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.

Does climate impact inflatable penile prosthesis infection (IPP) risk? Assessment of temperature and dew point on IPP infections.

BACKGROUND: Variations in climate have been associated with a greater risk of surgical site infections, urinary tract infections, and changes in the skin microbiome; however, limited data exist on the impact of climate on inflatable penile prosthesis (IPP) infections. AIM: We sought to evaluate the impact of climate on the risk of IPP infections in a large international, multicenter cohort. METHODS: We performed a multi-institutional, retrospective study of patients undergoing IPP surgery. We then evaluated whether the month or season, during which surgery was performed, affected device infections. Implant infections were defined as infections requiring device explantation. A univariate logistic regression analysis was undertaken. OUTCOMES: Our primary outcome was implant infection. RESULTS: A total of 5289 patients with a mean age of 62.2 ± 10.8 years received IPP placement. There was a fairly even distribution of implants performed in each season. A total of 103 (1.9%) infections were recorded. There were 32 (31.1%) IPP infections in patients who underwent surgery in the summer, followed by 28 (27.2%) in the winter, 26 (25.2%) in the spring, and 17 (16.5%) in the fall. No statistically significant differences were recorded in terms of season (P = .19) and month (P = .29). The mean daily temperature (P = .43), dew point (P = .43), and humidity (P = .92) at the time of IPP placement was not associated with infection. CLINICAL IMPLICATIONS: These findings provide reassurance to prosthetic urologists that infection reduction strategies do not need to be tailored to local climate. STRENGTHS AND LIMITATIONS: Climate data were not directly recorded for each hospital, but rather based on the monthly averages in the city where the surgery was performed. CONCLUSION: The climate at time of IPP placement and time of year of surgery is not associated with IPP infection risk.

AUA-recommended Antibiotic Prophylaxis for Primary Penile Implantation Results in a Higher, Not Lower, Risk for Postoperative Infection: A Multicenter Analysis.

PURPOSE: Our aim was to determine if the AUA-recommended prophylaxis (vancomycin + gentamicin alone) for primary inflatable penile prosthesis surgery is associated with a higher infection risk than nonstandard regimens. MATERIALS AND METHODS: We performed a multicenter, retrospective study of patients undergoing primary inflatable penile prosthesis surgery. Patients were divided into those receiving vancomycin + gentamicin alone and those receiving any other regimen. A Cox proportional-hazards model was constructed adjusted for major predictors. A subgroup analysis to identify the appropriate dosage of gentamicin was also performed. RESULTS: A total of 4,161 patients underwent primary inflatable penile prosthesis placement (2,411 received vancomycin + gentamicin alone and 1,750 received other regimens). The infection rate was similar between groups, 1% vs 1.2% for standard vs nonstandard prophylaxis. In the multivariable analysis, vancomycin + gentamicin (HR: 2.7, 95% CI: 1.4 to 5.4, P = .004) and diabetes (HR: 1.9, 95% CI: 1.03 to 3.4, P = .04) were significantly associated with a higher risk of infection. Antifungals (HR: 0.08, 95% CI: 0.03 to 0.19, P < .001) were associated with lower risk of infection. There was no statistically significant difference in infection rate between weight-based gentamicin compared to 80 mg gentamicin (HR: 2.9, 95% CI: 0.83 to 10, P = .1). CONCLUSIONS: Vancomycin + gentamicin alone for antibiotic prophylaxis for primary inflatable penile prosthesis surgery is associated with a higher infection risk than nonstandard antibiotic regimens while antifungal use is associated with lower infection risk. A critical review of the recommended antimicrobial prophylactic regimens is needed. Prospective research is needed to further elucidate best practices in inflatable penile prosthesis antimicrobial prophylaxis.

Penetrative anal intercourse may require high axial loading forces.

BACKGROUND: Despite increases in the lifetime prevalence of anal intercourse, little is known about the safety of inflatable penile prosthesis use during anal intercourse or the forces required for anal penetration. AIM: We sought to determine the force required for anal penetration. METHODS: A digital force gauge device was secured to a silicone phallus with a length and girth representative of the average male phallus in the United States and inserted into the anal canal of 6 male participants for a total of 5 measurements per participant. The maximum axial forces on insertion were recorded. Participants then completed a survey eliciting demographic information and past experience with receptive anal intercourse. OUTCOMES: The outcome measure was the force recorded during insertion of a force gauge device into the anal canal. RESULTS: The median maximal force recorded on anal penetration was 26.5 N (2.7 kg; range: 16.1-51.7 N or 1.64-5.27 kg). Participants who engaged in receptive anal intercourse more than once per month tended to use lesser median maximal forces (25.7 N or 2.62 kg) than participants who engaged less frequently in receptive anal intercourse (41.6 N or 4.24 kg). CLINICAL IMPLICATIONS: Compared with the forces required for vaginal penetration, anal penetration forces may cause additional mechanical stress to the phallus. STRENGTHS AND LIMITATIONS: While the study is limited primarily in its small sample size and in the use of a single device for anal penetration with a set size and rigidity, the resulting findings presented here are to our knowledge the first reported data pertaining the force required for anal penetration. CONCLUSION: As the forces required for anal penetration exceeded those for vaginal penetration, clinicians may need to carefully counsel patients on the safe use of an inflatable penile prosthesis for anal intercourse.

Delayed placement of an inflatable penile prosthesis is associated with a high complication rate in men with a history of ischemic priapism.

BACKGROUND: Corporal fibrosis is known to result from prolonged priapism; however, the impact of the timing of penile prosthesis placement after priapism on complication rates is poorly understood. AIM: We sought to evaluate the impact of timing of inflatable penile prosthesis (IPP) placement on complications in men with a history of ischemic priapism. METHODS: We performed a multicenter, retrospective cohort study of patients with a history of priapism undergoing IPP placement by 10 experienced implantation surgeons. We defined early placement as ≤6 months from priapism to IPP. We identified a 1:1 propensity-matched group of men without a history of priapism and compared complication rates between men who had early placement, late placement, and no history of priapism. OUTCOMES: Our primary outcome was postoperative noninfectious complications, and secondary outcomes included intraoperative complications and postoperative infection. RESULTS: A total of 124 men were included in the study with a mean age of 50.3 ± 12.7 years. A total of 62 had a history of priapism and 62 were matched control subjects. The median duration of priapism was 37 (range, 3-168) hours and the median time from ischemic priapism to IPP placement was 15 months (range, 3 days to 23 years). Fifteen (24%) men underwent early (≤6 months) IPP placement at a median time of 2 months (range, 3 days to 6 months) following the ischemic priapism event. The remaining 47 (76%) underwent placement >6 months following priapism at a median time of 31.5 months (range, 7 months to 23 years). The complication rate in the delayed placement group was 40.5% compared with 0% in the early placement group and control group. Cylinder-related complications such as migration or leak accounted for 8 (57%) of 14 of the postoperative noninfectious complications. Full-sized cylinders were used in all patients who had a cylinder related complication. CLINICAL IMPLICATIONS: Priapism patients should be referred to prosthetic experts early to decrease complication rates in those needing an IPP. STRENGTHS AND LIMITATIONS: This is a multicenter study from experienced prosthetic urologists but is limited by the retrospective nature and small number of patients in the early placement group. CONCLUSION: IPP complication rates are high in men with a history of ischemic priapism, especially when implantation is delayed beyond 6 months.

Comparison of Outcomes for Hypogonadal Men Treated with Intramuscular Testosterone Cypionate versus Subcutaneous Testosterone Enanthate.

PURPOSE: Intramuscular testosterone cypionate (IM-TC) is known to cause significant rises in estradiol (E2), hematocrit (HCT), and prostate specific antigen (PSA) due to its supraphysiological testosterone peaks, whereas a novel subcutaneous testosterone enanthate autoinjector (SCTE-AI) was designed with a lower testosterone peak-to-trough ratio to mitigate these reactions. We compare the total testosterone (TT), E2, HCT and PSA response to treatment with IM-TC versus SCTE-AI. MATERIALS AND METHODS: A total of 234 hypogonadal men were treated with testosterone replacement therapy (TRT) via IM-TC 100 mg weekly or SCTE-AI 100 mg weekly. TT, E2, HCT and PSA levels were obtained at baseline and 12 weeks post-treatment. Significant differences in baseline and post-treatment levels were identified by univariate analysis. Linear regression models determined whether treatment modality was independently associated with post-TRT levels of TT, E2, HCT and PSA. RESULTS: Post-TRT, both cohorts had significant increases in trough TT compared to their baseline levels (IM-TC: 313.6 ng/dL to 536.4 ng/dL, p <0.001; SCTE-AI: 246.6 ng/dL to 552.8 ng/dL, p <0.001). After linear regression, type of TRT modality was not found to be associated with TT levels (p=0.057). SCTE-AI was independently associated with lower post-therapy E2 (p <0.001) and HCT (p <0.001). Neither TRT modality was associated with significant post-therapy elevation of PSA (p=0.965). CONCLUSIONS: While IM-TC and SCTE-AI provide a significant increase in TT levels, SCTE-AI is associated with lower levels of post-therapy HCT and E2 compared to IM-TC after adjusting for significant covariates. SCTE-AI is an effective testosterone delivery system with a potentially preferable safety profile over IM-TC.

The Diagnosis and Management of Recurrent Ischemic Priapism, Priapism in Sickle Cell Patients, and Non-Ischemic Priapism: An AUA/SMSNA Guideline.

PURPOSE: Priapism is a persistent penile erection that continues hours beyond, or is unrelated to, sexual stimulation and results in a prolonged and uncontrolled erection. Given its time-dependent and progressive nature, priapism is a situation that both urologists and emergency medicine practitioners must be familiar with and comfortable managing. METHODOLOGY: A comprehensive search of the literature on acute ischemic priapism and non-ischemic priapism (NIP) was performed by Emergency Care Research Institute for articles published between January 1, 1960 and May 1, 2020. A search of the literature on NIP, recurrent priapism, prolonged erection following intracavernosal vasoactive medication, and priapism in patients with sickle cell disease was conducted by Pacific Northwest Evidence-based Practice Center for articles published between 1946 and February 19, 2021. Searches identified 4117 potentially relevant articles, and 3437 of these were excluded at the title or abstract level for not meeting inclusion criteria. Full texts for the remaining 680 articles were ordered, and ultimately 203 unique articles were included in the report. RESULTS: This Guideline provides a clinical framework for the treatment (non-surgical and surgical) of NIP, recurrent ischemic priapism, and priapism in patients with sickle cell disease. The treatment of patients with a prolonged erection following intracavernosal vasoactive medication is also included. The AUA guideline on the diagnosis of priapism and the treatment of acute ischemic priapism was published in 2021. CONCLUSIONS: All patients with priapism should be evaluated emergently to identify the sub-type of priapism (acute ischemic versus non-ischemic) and those with an acute ischemic event should be provided early intervention when indicated. NIP is not an emergency and treatment must be based on patient objectives, available resources, and clinician experience. Management of recurrent ischemic priapism requires treatment of acute episodes and a focus on future prevention of an acute ischemic event. Sickle cell disease patients presenting with an acute ischemic priapism event should initially be managed with a focus on urologic relief of the erection; standard sickle cell assessment and interventions should be considered concurrent with urologic intervention. Treatment protocols for a prolonged, iatrogenic erection must be differentiated from protocols for true priapism.

Evidence for the integration of total and free testosterone levels in the management of prostate cancer.

OBJECTIVE: To comprehensively assess total and calculated free testosterone levels in a consecutive group of patients with prostate cancer (PCa) and any potential impact on disease aggressiveness and recurrence outcomes. PARTICIPANTS AND METHODS: The study included a single-centre prospective cohort of 882 patients presenting for radical prostatectomy from 2009 to 2018. Data on total testosterone (TT), sex hormone-binding globulin (SHBG), and calculated free testosterone (cFT) were prospectively collected. Stepwise logistic regression models were used to assess correlations of TT and cFT with pathological Gleason Grade Group (GGG), extraprostatic extension (EPE), seminal vesicle invasion (SVI) and biochemical recurrence (BCR). RESULTS: Total testosterone remained nearly constant across decades (40s-80s): 0.09 decrease/year (R = 0.02), while SHBG increased 0.87/year (R = 0.32) and cFT decreased 0.08/year (R = -0.02). Low cFT of <5.5 independently predicted: very-high-risk GGG (odds ratio [OR] 0.435, 95% confidence interval [CI] 0.846-0.994; P = 0.036), EPE (OR 0.557, 95% CI 0.810-0.987; P = 0.011), SVI (OR 0.396, 95% CI 0.798-1.038; P = 0.059), and BCR within 1 year after robot-assisted radical prostatectomy (OR 0.638, 95% CI 0.971-3.512, P = 0.046). TT was not a predictor. CONCLUSION: In contrast to popular belief, testosterone remained stable in men aged 40-80 years, whereas free testosterone decreased by 2-3%/year. Low cFT was an independent predictor of very-high-risk PCa and BCR.

Acute Ischemic Priapism: An AUA/SMSNA Guideline.

PURPOSE: Priapism is a persistent penile erection that continues hours beyond, or is unrelated to, sexual stimulation and results in a prolonged and uncontrolled erection. Given its time-dependent and progressive nature, priapism is a situation that both urologists and emergency medicine practitioners must be familiar with and comfortable managing. Acute ischemic priapism, characterized by little or no cavernous blood flow and abnormal cavernous blood gases (ie, hypoxic, hypercarbic, acidotic) represents a medical emergency and may lead to cavernosal fibrosis and subsequent erectile dysfunction. MATERIALS AND METHODS: A comprehensive search of the literature was performed by Emergency Care Research Institute for articles published between January 1, 1960 and May 1, 2020. Searches identified 2948 potentially relevant articles, and 2516 of these were excluded at the title or abstract level for not meeting inclusion criteria for any key question. Full texts for the remaining 432 articles were reviewed, and ultimately 137 unique articles were included in the report. RESULTS: This Guideline was developed to inform clinicians on the proper diagnosis and surgical and non-surgical treatment of patients with acute ischemic priapism. This Guideline addresses the role of imaging, adjunctive laboratory testing, early involvement of urologists when presenting to the emergency room, discussion of conservative therapies, enhanced data for patient counseling on risks of erectile dysfunction and surgical complications, specific recommendations on intracavernosal phenylephrine with or without irrigation, the inclusion of novel surgical techniques (eg, tunneling), and early penile prosthesis placement. CONCLUSIONS: All patients with priapism should be evaluated emergently to identify the sub-type of priapism (acute ischemic versus non-ischemic) and those with an acute ischemic event should be provided early intervention. Treatment of the acute ischemic patient must be based on patient objectives, available resources, and clinician experience. As such, a single pathway for managing the condition is oversimplified and no longer appropriate. Using a diversified approach, some men may be treated with intracavernosal injections of phenylephrine alone, others with aspiration/irrigation or distal shunting, and some may undergo non-emergent placement of a penile prosthesis.

Does Medicaid Cover Penile Prosthesis Surgery? A State-by-State Analysis.

BACKGROUND: Malleable [MPP] and inflatable [IPP] penile prosthesis surgery for the management of erectile dysfunction is a reliable treatment option with high success rates and excellent patient satisfaction; however, Medicaid coverage transparency is poor leaving a knowledge gap in this population. AIM: The present study seeks to assess Medicaid coverage for MPP and IPP by state as evidenced by inclusion in publicly available physician fee schedules. METHODS: State Medicaid websites were utilized to access public physician fee schedules. Individual search queries were performed for CPT codes 54400 and 54405 which represent insertion of MPP and IPP, respectively. Data were recorded for each device, including the coverage status, physician fees, and the presence of clear documentation of a prior authorization requirement. OUTCOMES: Medicaid physician fee schedules were accessible for 49 out of 50 US states, and 28 states reported coverage for at least one type of penile prosthesis. RESULTS: Two states reported coverage for MPP only, one state reported coverage for IPP only, and 24 states reported coverage for both devices. One state reported that it did not cover either device, but listed coverage for a self-contained IPP (CPT 54401) only. Mean physician reimbursement was $477.15 (290.82-$1175.50) for MPP placement and $691.76 (421.68-$1794.27) for IPP. Eleven states documented prior authorization requirements within their fee schedules, while the remaining 17 states did not. Criteria for approval for prior authorization were not clearly stated in any fee schedule. CLINICAL IMPLICATIONS: Efforts to clearly document approval criteria and educate Men's Health providers on available coverage could result in a significant improvement in sexual satisfaction in the Medicaid population. STRENGTHS AND LIMITATIONS: Graphical representation of states offering Medicaid penile prosthetic coverage and physician reimbursement ranges are provided with comparison to Medicare rates. Limitations include heterogeneity in fee schedules, lack of prior authorization requirement details, inability to correlate to successful claims data, and the evolving nature of Medicaid coverage for the given procedures. CONCLUSIONS: Medicaid coverage exists for penile prosthetic surgery in 28 states, although often with significant, non-transparent prior authorization criteria. Barnard JT, Grimaud L, Yafi FA. Does Medicaid Cover Penile Prosthesis Surgery? A State-by-State Analysis. J Sex Med 2021;18:1455-1460.

Technological Advances in Penile Implant Surgery.

BACKGROUND: During the last century, surgical management of erectile dysfunction has evolved from an experimental concept to a core treatment modality with widespread use among the men's health community. Over time, innovations in materials, mechanical design elements, device coatings, and surgical technique have provided patients with low-risk, reliable, and reproducible erectile function with high satisfaction rates. AIM: To provide a foundation for future innovation by improving understanding of historical penile prosthetics and the rationale behind incremental technological improvements for the contemporary Men's Health physician. METHODS: Literature review was conducted to generate a comprehensive review of historical technological innovations in penile implant surgery. Companies with FDA approved penile prosthetics in use in the United States were contacted for information regarding technological innovations in the past and future devices in development. A separate literature review was performed to identify any significant future device design elements being tested, even in the ex vivo setting, which may have future clinical applications. OUTCOMES: Technological innovations in penile implant surgery were described. RESULTS: Current options for the prosthetic surgeon include malleable penile prostheses (MPP), self-contained (2-piece) inflatable penile prostheses, and multicomponent (3-piece) inflatable penile prostheses. Current MPPs consist of a synthetic coated solid core which allow for manipulation of the penis for concealability while maintaining sufficient axial rigidity to achieve penetration when desired. Multi-component (3-Piece) IPPs currently include the Coloplast Titan and Boston Scientific/AMS 700 which consist of a fluid reservoir, intrascrotal pump, and intracavernosal cylinders. The devices have undergone numerous design updates to the cylinders, pump, reservoir, tubing, and external coatings to increase reliability and decrease short- and long-term complications. CLINICAL IMPLICATIONS: Future innovations in penile prosthetic surgery seek to broaden the indications and applicability to the transgender community and improve both safety and functionality for patient and partner. STRENGTHS & LIMITATIONS: The review is limited primarily to penile prosthetics approved for current or historical clinical use in the United States and may not be representative of the global prosthetic environment. Additionally, the research and development of future innovations, particularly those provided by device manufacturers, is likely limited by non-disclosure to maintain a competitive advantage. CONCLUSIONS: Penile prosthetic surgery will undoubtedly remain integral to the treatment of erectile dysfunction, and education regarding the current state of technological innovation will empower the prosthetic surgeon and biomedical engineering community to improve contemporary patient care and drive the development of the next generation of implantable penile prosthetics. Barnard JT, Cakir OO, Ralph D, et al. Technological Advances in Penile Implant Surgery. J Sex Med 2021;18:1158-1166.

Comparing and Contrasting Peyronie's Disease Guidelines: Points of Consensus and Deviation.

BACKGROUND: Peyronie's disease (PD) is a challenging clinical entity. To assist clinicians with diagnosis and management, four separate organizations have published PD guidelines over the past five years, but there remains a lack of consensus and data-driven recommendations for many aspects of diagnosis and treatment. AIM: To compare and contrast PD guidelines, highlighting key similarities and differences among the guideline panel recommendations and identify areas for further research. METHODS: We performed an extensive review to compare and contrast diagnosis and treatment recommendations from publically available published PD guidelines from four different organizations: American Urological Association, European Association of Urology, Canadian Urologic Association, and the International Society of Sexual Medicine. OUTCOMES: Key similarities and differences with regards to definition, evaluation, nonsurgical and surgical treatments were compared. RESULTS: Points of general consensus among the guideline panels included: History is adequate for diagnosis of PD, and intracavernosal injection is a gold standard to evaluate penile deformity prior to invasive intervention. Careful counseling with shared decision-making is required prior to treatment. In general, plication and incision and/or grafting surgery is reserved for patients with preserved erectile function whereas penile prosthesis implantation is the only surgical option for PD patients with erectile dysfunction. Overall, nonsurgical treatments have inferior evidence of efficacy with these being the main area of controversy; however, all societies recognize that intralesional injections may be used. 0Further research into the pathophysiology of PD may direct novel treatments targeted towards early intervention and rigorous outcomes research may direct best practices for the surgical treatment of PD in the future. CLINICAL IMPLICATIONS: PD is a challenging clinical entity. Direct comparison of the published PD guidelines highlights clear standards of care as well as areas where more research is needed to promote higher levels of evidence-based practice. STRENGTHS & LIMITATIONS: To our knowledge this is the first report to directly compare and contrast published guidelines pertaining to the diagnosis and management of PD. Limitations include the lack of evidence-quality review pertaining to individual guideline recommendations, although this was not the aim of this review. CONCLUSION: We highlight consensus of major urologic societies on many aspects of work up and management of PD with notable exceptions which may guide further research. Manka MG, White LA, Yafi FA, et al. Comparing and Contrasting Peyronie's Disease Guidelines: Points of Consensus and Deviation. J Sex Med 2021;18:363-375.

Development and Validation of the Satisfaction Survey for Inflatable Penile Implant (SSIPI).

BACKGROUND: No validated English language patient-reported outcome (PRO) currently exists that assesses satisfaction with inflatable penile prosthesis (IPP). Satisfaction data have been largely based primarily on surgeon assessment of patients or using questionnaires that have not been designed for this purpose. AIM: To develop an English-language validated PRO that assesses patient satisfaction after IPP surgery. METHODS: Initially, a literature review and discussions with experts defined domains important to IPP satisfaction (pain, appearance, function, overall satisfaction). The initial 35-item Satisfaction Survey for Inflatable Penile Implant (SSIPI) was developed. Cognitive interviews were then performed with IPP patients (n = 12) to gain feedback on the SSIPI domains and items. These data were used to modify SSIPI with the addition of 2 questions for a final item number of 37. Patients from 4 centers, who were between 6 months and 5 years after IPP, were administered the questionnaire through RedCap. Reliability statistics and content analysis were used to winnow questions to yield the final 16-item version of the SSIPI. Internal consistency was assessed via Cronbach's alpha and item-total correlation. Test-retest reliability was assessed via intraclass correlation coefficients using baseline and 2-week data. For convergent validity, the Erectile Dysfunction Inventory of Treatment Satisfaction and the Self-Esteem and Relationship (SEAR) questionnaire were used. For discriminant validity, the International Prostate Symptom Score (IPSS) was used. Confirmatory factor analysis was used to assess the factor structure of the SSIPI. OUTCOMES: Internal consistency, test-retest reliability, convergent and discriminant validity, and confirmatory factor analysis were assessed. RESULTS: 118 men were surveyed. Mean age was 66.8 ± 9.5 years. The 16-item SSIPI showed high internal consistency with an overall Cronbach's Alpha of 0.97 (domains 0.85-0.89). Item-total correlations for individual items to subscales ranged from 0.60 to 0.91. The overall test-retest reliability was 0.94 (domains 0.87-0.93). Erectile Dysfunction Inventory of Treatment Satisfaction and Self-Esteem and Relationship had correlations of 0.84 overall (domains 0.57-0.79) and 0.47 overall (domains 0.34-0.44), respectively. International Prostate Symptom Score (discriminant validity) had correlations of -0.29 overall (domains -0.17 to -0.31). CLINICAL IMPLICATIONS: SSIPI is the first English-language validated IPP satisfaction PRO. This will enable clinicians to collect satisfaction data in a standardized way. STRENGTHS AND LIMITATIONS: As strengths we have used a rigorous psychometric process and have no industry sponsorship. Limitations include small numbers of specific subpopulations. CONCLUSION: The SSIPI has demonstrated robust psychometric properties. Salter CA, Bach PV, Jenkins L, et al. Development and Validation of the Satisfaction Survey for Inflatable Penile Implant (SSIPI). J Sex Med 2021;18:1641-1651.

A Multicenter Investigation Examining American Urological Association Recommended Antibiotic Prophylaxis vs Nonstandard Prophylaxis in Preventing Device Infections in Penile Prosthesis Surgery in Diabetic Patients.

PURPOSE: American Urological Association (AUA) antibiotic prophylaxis recommendations may be insufficient for covering organisms commonly found in penile prosthesis infections. In this study we assess the difference between AUA recommended antibiotic prophylaxis and nonstandard prophylaxis in preventing device infections in penile prosthesis surgery performed in diabetic patients. MATERIALS AND METHODS: A multicenter, retrospective cohort study of diabetic patients undergoing primary penile prosthesis surgery was performed between April 2003 and August 2018. Eighteen institutions from the United States, Europe and Korea contributed. The association between antibiotic prophylaxis type and postoperative penile prosthesis infections, device explantations and revision surgeries was assessed. RESULTS: Standard AUA antibiotic prophylaxis was followed in 48.6% (391) of cases while nonstandard prophylaxis was used in 51.4% (413). Common nonstandard antibiotic prophylaxis included vancomycin-gentamycin-fluoroquinolone, clindamycin-fluoroquinolone, and vancomycin-fluoroquinolone among other combinations. Patients who received AUA prophylaxis had significantly more postoperative device infections (5.6% vs 1.9%, p <0.01) and explantations (8.3% vs 2.0%, p <0.001) compared to those who received nonstandard prophylaxis. Patients who received AUA prophylaxis had significantly higher odds of a postoperative device infection (OR 2.8, 95% CI 1.1-7.3) and explantation (OR 3.6, 95% CI 1.4-9.1) compared to those who received nonstandard prophylaxis. CONCLUSIONS: Diabetic men with erectile dysfunction who received standard AUA prophylaxis for penile prosthesis surgery had significantly greater odds of experiencing a postoperative device infection and device explantation compared to patients who received nonstandard prophylaxis. Our study provides a strong rationale for a prospective investigation to establish the most appropriate prophylaxis strategy in penile prosthesis surgery.

Inflatable penile prosthesis implantation into scarred corporal bodies: timing may decrease postoperative problems.

OBJECTIVES: To compare the rates of intra- and postoperative complications between early (<4 months) or delayed (>4 months) inflatable penile prosthesis (IPP) re-implantation performed after a fibrosis-inducing event. PATIENTS AND METHODS: Cases of IPP re-implantation were performed by a single, high-volume prosthetic surgeon in hospitals domestically and abroad over a 15-year period (2001-2016). The time interval from the precipitating event to operation, intra-operative complications and postoperative complications for up to 1 year after implantation, were recorded. RESULTS: A total of 72 cases of IPP re-implantation were recorded. There were 16 (53%) intraoperative complications in patients who had surgery at <4 months (Group 1) and 23 (55%) in patients operated at >4 months (Group 2). There were four (13%) postoperative complications in Group 1 and 14 (33%) in Group 2. CONCLUSION: Re-implantation of an IPP into fibrotic corporal bodies is associated with less serious postoperative complications when performed within 4 months of the fibrosis-inducing event.

Testosterone replacement therapy reduces biochemical recurrence after radical prostatectomy.

OBJECTIVE: To evaluate risk of prostate cancer biochemical recurrence (BCR) after radical prostatectomy (RP) in men receiving vs not receiving testosterone replacement therapy (TRT). PATIENTS AND METHODS: A total of 850 patients underwent RP by a single surgeon. All patients had preoperative testosterone and sex hormone-binding globulin levels determined; free testosterone was calculated prospectively. In all, 152 (18%) patients with low preoperative calculated free testosterone (cFT) levels and delayed postoperative sexual function recovery were placed on TRT and proportionately matched to 419 control patients by pathological Gleason Grade Group (GGG) and stage. Rates and time to BCR [two consecutive prostate-specific antigen (PSA) levels of ≥0.2 ng/mL] were compared in univariate and multivariate regression; Cox regression was used to generate a survival function at the mean of covariates. RESULTS: The median follow-up was 3.5 years. There were no statistically significant differences in demographics or general health complications between groups. BCR occurred in 11/152 (7.2%) and 53/419 (12.6%) patients in the TRT and control groups, respectively. In adjusted time-to-event analysis, TRT was an independent predictor of recurrence-free survival. After accounting for GGG, pathological stage, preoperative PSA level, and cFT, patients on TRT were ~54% less likely to recur (hazard ratio 0.54, 95% confidence interval 0.292-0.997). In men destined to recur, TRT delayed time to recurrence by an average of 1.5 years. CONCLUSION: In our experience, TRT after RP significantly reduced BCR and delayed time to BCR. There was no identifiable general health complications associated with TRT. These findings are hypothesis-generating and require confirmation with multi-centred, prospective randomised controlled trials.

Favourable multi-institutional experience with penoscrotal decompression for prolonged ischaemic priapism.

OBJECTIVES: To report our multi-institutional experience using penoscrotal decompression (PSD) for the surgical treatment of prolonged ischaemic priapism (PIP). MATERIALS AND METHODS: We retrospectively reviewed clinical records for patients with PIP treated with PSD between 2017 and 2020. Priapisms were confirmed as ischaemic based on clinical presentations and cavernosal blood gas abnormalities. Treatment with irrigation and injection of α-agonists in all patients had failed prior to PSD. Patient characteristics, peri-operative variables and outcomes, and changes in International Index of Erectile Function (IIEF) scores were evaluated. RESULTS: We analysed 25 patients who underwent a total of 27 PSD procedures. The mean duration of priapism at initial presentation was 71.0 h. Irrigations and injections in all patients had failed, while corporoglanular shunt treatment in 48.0% of patients (12/25) had also failed prior to PSD. Of the 10 patients who underwent unilateral PSD, two (20.0%) had priapism recurrence. Both were treated with bilateral PSD, with prompt and lasting detumescence. Among the 15 patients undergoing primary bilateral PSD, none had priapism recurrence. Of the 15 patients with documented sexual function status at last follow-up, nine (60%) reported spontaneous erectile function adequate for penetration, while six (40%) reported erectile dysfunction. The median (interquartile range) decrease in IIEF-5 score was 3.5 (0-6.75) points after PSD. Two patients underwent uneventful inflatable penile prosthesis placement following PSD. CONCLUSIONS: Penoscrotal decompression presents a simple, safe, highly effective and easily reproducible procedure for resolution of PIP. PSD should be considered as a viable salvage or alternative strategy to corporoglanular shunt procedures.

What Is a "Validated Questionnaire"? A Critical Review of Erectile Function Assessment.

BACKGROUND: In recent years, the assessment of erectile dysfunction (ED) has experienced a paradigm shift from objective, quantitative methods to subjective, qualitative patient-reported outcomes. Facilitated by this shift is the ongoing debate on questionnaire selection and need for standardization, particularly among sexual medicine specialists. AIM: To review current literature on assessment of erectile function via patient-reported outcomes and discuss the context, advantages, and limitations of currently available questionnaires. METHODS: A thorough literature search of erectile function questionnaires developed from 1990 through 2019 was carried out using 3 methods: a search of the MedLine databases; hand-search of peer-reviewed urologic, sexual medicine, and health policy journals; and expert review. The following keywords were used: [assessment of], [inventory], [questionnaire], or [validated measure]; in combination with: [sexual function] or [erectile function]. Measures were stratified into one of the following 3 groups: screening, outcome, or disease-specific. 3 screening measures (International Index of Erectile Function, the Male Sexual Health Questionnaire, and Brief Male Sexual Inventory); 5 outcome measures (Sexual Health Inventory for Men, Erection Hardness Score, Erectile Dysfunction Inventory for Treatment and Satisfaction, and Treatment Satisfaction Scale); and 3 categories of disease-specific measures (cancer, Peyronie's disease, and spinal cord injury) were included. OUTCOMES: Strengths, limitations, and valid uses of each erectile function questionnaire. RESULTS: There currently exists a wide variety of screening, outcome, and disease-specific measures for ED diagnosis, assessment, and treatment. Rigor of psychometric validation varies greatly across studies. However, depending on purpose of use, all abovementioned questionnaires have merit for use in clinical practice, are nonredundant, and can complement and supplement one another. CLINICAL IMPLICATIONS: Before choosing a specific measure for ED diagnosis, assessment, or treatment, there must be careful consideration of the questionnaire's psychometric properties, context of validation, and its possible limitations. STRENGTHS & LIMITATIONS: The patient reported outcome measures highlighted in this article complement and supplement one another, as each emphasizes a related yet distinct central theme. During selection for use in clinical practice and research studies, special attention needs to be paid to the context, strengths, and weaknesses of each measure. CONCLUSION: When used conscientiously, patient-reported questionnaires can significantly optimize patient management. Yafi FA, Huynh LM, Ahlering T, et al. What Is a "Validated Questionnaire"? A Critical Review of Erectile Function Assessment. J Sex Med 2020;17:849-860.

A Multi-institutional Assessment of Multimodal Analgesia in Penile Implant Recipients Demonstrates Dramatic Reduction in Pain Scores and Narcotic Usage.

INTRODUCTION: Despite the pain associated with inflatable penile prosthesis (IPP) implantation, there has been a lack of standardized, nonopioid pain control regimens described to date. AIM: To assess the effectiveness of a multimodal analgesic regimen in patients undergoing implantation of an IPP compared with patients treated with an opioid-only regimen. METHODS: A large, multicenter patient cohort undergoing IPP implantation whose pain was managed using a multimodal analgesia (MMA) protocol (preoperative and postoperative acetaminophen, meloxicam orcelecoxib, and gabapentin and intraoperative dorsal and pudendal nerve blocks) was compared with a matched cohort of patients managed via an opioid-only protocol. Both groups were compared with respect to visual analog score (VAS) and opioid usage (total morphine equivalents [TME]) in the post-anesthesia care unit (PACU), postoperative day 0 (POD0) and postoperative day 1 (POD1), and in the immediate postdischarge period. Narcotic usage on discharge and follow-up were assessed and compared. MAIN OUTCOME MEASURE: Postoperative pain scores and narcotic usage are the main outcome measures. RESULTS: 203 patients were eligible for final analysis: 103 (50.7%) patients receiving MMA medication and 100 (49.3%) patients receiving opioids only. The VAS was significantly lower in the multimodal group in PACU (median 0.0 vs 2.0, P = .001), POD0 (median 3.0 vs 4.0, P = .001), and POD1 (median 3.0 vs 4.3, P = .04). Patients in the multimodal group also used fewer narcotics in PACU (median 0.0 vs 4.0 TME, P = .001), POD0 (median 7.5 vs 12.5 TME, P < .001), and POD1 (median 7.5 vs 13.5 TME, P = .01). Despite being discharged with fewer narcotics (median 20.0 vs 30.0 tablets, P < .001), a smaller proportion of patients in the MMA cohort required narcotic refills (10.7% vs 28.0%, P = .001). There were no narcotic- or MMA medication-related side effects in the entire cohort. CLINICAL IMPLICATIONS: MMA confers significant improvement in pain management while also providing a significant reduction in narcotic usage in patients undergoing implantation of IPP. STRENGTH & LIMITATIONS: This is the 1st large multi-institutional assessment of a multimodal analgesic regimen in urologic prosthetic surgery. The analgesic regimen targets several pain pathways that provide excellent pain control throughout the recovery process. Limitations include retrospective design and lack of standardization of the nonsteroidal anti-inflammatory drug type within the multimodal analgesic regimen. CONCLUSION: The use of a MMA protocol significantly reduces postoperative pain measures in penile implant recipients and further reduces both inpatient and outpatient narcotic usage without any discernable side effects. Lucas J, Gross M, Yafi F, et al. A Multi-institutional Assessment of Multimodal Analgesia in Penile Implant Recipients Demonstrates Dramatic Reduction in Pain Scores and Narcotic Usage. J Sex Med 2020;17:518-525.