue fillers, suspensory ligament division, graft-and-flap procedures, silicone sleeve implants, and sliding/slicing techniques. Distinct recommendations were tailored to each therapy and were based solely on the current state of the literature. It is anticipated that future studies will further inform position statements and will lead to ongoing modifications. CLINICAL IMPLICATIONS: The current position statements provide both patients and clinicians evidence-based, expert recommendations on best practices relating to penile cosmetic enhancement procedures. STRENGTHS AND LIMITATIONS: Strengths include the use of an expert panel of sexual medicine clinicians, consensus design, and summary of existing literature. Limitations include expert opinion and limited research on the topic. CONCLUSION: The current SMSNA position statements provide evidence-based, consensus opinions on the appropriate role for penile augmentation and cosmetic procedures in 2024.

Sexual Medicine Society of North America (SMSNA)/American Urological Association (AUA) telemedicine and men's health white paper.

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.

Optimizing sexual reproductive health of men and women with cystic fibrosis: A systematic review.

This systematic review summarizes the impact of cystic fibrosis (CF) on sexual and reproductive health (SRH) in males and females, covering pubertal development, hormonal function, family planning, and fertility. Included articles featured historical CF diagnostic criteria, preclinical or clinical data (retrospective cohorts or open label trials), while excluded articles lacked full text availability, explicit methodology, or comparisons between CF and non-CF patients. Genotype differences in CFTR mutations influenced symptom severity. Males with CF experienced delayed puberty, hypogonadism, infertility from obstructive azoospermia, and semen parameter issues. Female CF patients showed decreased fertility, possibly linked to disrupted ionic balance and ovarian cystic disease. Assistive reproductive technologies addressed fertility issues, but success varied based on disease severity and genotype. CFTR modulators aided pulmonary function and sexual health but require further assessment for fertility benefits.

Androgen deprivation therapy for prostate cancer and neurocognitive disorders: a systematic review and meta-analysis.

BACKGROUND: Prostate cancer is a prevalent disease that urgently needs to address its treatment-related complications. By examining existing evidence on the association between Androgen Deprivation Therapy (ADT) and dementia, this study contributes to the understanding of potential risks. We sought to analyze the currently available evidence regarding the risk of dementia, Alzheimer's disease (AD), vascular dementia, and Parkinson's disease (PD) in patients undergoing ADT. METHODS: A systematic search of PubMed, EMBASE, Scopus, and Google Scholar was performed to identify studies published from the databases' inception to April 2023. Studies were identified through systematic review to facilitate comparisons between studies with and without some degree of controls for biases affecting distinctions between ADT receivers and non-ADT receivers. This review identified 305 studies, with 28 meeting the inclusion criteria. Heterogeneity was assessed using Higgins I2%. Variables with an I2 over 50% were considered heterogeneous and analyzed using a Random-Effects model. Otherwise, a Fixed-Effects model was employed. RESULTS: A total of 28 studies were included for analysis. Out of these, only 1 study did not report the number of patients. From the remaining 27 studies, there were a total of 2,543,483 patients, including 900,994 with prostate cancer who received ADT, 1,262,905 with prostate cancer who did not receive ADT, and 334,682 patients without prostate cancer who did not receive ADT. This analysis revealed significantly increased Hazard Ratios (HR) of 1.20 [1.11, 1.29], p < 0.00001 for dementia, HR 1.26 [1.10, 1.43], p = 0.0007 for Alzheimer's Disease, HR 1.66 [1.40, 1.97], p < 0.00001 for depression, and HR 1.57 [1.31, 1.88], p < 0.00001 for Parkinson's Disease. The risk of vascular dementia was HR 1.30 [0.97, 1.73], p < 0.00001. CONCLUSION: Based on the analysis of the currently available evidence, it suggests that ADT significantly increases the risk of dementia, AD, PD, and depression.

Effect of Testosterone Replacement Therapy on Sexual Function and Hypogonadal Symptoms in Men with Hypogonadism.

CONTEXT: Few long-term randomized trials have evaluated the efficacy of testosterone replacement therapy (TRT) in improving sexual function and hypogonadal symptoms in men with hypogonadism and whether effects are sustained beyond 12 months. OBJECTIVE: The Testosterone Replacement therapy for Assessment of long-term Vascular Events and efficacy ResponSE in hypogonadal men (TRAVERSE) study evaluated the effect of TRT on major adverse cardiovascular events in middle-aged and older men with hypogonadism. The Sexual Function Study, nested within the parent trial, determined testosterone's efficacy in improving sexual activity, hypogonadal symptoms, libido, and erectile function among men reporting low libido. METHODS: Among 5204 men, 45-80 years, with 2 testosterone concentrations <300 ng/dL, hypogonadal symptoms, and cardiovascular disease (CVD) or increased CVD risk enrolled in the TRAVERSE trial, 1161 with low libido were enrolled in the Sexual Function Study (587 randomized to receive 1.62% testosterone gel and 574 to placebo gel for the duration of their participation in the study). Primary outcome was change from baseline in sexual activity score. Secondary outcomes included hypogonadal symptoms, erectile function, and sexual desire. RESULTS: TRT was associated with significantly greater improvement in sexual activity than placebo (estimated mean [95% CI] between-group difference 0.49 [0.19,0.79] and 0.47 [0.11, 0.83] acts per day at 6 and 12 months, respectively; omnibus test P = .011); treatment effect was maintained at 24 months. TRT improved hypogonadal symptoms and sexual desire, but not erectile function, compared with placebo. CONCLUSION: In middle-aged and older men with hypogonadism and low libido, TRT for 2 years improved sexual activity, hypogonadal symptoms, and sexual desire, but not erectile function.

Will you go the distance? A satisfaction survey of telemedicine in sexual medicine.

Background: The success of telemedicine depends on patient satisfaction with the care that they receive, which is impacted by the ease of use of the technology, quality of the connection, and perceived effectiveness of care. Aim: The study sought to evaluate patient satisfaction with telemedicine services in a high-volume andrology clinic. Methods: We included all patients who had a telemedicine appointment between January 1, 2020, and August 22, 2022. Demographic information was gathered, and a satisfaction survey was conducted using REDCap software. Data were grouped into 2 age categories, with ≥50 years as the cutoff (19-50 years; >50 years). The data were analyzed according to age, distance from the patient's home to our center, and survey responses. Pearson's chi-square test and ordinal logistic regression analyses were performed. Outcomes: The main outcome is satisfaction with telemedicine in a men's sexual health context. Results: A total of 4071 patients were identified based on attending a telemedicine visit. Hypogonadism was the most common diagnosis. Other diagnoses included erectile dysfunction, varicocele, Peyronie's disease, vasectomy, and infertility. In total, 613 patients completed the survey, with a mean age of 56.6 years. Older patients were less likely to prefer telemedicine (odds ratio [OR], 0.55; 95% confidence interval [CI], 0.36-0.80; P < .001), less likely to agree to a video visit because of privacy concerns (OR, 0.51; 95% CI, 0.35-0.75; P < .001), and less likely to recommend a telemedicine visit compared with their younger counterparts (OR, 0.37; 95% CI, 0.27-0.51; P < .001). The median distance was 22.4 (interquartile range, 7.5-57.5) miles. However, there was no significant association between distance and patients' likelihood of preferring telehealth visits, including reviews of outside laboratories and imaging (OR, 1; 95% CI, 0.99-1; P = .35), belief in the quality of care provided via video visits (OR, 0.99, CI 0.99-1; P = .25), and overall preference for telehealth visits (OR, 0.99; 95% CI, 0.99-1; P = .35). Clinical Implications: Healthcare providers should consider the age of patients when deciding to offer telemedicine while addressing privacy concerns to provide adequate reassurance to patients who may have concerns about the quality of care provided through telemedicine. Strengths and Limitations: Our study achieved a substantial sample size that reached statistical significance. Conducted at a single academic center, our study was constrained, possibly introducing biases related to the institution's advanced telemedicine system. Geographic and diagnostic limitations could lead to regional biases, affecting the generalizability of the findings. Conclusion: Older patients exhibited a lower inclination toward preferring telemedicine, along with decreased odds of endorsing in-person visits.

Prostate Safety Events During Testosterone Replacement Therapy in Men With Hypogonadism: A Randomized Clinical Trial.

Importance: The effect of testosterone replacement therapy (TRT) on the risk of prostate cancer and other adverse prostate events is unknown. Objective: To compare the effect of TRT vs placebo on the incidences of high-grade prostate cancers (Gleason score ≥4 + 3), any prostate cancer, acute urinary retention, invasive prostate procedures, and pharmacologic treatment for lower urinary tract symptoms in men with hypogonadism. Design, Setting, and Participants: This placebo-controlled, double-blind randomized clinical trial enrolled 5246 men (aged 45-80 years) from 316 US trial sites who had 2 testosterone concentrations less than 300 ng/dL, hypogonadal symptoms, and cardiovascular disease (CVD) or increased CVD risk. Men with prostate-specific antigen (PSA) concentrations greater than 3.0 ng/mL and International Prostate Symptom Score (IPSS) greater than 19 were excluded. Enrollment took place between May 23, 2018, and February 1, 2022, and end-of-study visits were conducted between May 31, 2022, and January 19, 2023. Intervention: Participants were randomized, with stratification for prior CVD, to topical 1.62% testosterone gel or placebo. Main Outcomes and Measures: The primary prostate safety end point was the incidence of adjudicated high-grade prostate cancer. Secondary end points included incidence of any adjudicated prostate cancer, acute urinary retention, invasive prostate surgical procedure, prostate biopsy, and new pharmacologic treatment. Intervention effect was analyzed using a discrete-time proportional hazards model. Results: A total of 5204 men (mean [SD] age, 63.3 [7.9] years) were analyzed. At baseline, the mean (SD) PSA concentration was 0.92 (0.67) ng/mL, and the mean (SD) IPSS was 7.1 (5.6). The mean (SD) treatment duration as 21.8 (14.2) months in the TRT group and 21.6 (14.0) months in the placebo group. During 14 304 person-years of follow-up, the incidence of high-grade prostate cancer (5 of 2596 [0.19%] in the TRT group vs 3 of 2602 [0.12%] in the placebo group; hazard ratio, 1.62; 95% CI, 0.39-6.77; P = .51) did not differ significantly between groups; the incidences of any prostate cancer, acute urinary retention, invasive surgical procedures, prostate biopsy, and new pharmacologic treatment also did not differ significantly. Change in IPSS did not differ between groups. The PSA concentrations increased more in testosterone-treated than placebo-treated men. Conclusions and Relevance: In a population of middle-aged and older men with hypogonadism, carefully evaluated to exclude those at high risk of prostate cancer, the incidences of high-grade or any prostate cancer and other prostate events were low and did not differ significantly between testosterone- and placebo-treated men. The study's findings may facilitate a more informed appraisal of the potential risks of TRT. Trial Registration: ClinicalTrials.gov Identifier: NCT03518034.

Hyperbaric oxygen therapy as a treatment for erectile dysfunction: a meta-analysis.

INTRODUCTION: Hyperbaric oxygen therapy (HBOT) is a medical treatment in which the patient is exposed to 100% oxygen at a higher than atmospheric pressure. Over the past few decades, HBOT has been used to treat a variety of medical conditions. In recent times, there has been a rising curiosity regarding the potential therapeutic benefits of HBOT in the treatment of erectile dysfunction (ED). AIMS: The study sought to review and meta-analyze available data regarding the use of HBOT for ED, including its potential mechanisms of action and effectiveness. METHODS: We included only articles that evaluated the impact of HBOT on ED symptoms using the International Index of Erectile Function score. Prospective nonrandomized studies or randomized controlled clinical trials were included. Data extraction was performed in duplicate. Data analysis was conducted using Review Manager 5.41, and the presence of heterogeneity between studies was evaluated. The results were presented as the mean difference (MD) with 95% confidence interval (CI). RESULTS: A total of 5 studies that reported outcomes using the International Index of Erectile Function scores were included in this analysis. In patients with post-robotic-assisted laparoscopic prostatectomy-induced ED, the analysis showed a significant MD of -4.13 (95% CI, -6.08 to -2.18; P < .0001) in favor of the control group. Conversely, patients who received HBOT for reasons other than ED exhibited an MD of 4.58 (95% CI, 2.63 to 6.52; P < .00001). In the group that received HBOT for pure vasculogenic ED, the MD was 10.50 (95% CI, 9.92 to 11.08) in favor of HBOT. A meta-analysis of these data revealed a nonsignificant difference in erectile function scores, with an MD of 3.86 (95% CI, -2.13 to 9.86; P = .21). CONCLUSION: The use of HBOT in the treatment of ED appears to be a promising approach. While further research is needed to establish the efficacy and long-term effects of this treatment, preliminary studies have shown encouraging results in terms of improving erectile function in men with vasculogenic ED.

Effect of aerobic exercise on erectile function: systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: The health benefits of regular aerobic exercise are well established, although there is limited high-quality evidence regarding its impact on erectile function. AIM: To determine the effect of aerobic exercise on erectile function in men and to identify factors that may influence this effect. METHODS: This systematic review and meta-analysis included randomized controlled trials that evaluated the effects of aerobic exercise on erectile function via the Erectile Function domain of the International Index of Erectile Function (IIEF-EF). The mean difference in IIEF-EF scores between the aerobic exercise and nonexercising control groups was estimated by a random-effects meta-analysis. Meta-regression was used to evaluate the association of moderator variables on meta-analysis results. OUTCOMES: The IIEF-EF score is reported on a 6-30 scale, with higher values indicating better erectile function. RESULTS: Among 11 randomized controlled trials included in the analysis, aerobic exercise resulted in statistically significant improvements in IIEF-EF scores as compared with controls, with a mean difference of 2.8 points (95% CI, 1.7-3.9; P < .001) and moderate heterogeneity among studies (I2 = 53%). The effect of aerobic exercise on erectile function was greater in men with lower baseline IIEF-EF scores, with improvements of 2.3, 3.3, and 4.9 points for mild, moderate, and severe erectile dysfunction, respectively (P = .02). The meta-analysis results were not influenced by publication bias or individual study effects. CLINICAL IMPLICATIONS: Health care providers should consider recommending regular aerobic exercise as a low-risk nonpharmacologic therapy for men experiencing erectile difficulties. STRENGTHS AND LIMITATIONS: The primary strength of this review was the generation of level 1 evidence on a topic of general interest regarding sexual health in men. However, the included studies evaluated diverse groups, which may complicate data interpretation for specific segments of the population. CONCLUSION: Regular aerobic exercise can improve the erectile function of men, particularly those with lower baseline IIEF-EF scores.

Stem cell therapy for erectile dysfunction: a systematic review.

INTRODUCTION: Erectile dysfunction (ED) is a common condition that negatively affects men's quality of life. It can have various causes, including psychological, vascular, and neurologic factors. Existing treatments for ED mainly focus on symptom relief rather than addressing the underlying cause. Stem cells (SCs) have shown potential as a therapeutic approach for ED due to their anti-inflammatory properties. OBJECTIVES: This systematic review aims to assess the current status of trials and determine the potential impact of SCs on male sexual health. METHODS: A comprehensive search strategy was employed to gather relevant articles from 6 electronic databases. The search included articles published until March 2023. The reference lists of articles were manually reviewed to identify additional studies of relevance. The eligibility criteria for inclusion in the analysis focused on clinical trials involving humans that evaluated the safety and efficacy of SC therapy for ED. Exclusion criteria encompassed case reports, case series, abstracts, reviews, and editorials, as well as studies involving animals or SC derivatives. Data extraction was performed via a standardized form with a focus on erectile outcomes. RESULTS: A total of 2847 articles were initially identified; 18 were included in the final analysis. These studies involved 373 patients with ED and various underlying medical conditions. Multiple types of SC were utilized in the treatment of ED: mesenchymal SCs, placental matrix-derived mesenchymal SCs, mesenchymal SC-derived exosomes, adipose-derived SCs, bone marrow-derived mononuclear SCs, and umbilical cord blood SCs. CONCLUSION: SC therapy shows promise as an innovative and safe treatment for organic ED. However, the lack of standardized techniques and controlled groups in many studies hampers the ability to evaluate and compare trials.

Implantable Penile Prosthesis for Erectile Dysfunction: Insurance Coverage in the United States.

INTRODUCTION: A manufacturer's benefit verification database was evaluated to ascertain United States health plan insurance coverage for implantable penile prostheses for erectile dysfunction. METHODS: All-payer and employer-sponsored health plan benefit verification databases were queried to determine implantable penile prosthesis approval status. For the all-payer analysis, data by payer were available and presented for 2019-2021 to assess approval status varied by payer and over time. For the employer-sponsored health plan analysis, data by payer were available from 2018-2021. RESULTS: Benefit verification records for the all-payer database were available for 3,167 patients in 2019, 3,016 in 2020, and 2,837 in 2021. Insurance type was preferred provider organization (27.5%), Medicare Advantage (26.9%), Medicare (15.9%), or point-of-service (10.5%). Most patients were approved or verified for implantable penile prosthesis coverage (79.4% in 2019, 79.6% in 2020, and 78.4% in 2021). Coverage was most extensive for government-based insurance (Medicare 98.7%, Medicare Advantage 97.1%, Tricare 100%, and Veterans Affairs 80.0%) but was also favorable for commercial insurance (75.0%). The most common reason for lack of coverage was employer exclusion; the proportion of patients with no coverage due to exclusion increased from 13.5% in 2019 to 17.5% in 2021. Analyses of the employer-sponsored health plan database (n=3,083 patients) showed that 63.1% of patients were approved or verified for coverage and 34.2% did not have coverage due to health plan exclusions. CONCLUSIONS: Approximately 80% of patients had implantable penile prosthesis coverage. Employer exclusion was the most common reason for lagging coverage; rates of employer exclusion increased 29.3% from 2019-2021.

Cardiovascular Safety of Testosterone-Replacement Therapy.

BACKGROUND: The cardiovascular safety of testosterone-replacement therapy in middle-aged and older men with hypogonadism has not been determined. METHODS: In a multicenter, randomized, double-blind, placebo-controlled, noninferiority trial, we enrolled 5246 men 45 to 80 years of age who had preexisting or a high risk of cardiovascular disease and who reported symptoms of hypogonadism and had two fasting testosterone levels of less than 300 ng per deciliter. Patients were randomly assigned to receive daily transdermal 1.62% testosterone gel (dose adjusted to maintain testosterone levels between 350 and 750 ng per deciliter) or placebo gel. The primary cardiovascular safety end point was the first occurrence of any component of a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, assessed in a time-to-event analysis. A secondary cardiovascular end point was the first occurrence of any component of the composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization, assessed in a time-to-event analysis. Noninferiority required an upper limit of less than 1.5 for the 95% confidence interval of the hazard ratio among patients receiving at least one dose of testosterone or placebo. RESULTS: The mean (±SD) duration of treatment was 21.7±14.1 months, and the mean follow-up was 33.0±12.1 months. A primary cardiovascular end-point event occurred in 182 patients (7.0%) in the testosterone group and in 190 patients (7.3%) in the placebo group (hazard ratio, 0.96; 95% confidence interval, 0.78 to 1.17; P<0.001 for noninferiority). Similar findings were observed in sensitivity analyses in which data on events were censored at various times after discontinuation of testosterone or placebo. The incidence of secondary end-point events or of each of the events of the composite primary cardiovascular end point appeared to be similar in the two groups. A higher incidence of atrial fibrillation, of acute kidney injury, and of pulmonary embolism was observed in the testosterone group. CONCLUSIONS: In men with hypogonadism and preexisting or a high risk of cardiovascular disease, testosterone-replacement therapy was noninferior to placebo with respect to the incidence of major adverse cardiac events. (Funded by AbbVie and others; TRAVERSE ClinicalTrials.gov number, NCT03518034.).

Increasing Role of the Advanced Practice Provider in Men's Health Clinics: An Analysis of Medicare and Commercial Claims in the United States.

INTRODUCTION: As urological care delivery in the U.S. continues to evolve to meet patient needs, we aim to clarify the role of advanced practice providers for publicly and privately insured patients in the treatment of male urological conditions commonly encountered in men's health clinics. METHODS: Medicare and commercial insurance claims from the Physician/Supplier Procedure Summary and Merative MarketScan Commercial Database were queried for procedures submitted by advanced practice providers between 2010 and 2021. Common urological conditions were identified using Current Procedural Terminology codes and grouped into 4 categories: testicular hypofunction, erectile dysfunction and Peyronie's disease, benign prostatic hyperplasia, and scrotal pain. The proportion of procedures submitted by advanced practice providers was calculated for each year and category. RESULTS: From 2010 to 2021, the proportion of advanced practice provider-submitted service counts for each condition within the MarketScan group increased up to 5-fold, with benign prostatic hyperplasia representing the greatest growth. The proportion of advanced practice provider-submitted service counts within the Medicare group increased up to 8-fold, with erectile dysfunction/Peyronie's disease representing the greatest fold change. The proportion of claims submitted by advanced practice providers treating all 4 conditions was higher in 2021 than 2010 in both publicly and privately insured groups. CONCLUSIONS: The role of advanced practice providers in men's urological health is increasing for both privately and publicly insured patient populations. Advanced practice providers play a critical role in urological care and can help to improve access to men's health.

Quantifying the number of US men with erectile dysfunction who are potential candidates for penile prosthesis implantation.

Introduction: Penile prosthesis implantation (PPI) is a treatment option recommended in clinical guidelines for erectile dysfunction (ED). However, a limited number of urologists perform PPI procedures in the United States. Aim: To quantify the number of insured men with ED in the United States and project the number of potential candidates for PPI in 2022. Methods: An Excel-based disease impact model was constructed using a top-down estimation approach. The starting US male population consisted of adult men from 2022 US Census data after exclusion of age-specific mortality rates from the National Vital Statistics Reports. Men with health insurance were included in the model based on insurance status data from the US Census database. ED prevalence and ED treatment rates were obtained from administrative claims data analyses-the Merative MarketScan Commercial Database (18-64 years) and the 5% Medicare Standard Analytical Files (≥65 years)-and literature-based estimates of patient-reported ED prevalence. Outcomes: The number of men with ED in the United States and the number of potential candidates for PPI were estimated. Results: By utilizing ED prevalence based on administrative claims, an estimated 8.3% of insured men (10,302,540 estimated men [8,882,548 aged 18-64 years and 1,419,992 aged ≥65 years]) had a diagnosis of ED and sought ED care, out of 124,318,519 eligible US men aged ≥18 years in 2022. An estimated 17.1% of men with an ED diagnosis claim could benefit from PPI in 2022 (1,759,248 men aged ≥18 years). Patient self-reported ED prevalence across all ages ranged from 5.1% to 70.2%. Scenario analyses applying the patient self-reported ED prevalence range revealed the number of men in the United States who could benefit from PPI could have been higher than 1.7 million if their ED symptoms were diagnosed by health care providers. Clinical Implications: Most men with ED in the United States are undertreated, and many could benefit from PPI. Strengths and Limitations: This analysis is a US population-level estimation. However, given this study utilized a variety of assumptions, the results may vary if different model assumptions are applied. Conclusions: This disease impact model estimated that approximately 10.3 million men were diagnosed with ED by their health care providers and sought ED care in the United States in 2022. Of those, 1.7 million men could be PPI candidates and benefit from the treatment option.

Oral testosterone therapy: past, present, and future.

INTRODUCTION: Testosterone replacement therapy (TRT) remains a commonly utilized treatment for men with testosterone deficiency (TD). Despite the recent FDA approval of new oral TRT medications, concerns remain regarding their efficacy and safety, and prescription rates for these medications have decreased compared to those for TD medications with other routes of administration. OBJECTIVE: In this study we sought to investigate the efficacy and safety of oral testosterone undecanoate (oTU), a new oral TRT medication. METHODS: A comprehensive review of the literature was performed using the Medline, EMBASE, and Cochrane Library databases; 1269 articles were identified, with 44 articles included in the final review and 12 used to perform meta-analyses to investigate the change in serum total testosterone (TT) and risk of adverse effects following oral testosterone undecanoate (oTU) use. Articles were also reviewed to investigate the reported effects of oTU on body composition, liver function, hematologic assays, lipid profiles, hormone assays, prostate growth, hypertension, and symptoms of TD. RESULTS: Across placebo-controlled randomized trials, there was no significant increase in TT for those receiving oTU vs placebo (mean difference, -0.26 [95% CI, -1.26 to 0.73]). On subanalysis, when eugonadal participants received oTU, a significant decrease in TT was demonstrated (mean difference -0.86 [95% CI, -1.28 to 0.43]). When participants who were hypogonadal at baseline received oTU, a significant increase in TT compared to placebo was seen (mean difference 1.25 [95% CI, 0.22-2.29]). There was no significant risk of adverse effects (RR, -0.03 [95% CI, -0.08 to 0.03]) or serious adverse effects (RR, 0.15 [95% CI, -0.66 to 0.96]) in the oTU groups compared to placebo. CONCLUSION: oTU was found to be well tolerated in hypogonadal patients, resulting in improved testosterone levels, height velocity, and sexual symptoms, without significant hepatotoxicity, prostatic enlargement, or worsening hypertension. There was no consensus regarding the effect of oTU on lean and fat mass percentages, hematologic assays, lipid profiles, mood, and general well-being.

Is there still a place for malleable penile implants in the United States? Wilson's Workshop #18.

The use of semirigid rod penile prosthesis for the management of erectile dysfunction was first described over 85 years ago. Since then, there have been numerous design advancements leading to improved overall durability, concealability, rigidity, and natural feel. However, the inflatable penile prosthesis (IPP) still has a higher patient satisfaction rate and is currently the most commonly inserted prostheses in the United States. There are still certain situations and conditions where the simplicity of a rod may be preferred over an IPP. A pair of semirigid rods has been shown to have less risk of malfunction and need for revision surgery. In addition, patients with poor manual dexterity, those undergoing a salvage for infection prosthesis and those with a prolonged (> 48 h) priapic episode may be better served with a rod than an IPP. Finally, in patients compromised by infection or priapism, the rods can later successfully be exchanged for an IPP with potentially longer, wider cylinders with resultant greater patient satisfaction.

First-time orgasm in a young man with lifelong anorgasmia after flibanserin use: a case report.

Introduction: Anorgasmia is a poorly understood phenomenon defined as either a lifelong or acquired consistent inability to achieve ejaculation. Despite the prevalence of anorgasmia, there is currently no established treatment for the condition. Aims: To report a unique case of a patient with lifelong anorgasmia who was able to achieve his first orgasm with off-label use of flibanserin. Methods: The present case study relies on the patient's self-report and a review of the relevant literature. The patient provided written informed consent. Results: A 28-year-old male presented to our office with complaints of lifelong anorgasmia, without any signs of erectile dysfunction. He reported good libido and energy levels and denied any urinary symptoms or history of depression. The patient failed medical management with numerous off-label medications, including bupropion and bremelanotide. Despite having received 4 or 5 sex therapy sessions over 3 months, the patient reported that this treatment approach was not effective. Off-label use of flibanserin was then initiated, and after 28 to 32 doses over 4 weeks, he achieved his first orgasm. Notably, the patient experienced nocturia and insomnia. The follow-up International Index of Erectile Function score marginally improved by 2 points without any improvement in the overall satisfaction subdomain. Conclusion: This case highlights the challenges of managing anorgasmia and anejaculation in a young male patient. A stepwise approach involving pharmacotherapy and sex therapy was not successful. However, the off-label use of flibanserin ultimately resulted in the patient achieving his first orgasm, albeit with some side effects. Further studies are needed to evaluate the efficacy and safety of flibanserin in men for this indication.

Is urgent surgical management necessary for priapism in pediatric patients with hematologic conditions?

INTRODUCTION: Acute priapism is usually considered a medical emergency that warrants prompt urologic evaluation and treatment. Efforts have been made to determine the optimal management strategy for pediatric priapism. OBJECTIVE: The aim of this study is to assess differences in conservative, minimally-invasive, and operative management of acute priapism in the pediatric population. STUDY DESIGN: A retrospective study of pediatric patients with acute priapism from 2015 to 2021 at a single tertiary care children's hospital was conducted. Conservative, minimally-invasive, and operative approaches for the priapism episodes during these hospital encounters were analyzed. RESULTS: Thirty-nine patients were identified with a total of 61 cases of acute pediatric priapism were evaluated in the study period. Eight-three percent of patients were African-Americans, and 72% of patients had a history of sickle cell disease. Oxygen therapy (P = 0.001) and hydration with intravenous fluids (P = 0.00318) were more commonly utilized for hematologic-associated cases compared to other etiologies. For priapism episodes of hematologic etiology, 18 (40.0%) and 18 (40.0%) patients received phenylephrine injection and aspiration/irrigation (e.g., minimally-invasive therapy), respectively, while for the other causes of priapism, three (18.8%) and four (25.0%) received phenylephrine injection and aspiration/irrigation (e.g., minimally-invasive), respectively. Conservative and minimally-invasive treatment resulted in complete resolution of priapism in 27 (60%) and 16 (35.5%) patients with hematologic-associated priapism while 12 (75%) and 1 (6.3%) patients with other etiologies had resolution of priapism with conservative and minimally-invasive treatment, respectively. One patient received shunting in the hematologic group while two patients received shunting in the non-hematologic group (P = 0.1031). DISCUSSION: Hematologic disorders are the most common causes of priapism in children and adolescents. An overwhelming majority of priapism events in the pediatric population can be managed with conservative therapies including oxygenation and intravenous hydration as well as minimally-invasive procedures such as corporal aspiration, irrigation and/or injections. The utilization of corporal shunting, anesthesia, and hospital resources is infrequently necessary for pediatric priapism episodes. CONCLUSION: While urgent surgical management is often performed in the adult population, a minimally-invasive management strategy can be implemented in the pediatric population where an extended period of conservative management that avoids operative management and general anesthesia is effective.

The Low Submuscular Reservoir Placement With Transfascial Fixation for Inflatable Penile Prostheses.

BACKGROUND: Several techniques have been described for placement of inflatable penile prostheses (IPP) reservoirs, with variable satisfaction. Standard placement in the Space of Retzius can present with several complications and may be technically difficult in patients with a violated space. Concerns with ectopic reservoir placement have included reservoir herniation and lack of reservoir concealability. AIM: To present a novel technique to achieve reservoir concealment with decreased postoperative complications as an alternative to standard approaches of ectopic reservoir placement. METHODS: We describe our novel low submuscular reservoir (LSM) placement with transfascial fixation (TFF) for inflatable penile prostheses. OUTCOMES: Patient satisfaction with reservoir concealment, complication rate or need for additional surgeries. RESULTS: A total of 31 cases successfully underwent our technique. The low submuscular placement with TFF of the IPP reservoir offers an optimal approach for reservoir placement with a high degree of patient satisfaction with significant ease of placement compared to alternative methods. CLINICAL IMPLICATIONS: Penile prosthetic surgeons should be familiar with several techniques for concealment of reservoir as an option to improve patient satisfaction. STRENGTHS AND LIMITATIONS: Given the small sample size of patients who have undergone this novel technique, current literature regarding the topic is limited. CONCLUSION: Low submuscular reservoir placement with transfascial fixation for IPPs is a technically feasible approach that can be employed to achieve patient satisfaction and decrease the risk of reservoir herniation. Khoei A, Racik N, Bansal U, et al. The Low Submuscular Reservoir Placement With Transfascial Fixation for Inflatable Penile Prostheses. J Sex Med 2022;19:1309-1312.