Citations

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

Abstract Background 0.05% Chlorhexidine gluconate (CHG) is now commonly used as an antiseptic irrigation for inflatable penile prosthesis (IPP) surgery. Limited in vitro data suggest compatibility of 0.05% CHG with antibiotic impregnated IPP devices; however, very little clinical research exists to guide use of 0.05% CHG in this population. Aim Assess the relationship of 0.05% CHG and antibiotic impregnated IPP infection in a large multi-institutional cohort. Methods We retrospectively reviewed a multi-institutional cohort of patients who underwent antibiotic impregnated IPP implantation. We identified cases using intraoperative 0.05% CHG and an equal number of consecutive control cases without 0.05% CHG use from each center for comparison. The primary outcome was IPP infection requiring explantation. Patient demographics and surgical variables were analyzed using chi-square tests and multivariable logistic regression to identify variables associated with infection. Outcomes The primary outcome was IPP infection requiring device explanation. Results Among 14 participating institutions, 761 cases using an antibiotic impregnated IPP were analyzed. Of these, 348 (45.7%) had 0.05% CHG used during the case. Median follow-up was 4 months (interquartile range 1-12) for the 0.05% CHG group and 8 months (interquartile range 2-21) for the control group. Intraoperative 0.05% CHG utilization was not associated with antibiotic impregnated IPP infection rate (1.9% vs. 2.0%, P = .9). On multivariable analysis, prior IPP infection (OR 6.32, 95% CI 1.32-30.2, P = .021) and prior priapism (OR 10.01, 95% CI 1.18-89.7, P = .039) were associated with increased infection risk. Clinical implications The use of 0.05% CHG irrigation with antibiotic impregnated IPPs was associated with similar infection rates compared to antibiotic irrigation. Strengths and limitations Limitations include the use of a historical comparator cohort which may introduce unknown confounders, practice variation between multiple sites, shorter follow-up in the 0.05% CHG cohort, and the low incidence of IPP infection which may limit statistical power despite a large sample. The major strengths include the large, multi-institutional cohort, and the use of consecutive patients to minimize selection bias. Conclusion 0.05% CHG utilization was not associated with infection rates in antibiotic impregnated IPPs.

Abstract Introduction Down-sized inflatable penile prosthesis (IPP) cylinders are useful in cases with substantial penile fibrosis such as history of priapism or prior infection. Although down-sized IPP cylinders have a clear role in fibrotic corpora, their role in primary implant cases is unclear. Objective To identify factors associated with the use of down-sized cylinders in men undergoing primary IPP placement. Methods We conducted a retrospective analysis of 4,389 patients undergoing primary IPP placement from our multicenter database. Patients were categorized by down-sized (AMS 700 CXR, Coloplast NB) vs. standard sized cylinders (AMS 700 CX, AMS 700 LGX, Coloplast Titan). We collected demographic, intraoperative, and postoperative data. A multivariable analysis was performed to identify factors associated with use of down-sized cylinders Results A total of 4,389 men undergoing primary inflatable penile prosthesis (IPP) placement were included in the study, with a mean age of 62.3 ± 10.3 years. Among them, 1,485 (34%) had diabetes and 2,131 (49%) had hypertension. A total of 406 down-sized cylinders and 3,983 standard cylinders were implanted. Non-infectious complications occurred more frequently with the use of down-sized cylinders (odds ratio [OR] = 2.0, p < 0.001). Specifically, non-infectious complications were reported in 44 out of 185 men (23.8%) with down-sized cylinders, compared to 192 out of 2,727 men (10.9%) with standard cylinders. Cylinder complications constituted 13.9% and 13.0% of the non-infectious complications in the down-sized and standard cylinder groups, respectively. Conclusions The rate of cylinder-related complications were similar between the down-sized cylinder and standard cylinder groups. Urologists should be prepared to place down-sized cylinders during IPP placement in diabetic men and in men requiring serial dilation due to fibrosis. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Intuitive Surgical, Fidelis, Urofill, Boston Scientific, Coloplast, Cynosure, Antares Pharma, Clarus Pharmaceuticals, Acerus Pharma; Endo Pharma.

Abstract Introduction Infection following inflatable penile prosthesis (IPP) placement is an uncommon yet serious complication, and its management poses significant clinical challenges. IPP infection management strategies continue to evolve, however, multicenter and robust studies evaluating and describing current practice patterns are lacking. Objective Using a large cohort from tertiary IPP referral centers in the United States to evaluate current infection management practice patterns and to identify factors that could predict the approach to managing IPP infections. Methods We queried a retrospective 14-center multi-institutional database for patients with IPP infections between April 2017 and January 1/2025. Patients were categorized by infection management strategy, which included device explant, malleable salvage, and 3-piece IPP salvage. Patient characteristics were compared using chi-square and independent t-tests. Multinomial analysis was performed to investigate patient and perioperative factors associated with management strategy at the time of infection. Results Among 2,934 cases, 85 (2.9%) patients developed IPP infection at a median of 40 (22-78) days after IPP implantation. Infections occurred after primary IPP surgery in 59 (69%), revision in 25 (29%), and after infection salvaged with IPP in 1 (1%). Infections were managed with device explant in 32 (38%), malleable salvage in 43 (51%), and IPP salvage in 10 (12%). A significantly higher proportion of non-White patients underwent salvage (either with malleable or IPP) compared to White patients (p=0.01). Multinomial regression showed no association between patient and perioperative characteristics and infection management (p>0.05). Conclusions In this multi-institutional cohort of experienced implanters, infections were most commonly managed with malleable salvage. Patient and perioperative factors did not predict management approach, suggesting that the decision between explanation and salvage is primarily driven by individual surgeon preference. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Boston scientific

Abstract Introduction Benign prostatic hyperplasia (BPH) is an age-related condition affecting many men. Emerging evidence highlights a strong relationship between BPH, lower urinary tract symptoms (LUTS) and sexual dysfunction, including erectile dysfunction (ED), reduced sexual desire, hormonal imbalances, and ejaculatory dysfunction, warranting a comprehensive approach to diagnosis and management. Objectives This report aims to provide recommendations for identifying and managing sexual dysfunction associated with BPH and LUTS. Methods Based on guidelines from the International Consultation on Sexual Medicine, a literature review was conducted. Recommendations were graded using the Grading of Recommendations Assessment, Development and Evaluation system. Results The association between BPH, LUTS, and sexual dysfunction is significant, with ED, ejaculatory dysfunction, and hypogonadism being common complications. Lifestyle modifications, medical therapies, minimally invasive surgical therapies, prostate artery embolization, and surgeries (eg, Transurethral resection of the prostate, HoLEP, Aquablation) are among the recommended treatments. Each intervention carries varying risks of sexual dysfunction, requiring specific tailored treatment plans. Conclusions BPH/LUTS significantly affect sexual health, emphasizing the need for a multidisciplinary approach to management. Future research should refine diagnostic criteria and develop treatments that minimize sexual side effects. Enhanced education for patients and their partners could improve quality of life and coping mechanisms.