Helo, Sevann

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 The Penuma ® implant is a medical-grade silicone implant used in the cosmetic augmentation of the penis. Reportedly 3-11% of devices are being removed over time for reasons such as infection, pain, and dissatisfaction with the device. Objective Despite this, there remains a paucity of information demonstrating safe removal of this device. In this video, we outline intra-operative considerations to promote the safe removal of the Penuma device. Methods Sharp and blunt dissection to the level of the capsule is performed via the original incision line. The proximal end of the device is identified via sharp dissection through the capsule. The penis is then everted to expose the distal attachments of the implant, which are subsequently dissected. Superficial and sharp dissection to remove the mesh is performed. We avoid the use of cautery to prevent damage to the nearby neurovascular bundle. Once the mesh and all permanent material is removed, haemostasias is achieved. A drain may be placed. The incision is irrigated and closed in a multi-layer fashion. Results Here we demonstrate a safe and feasible method to surgically remove the Penuma (Himplant) device. Conclusions In conclusion, the Penuma ® implant is a medical-grade silicone implant used in the cosmetic augmentation of the penis that can be safely removed surgically in the event of infection, pain, or dissatisfaction with the device. Disclosure No

Abstract Introduction Traditional vasectomy reversals are performed in the operating room under general anesthesia, which poses logistical, financial, and clinical drawbacks. A shift toward office-based vasectomy reversal under local anesthesia may address these limitations. Objective To demonstrate the feasibility and technical approach of performing microsurgical vasovasostomy in an office-based setting using local anesthesia, without compromising patient comfort or surgical technique. Methods In this video we outline a step-by-step microsurgical vasovasostomy in an office-based setting. Results Office-based vasovasostomy is technically feasible in the office-based setting. Conclusions Office-based microsurgical vasovasostomy is safe, feasible, and well tolerated in the office-based setting, offering multiple patient- and provider-centered advantages. Disclosure No