Ziegelmann, Matthew

Abstract Introduction The AUA Census offers broad insight into urology, however, there is limited information reported regarding sub-specialists. We designed a survey to capture similar data among urologists who treat male sexual health, including demographics, clinical practice characteristics, and job satisfaction. Objective To characterize the demographics, practice characteristics and job satisfaction of providers who treat male sexual health. Methods A survey was developed and distributed to all relevant professional urological societies for male sexual health providers, including GURS, ISSM, SMSNA and SUPS. Averages, modes, counts, and ranges were examined. The survey remains open and additional responses are expected. Preliminary analysis as of June 15, 2022, yielded 76 responses; 58 were complete. Results The survey remains open and additional responses are expected. Preliminary analysis as of June 15, 2022, yielded 76 responses; 58 were complete. Demographics: The average age of respondents is 42 years old. 52 (89.6%) respondents self-identify as male, 6 (10.4%) as female. 67% of respondents identify as white (n=39), 7% identify as Asian (n=4), 7% identify as Black or African American (n=4), 2% identify as American Indian/Native American or Alaskan Native (n=1) and 17% preferred not to select a race or selected “other” (n=10); respondents were able to select more than one racial identity. 16% of respondents identified themselves as having Hispanic ethnicity (n=9). 84% of respondents are married (n=49) with 21% divorced or currently going through a divorce (n=12). On average, respondents have 1.5 children (range: 0-3, mode: 2). Work-life: The majority (58%) of respondents work in academic practice (n=34). 19% work in private practice (n=11). Employed physician, multispecialty, solo and hybrid private-VA practices make up the remaining 22% (n=4, 5, 3, 1 respectively). 72% of respondents practice in cities with a population greater than 500,000 (n=42), 12% work in cities with populations between 100,000 – 500,000 (n=7), 14% serve towns of less than 100,00 (n=8). Satisfaction: The survey asked providers binary yes/no questions about career satisfaction. 88% affirmed “I would pursue this career again” (yes, n=51; no, n=7). 69% affirmed “I am satisfied with my current level of compensation” (yes, n=40; no, n=18). 52% affirmed “I am satisfied with my current work-life balance” (yes, n=30; no, n=28). Female responders were significantly more likely to indicate that they are dissatisfied with work-life balance (p=0.0074).100% of female respondents reported dissatisfaction compared to 42% of males. Conclusions To our knowledge, this survey is the first survey exclusively of male sexual health providers. Among survey respondents, the average practitioner is white, male, and married with two children under 18. They are in the first half of their career at an academic institution in an urban area. Although nearly 90% would choose their career again, 50% are dissatisfied with work-life balance. Gender has a significant impact on satisfaction. While averages reflect low diversity within the field, they suggest that gender parity is on track with national trends while racial and ethnic diversity may exceed that of general urology (ref 1). Disclosure No

Abstract Introduction Inflatable penile prosthesis (IPP) placement is associated with high postoperative patient satisfaction. Patients often express concerns about postoperative penile length. There is scant evidence in the literature of clinical and surgical factors that predict IPP length. Objective To evaluate predictors of cylinder length for men undergoing primary IPP placement in a large multicenter cohort. Methods Patients undergoing primary IPP placement for treatment of erectile dysfunction at 16 high-volume implant centers were included. All patients had preoperative demographics, surgical characteristics, and device length retrospectively collected at their respective institutions and combined for analysis. Descriptive statistics were reported for the full group. Univariate analysis was utilized to isolate variables significantly associated with device length and all variables reaching p<0.1 were included in linear regression modeling. Results 3,953 men underwent primary IPP placement. The mean age was 61.8±10.4 years and BMI was 29.8±4.2 kg/m2. The mean total device length was 20.6±2.1cm. 1291 (32.7%) had diabetes mellitus, 641 (16.2%) were smokers, 705 (17.8%) had a prior radical prostatectomy, 195 (4.9%) had prior radiation, 549 (13.9%) had Peyronie’s disease, and 884 (22.4%) had a history of intracavernosal injections. In univariate analysis, BMI (B=0.05, 95%CI 0.04 to 0.07, p<0.001), a history of Peyronie’s disease (20.4 vs 20.6cm, p=0.02), and use of intracavernosal injection (20.7 v 20.9cm, p=0.02) were predictors of shorter total device length. Use of rear tip extenders (20.7 v 20.0cm, p<0.001), penoscrotal approach (21.0 v 20.3, p<0.001), and single corporal dilation (20.8 v 20.4cm, p<0.001) were associated with longer length. In multivariable analysis, a history of Peyronie’s disease (B=-0.29, 95%CI -0.47 to -0.11, p=0.002) and greater BMI (B=0.05, 95%CI 0.03 to 0.07, p<0.001) were predictors of shorter total device length. Independent predictors of longer device length were penoscrotal approach (B=-0.85, 95%CI -1.03 to -0.65, p<0.001), rear tip extender use (B=1.00, 95%CI 0.84 to 1.17, p<0.001), and single corporal dilation (B=-0.5, 95%CI -0.67 to -0.34, p<0.001). Conclusions In this series, Peyronie’s disease and greater BMI are independent predictors of shorter IPP device length, while use of rear tip extenders, single corporal dilation, and penoscrotal approach are independent predictors of longer device length. These results are important in counseling patients regarding expectations of postoperative length. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Intuitive Surgical, Fidelis, Urofill, Boston Scientific, Endo Pharma, Coloplast, Cynosure, Antares Pharma, Clarus Pharmaceuticals, Acerus Pharma

Abstract Introduction Intralesional Collagenase Clostridium Histolyticum (CCH; Xiaflex; Endo Pharmaceuticals, Dublin, Ireland) is the only FDA-approved intralesional therapy to treat bothersome penile curvature in men with Peyronie’s Disease (PD). Clinicians who administer CCH must be certified through a risk evaluation and management strategy (REMS) program. However, provider availability is highly dependent on geography and many patients must travel great distances to undergo evaluation and treatment with CCH by an experienced injector. Objective The goal of the current study is to describe the landscape of certified CCH injectors with respect to location and clinical background/training. Methods Patients are currently able to use an online “locate a specialist” tool through Endo Pharmaceuticals to identify clinicians in their local geographic area who are certified to administer CCH. Using this tool, a list of all providers who offer CCH injections was compiled throughout the continental United States. Pertinent information that was gathered included geographic location, type of provider or level of training [Medical Doctor (MD), Doctor of Osteopathic Medicine (DO), Physician Assistant (PA), Nurse Practitioner (NP), and Registered Nurse (RN)], and gender of providers. This information was compared to state population data (United State Census Bureau) to determine per capita coverage. Results A total of 1947 Xiaflex providers were identified: 1749 Doctors of Medicine (MD; 90%), 115 Doctor of Osteopathic Medicine (DO; 6%), 60 Physician Assistants (PA; 3%), 21 Nurse Practitioners (NP; 1%), and 1 Registered Nurse (RN; 0.05%). Out of the 1947 providers, only 95 (4.9%) were women. Most women administering Xiaflex were MDs (73%), followed by PAs (12%), NP and DOs (7%), and RN (1%). Xiaflex providers were available in all states except for Hawaii and Alaska. Providers were distributed throughout the United States with the average provider per capita ratio of 230,240. Wyoming, Washington D.C., Rhode Island, and Georgia had the best provider per capita at <10,000 while New Mexico had the worst provider per capita ratio at 2,117,522. Conclusions Our results show significant variation in certified CCH injector availability for patients across the United States. < 5% of all certified clinicians are female and 4% were advanced practice providers. Further work is needed to characterize and remedy gender disparities amongst providers, and ensure greater access for patients who desire an FDA-approved non-surgical treatment for their PD-associated curvature. Disclosure No

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 Collagenase clostridium histolyticum (CCH) is the only food and drug administration (FDA) approved intralesional medication for Peyronies Disease (PD). The manufacture instructions recommend a single injection into the plaque at the point of maximal curvature. However, a 2019 survey of the Sexual Medicine Society of North America (SMSNA) found that physicians were utilizing many different injection techniques. It is unknown if one technique is superior. Objective To assess delivery of medication into PD plaques using an invitro model. Methods We obtained PD plaques from men undergoing plaque excision and grafting. Plaques were stored at -80C until ready for use in the lab. We injected the plaques with 0.25ml of Eosin Y, 5 wt. 5% solution in water because this solution is visibly red and similar to the density of CCH. We assess how the dye spread through the plaque in four different injection techniques: single injection, single injection with slow pull back, multiple site injection and lateral injection. All injections were video recorded in real time. Results Dye was retained inside the plaques will all injection techniques, however in all conditions, a significant amount of dye leaked out of the plaques. Multiple injection technique appeared to have the least about of dye leak out of the plaque. Conclusions In all conditions, dye leaked out of the plaques, however the multiple injection technique appears to have deliver the greatest amount Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Endo Pharmaceuticals

Abstract Introduction Penile duplex Doppler ultrasound (PDDU) is an important test to diagnose and guide treatment recommendations for peyronie’s Disease and erectile dysfunction. When patients do not achieve optimal rigidity during their evaluation we may be underestimating their degree of curvature and erection response which can impact treatment recommendations. Objective To evaluate specific examination conditions that may negatively impact the patient experience in men undergoing PDDU. Methods We developed a survey to evaluate patient experience during PDDU. Specific questions addressed preferences regarding the type of clinician performing the examination (physician versus advanced practice provider), provider gender, and specific modifiable conditions about the examination room. The survey was administered to thirty-five consecutive patients at a single academic practice. Patients were asked to complete portions of the survey before and after the examination to limit bias. Results 113 patients completed the survey. Prior to starting the testing, 48% of patients (n=54) had no provider preference, whereas 43% (n=49) preferred a physician as the performing clinician. 70% of patients (n=79) had no provider gender preference. All patients received at least a single dose of intracavernosal erectogenic medication at the start of their assessment. After completing PDDU, 40% of patients (n=45) reported that room conditions negatively impacted their ability achieve an adequate erectile response in the clinic. As shown in Figure 1, bright fluorescent overhead lighting (29%) and hallway noise (21%) were the most frequent contributing factors. When asked about opportunities to improve future patient experience, 38% (n=43) recommended dimming the room lights, 31% (n=35) would enjoy a warm blanket, and 36% (n=41) would favor gentle music or background sounds. 32% (n=36) felt that using call button, as opposed to routine staff checks to verify erectile response, would be desirable. Despite these preferences, the mean overall patient experience on a scale of 0-10 (0=poor, 10=excellent) was high at 9.3 (SD 1.2). Conclusions Despite high patient-reported satisfaction, we found that patients undergoing PDDU for PD and ED reported a preference towards (i) softer/dimmer lights, (ii) sound machine to drown out hallway noise, (iii) aa warm blanket, (iv) a call system to alert staff of a satisfactory erectile response. Further investigations are necessary to determine whether these simple modifications can improve the patient experience and exam efficiency. Disclosure No

Abstract Introduction Sexual therapy for male sexual dysfunction has been used to help patients address a variety of sexual dysfunction-related conditions. While this intervention is frequently recommended for patients by male sexual health experts, the rate of adherence to the recommended therapy and associated factors is unknown. Objective To understand factors leading to completion of sex therapy consultations and barriers that prevent it. Methods A survey was developed by experts in the management of male sexual dysfunction and sex therapy at our institution. The survey included questions focusing on the decision to pursue sex therapy (or not), barriers or facilitating factors, patient perceptions regarding the referral, and treatment success. A retrospective chart review was performed to identify those patients who were referred for sexual therapy after undergoing evaluation for male sexual dysfunction at an academic Men’s Health urology clinic from 2017 - present. The survey was mailed out to these patients, and respondent survey data was compiled to evaluate survey responses. Results To date, 23 patients completed the survey (20% response rate). Sixty-five percent of survey respondents were ≥ 50 years of age, 87% were straight, and 71% were married. Reasons for sex therapy referral were frequently multi-factorial and included erectile dysfunction (65%, n=15), low libido (43%, n=10), ejaculatory dysfunction (39%, n=9), performance anxiety (30%, n=7), relationship problems (30%, n-7), and genital pain (14%, n=3). Seventy-eight percent of patients (n=18) felt that sex therapy consultation was a reasonable part of their treatment plans. Six (26%) patients did not attend their recommended sex therapy consultations. Reported barriers included sense of shame (n=2), embarrassment (n=2), scheduling conflicts (n=1), lack of anticipated benefits (n=1), and feeling dismissed by the referring provider (n=2). Those who attended sex therapy frequently reported the perception that referral made sense based on their symptoms (n=10, 59%) and/or a feeling of desperation to “do anything do get better” (n=11, 65%). Seventy-eight percent of patients who attended sex therapy found it helpful and would recommend it to a friend with a similar concern. Conclusions The majority of male patients who are referred to sexual therapy feel it is beneficial. However, one in four men choose not to pursue this line of treatment despite recommendations from their treating physicians. Future work is needed to address barriers to pursuing sex therapy. Disclosure No

Abstract Introduction Medical policy bulletins (also known as clinical policy bulletins) are insurance company guidelines for administering plan benefits. These documents purport to summarize current research, evidence-based guidelines, regulatory status, and physician opinion to determine whether insurers consider procedures and services to be medically necessary. These bulletins, along with member benefit plans, determine which services are covered. We have previously explored the lack of uniformity that exists for insurance payer coverage for penile prostheses. Here, we sought to expand this investigation to determine insurance coverage criteria for medical and surgical management of common men’s health conditions. Objective To determine covered benefits for sexual medicine conditions among the top United States healthcare insurers. Methods A list of common sexual medicine conditions was generated, including Peyronie’s disease, hypogonadism, erectile dysfunction, premature ejaculation, incontinence, and buried penis. The most common treatment modalities for each condition were identified (see Table I). Securities and Exchange Commission (SEC) filings were used to identify the top ten largest private insurers in the United States by member enrollment. This list was cross-referenced with the National Association of Insurance Commissioners (NAIC) 2020 Market Share Report (ref 1). The following list of the largest private US health insurers was thus developed: United, Anthem, Centene, Kaiser, Humana, CVS, Healthcare Service Corporation (HCSC), Cigna, Molina, and Independence Health Group (IBX). Kaiser and Centene were excluded due to lack of nationwide medical policy bulletins. We reviewed medical policy bulletins from the remaining 8 insurers to determine whether the specific treatments were identified as medically necessary, experimental/investigational, or cosmetic. Services and procedures deemed medically necessary were coded as “covered,” and those listed as investigational, or cosmetic were coded as “not covered.” If information about a specific condition or treatment modality was not found in a company’s policy bulletin, it was coded as “unknown.” Results In total, we recorded 143 data points, across the 8 insurance providers. Our review of medical policy bulletins yielded 60 (41.9%) instances where services were considered medically necessary and/or “covered”, 18 (12.6%) non-covered or investigational/cosmetic services, and 65 (45.5%) services with unknown coverage (Table I; covered=1, non-covered=0, unknown=2). Conclusions We encountered substantial difficulty in navigating and interpreting insurance coverage for various sexual medicine treatments and conditions based on review of policy bulletins from the topic insurance providers in the US. There was no readily identifiable coverage information for >45% of the data points that we collected, and instances of “unknown” coverage exceeded covered services across the collective of the largest private insurers. While 76.9% of conditions for which there was available data were covered, we are unable to draw generalizable conclusions for most conditions as there are significant deficits in the availability of policy information from online insurance sources. Further challenges in determining coverage include the additional layers of limitations in member plan benefits (i.e. plan exclusions), which could compound confusion for both physicians and patients. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast.

Abstract Introduction Sexual Health Curriculum (SHC) in medical schools has been insufficiently training medical students for many years. While most medical schools report teaching a SHC, many medical students and residents report being inadequately trained in sexual health. This has led to infrequent physician screening for sexual problems due to insufficient knowledge and a lack of training about sexual function and dysfunction. Objective To investigate the current body of literature for changes in SHC in medicals schools in the last 20 years, and to identify any discrepancies between SHC taught in medical school and resident and medical student comfort in treating Sexual Health Dysfunction. Methods A literature review was conducted in PubMed on “sexual health education in medical school”, and of 16,962 results 37 relevant papers published in the U.S. and Europe were identified and analyzed. Results In 2003 86% of medical schools reported teaching over 3 hours of SHC, but by 2021 only 65% of students and 50% of PGY 4/5 Urology residents recalled a dedicated SHC in medical school. Consistently 50% of medical students are unsatisfied with their SHC, 52% are rarely or never evaluated on their sexual history taking skills, and 7% report not learning about human sexuality at all. Most German medical students believe that sexual health courses should be mandatory. Medical students have overall positive attitudes towards sexual and gender minority populations but lack adequate knowledge, especially about transgender and intersex health. Only 55% of 3rd/4th year OBGYN residents reported feeling comfortable in performing a targeted sexual dysfunction exam, and 66% of residents in Family Med, IM, OBGYN, and Psych had no previous educational experience in sexual problem management. Conclusions Sexual health curriculum in medical schools has not significantly improved in the last 20 years, leading to students and residents inadequately prepared to treat sexual health dysfunctions. The adoption of previously proposed SHC competencies for medical schools should be strongly considered. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast

Abstract Introduction The American Urological Association (AUA) recommendations on antibiotic prophylaxis in penile implant surgery are based on low quality evidence and expert opinion. Recent evidence suggests the recommended regimens may be suboptimal. Objective To determine if the AUA recommended antibiotic regimen (vancomycin + gentamicin) for primary penile implant surgery is associated with a higher infection risk than non-standard regimens. Methods We performed a multicenter, retrospective cohort study of patients undergoing primary IPP surgery. Patients undergoing revision surgery or with a history of IPP placement were excluded. Additionally, patients who underwent concomitant procedures for Peyronie’s disease or stress urinary incontinence were excluded. Patients were divided into those receiving standard AUA antibiotic prophylaxis (vancomycin + gentamicin) and those receiving any other (non-standard) antibiotic prophylaxis. The time to postoperative device explanation due to infection via a Cox regression model, the microorganisms involved, and the management of patients with device infection were evaluated. A subgroup analysis to identify the appropriate dosage of gentamicin was also performed. Results 4,161 patients underwent primary IPP placement (2,411 received vancomycin + gentamicin and 1,750 received other regimens). The infection rate was similar between groups, 1.0 vs 1.2% for standard vs non-standard prophylaxis. In the multivariate Cox regression analysis, the use of vancomycin + gentamicin (HR: 2.74, 95%CI: 1.38-5.41, p=0.004) and diabetes (HR: 1.87, 95%CI: 1.03-3.39, p=0.04) were significantly associated with higher risk of device explantation due to infection. Concomitant infusion of antifungals (HR: 0.08, 95%CI: 0.03-0.19, p<0.001) was associated with lower risk of infection. Staphylococcus aureus and Escherichia coli were the most frequently cultured microorganisms. Device infection was most commonly managed with salvage using a malleable prosthesis (40.4%). In patients of both groups receiving gentamicin as part of perioperative antibiotic prophylaxis, the use of weight-based gentamicin compared to 80 mg gentamicin was associated with similar risk of device explantation due to infection (HR: 2.88, 95% CI: 0.83 to 10, p = 0.1). Conclusions Vancomycin + gentamicin for antibiotic prophylaxis in primary penile implant surgery is independently associated with a higher infection risk than non-standard antibiotic regimens while antifungal use is associated with lower infection risk. There does not appear to be a difference in weight-based vs low dose (80mg) gentamicin on infection risk. Our results further demonstrate the importance of antifungal use in prophylaxis regimens. Additionally, a critical review of the recommended prophylactic regimens is needed. Tailoring individual regimens to local antibiograms may provide the best infection prevention. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Boston Scientific, Antares Pharma, Clarus Therapeutics, Cynosure, Promescent, Sprout, Viome.