Trost, Landon

ABSTRACT Introduction The significant overlap of risk factors for erectile dysfunction and venous thromboembolism (VTE) may disproportionally increase the risk of VTE in men undergoing inflatable penile prosthesis (IPP) surgery. Owing to the absence of available literature, AUA and EAU perioperative VTE guidelines do not address VTE risk with IPP surgery and generally recommend against pharmacologic prophylaxis with outpatient surgery. The Caprini Score is a validated scoring system to estimate VTE risk in the perioperative period. Objective We sought to assess the risk of VTE by calculating Caprini Scores in men undergoing IPP surgery. Methods We retrospectively reviewed and calculated Caprini Scores for patients undergoing IPP surgery at our institution between July 2017 and June 2019. Results 215 patients undergoing IPP surgery were identified with a mean and median Caprini score of 5.96 (SD, 1.63) and 6 (IQR 5,7), respectively. 84% of the cohort was classified as high or highest risk for VTE (Figure 1). This is in part due to our cohort's mean age of 64, mean BMI of 31 and history of prostate cancer treatment as the cause of ED. Prior history of VTE (deep vein thrombosis(DVT) or pulmonary embolism (PE)was identified in 17 (8%) patients with 5 (2%) have a history of both DVT and PE. Conclusions Men undergoing IPP surgery are high risk for VTE based on Caprini score assessment. VTE prophylaxis should be considered in men undergoing penile implant surgery. Before widespread application, long-term data is necessary to assess safety and efficacy of VTE prophylaxis in the IPP surgery population. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Senior author consultant for Coloplast

ABSTRACT Introduction IPP revision after implant malfunction yields rare insight into patient preference and perception of penile implant variations in brand and size. Objective To assess patients’ perception of their penile implant after IPP revision. Methods Retrospective review of all patients undergoing revision surgery for purely mechanical malfunction (fluid leak) at our institution since 2017. Patients with greater than 6 months follow-up after revision were contacted to comment on changes in penile size and device preference. Patients were asked 1. “Did you notice any change in penile length or girth after your last surgery, explain, and 2. “Please describe your preference (if any) of implant and why”. We utilize the Coloplast Titan with “classic” (genesis) pump in most cases, with AMS Cx cylinders being used in cases with attenuated corpora (aneurysm). Results 21 patients were identified that met criteria with an average age of 70. 15/21 were successfully contacted. 9 Coloplast, 2 Mentor, and 12 AMS devices (Cx =7, LGX =4, Ultrex =1) were revised. Device brand used to replace the broken IPP was n= 19 for Coloplast and n=3 for AMS (Cx =2, Lgx =1). Mean and median time to revision was 9 years overall (2-26) and was similar between Coloplast and AMS. Fluid leak location showed no discernable pattern. Total average implant length increased 2.2 cm from 20.6 cm to 22.8 cm. 8/10 patients were reached that had had both AMS and Coloplast devices (all AMS initially). 12 patients stayed within the manufacturer. Despite change in implanted length, most patients did not discern a definitive change in penile length unless cylinders increased by > 3 cm (perhaps reflecting under-sizing of initial implant). All patients correctly described improvement or no change in penile girth when compared to actual cylinder sizes. Patients preferred Coloplast (6 – girth/erection quality/pump), AMS (1 pump/flaccidity) and undecided (1). Several patients felt consistently cycling the device after revision led to relative length improvement and ease of use. Conclusions Our small cohort of IPP revision patients for mechanical failure reveals that revision often requires longer cylinders but this is often imperceptible to the patient. Increased cylinder girth was a key factor in driving device preference. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Senior author consultant for Coloplast

Abstract Introduction Current non-invasive treatments for erectile dysfunction (ED) include oral medications, intracavernosal injections, and vacuum-assisted devices. Though these therapies work well for many, a subset of patients have contraindications or are unsatisfied with these options. Restorative therapies for ED are a new frontier of treatments focused on regenerating diseased tissue and providing a potential “cure” for ED. Aim The aim of this position statement is to examine existing clinical trial data for restorative therapies and identify elements that require further research before widespread adoption. Methods A literature review was performed to identify all clinical trials performed with regenerative therapy for ED. This includes treatments such as stem cell therapy (SCT), platelet rich plasma (PRP), and restorative related technologies like low-intensity shockwave therapy (LiSWT). Main Outcome Measures Most clinical trials in restorative therapies were assessed for safety, feasibility, or efficacy. This included recording adverse events, changes in sexual function and erectile function questionnaires, and diagnostics measures. Results To date there is an absence of robust clinical data supporting the efficacy of restorative therapies regarding ED, though technologies such as LiSWT have established relative safety. Conclusions Restorative therapies are a promising technology that represents a new frontier of treatment geared towards reversing disease pathology rather than just treating symptoms. However, current published clinical studies are limited. Future work needs to be adequately powered, multi-center, randomized, sham/placebo-controlled trials in well-characterized patient populations to ensure safety and demonstrate efficacy. Until these studies are done, restorative therapies should be reserved for clinical trials and not offered in routine clinical practice.

Abstract Introduction Treatments for Peyronie's disease (PD) include surgical management and collagenase clostridium histolyticum (CCH). Aims To evaluate PD treatment trends after CCH approval and compare clinical outcomes in CCH- and surgery-treated cohorts. Methods Patients newly diagnosed with PD between January 2011 and December 2017 were identified in a U.S. claims database. Cohorts initiating treatment with CCH or surgery between January 2014 and June 2017 were included. Patients were continuously enrolled ≥6 months before and ≥12 months after index date. Post-treatment penile complications and analgesic use were compared 1 year after procedure in propensity score-matched cohorts. Main outcome measures The main outcome measures of this study were treatment patterns, penile complications, and analgesic use. Results In the newly diagnosed PD cohort, 1,609 patients received CCH and 1,555 patients had surgery. Overall CCH or surgery treatment rate/year increased from 9.8% in 2014 to 15.5% in 2017, with <1% receiving verapamil or interferon. Initial treatment ratios of CCH to surgery increased from approximately 1:1 (2014) to 2:1 (2017). In the unmatched CCH (n = 1,227) and surgery (n = 620) cohorts, more (P < .05) surgery-treated patients received analgesics (particularly opioids), oral PD therapies, vacuum erection devices, and phosphodiesterase-5 inhibitors before the index date. After propensity score matching (n = 620/cohort), newly occurring postprocedural complications during the follow-up period were higher in the surgery cohort (25.3% vs 18.4%, P = .003). The surgery cohort had significantly (P < .05) higher rates of erectile dysfunction (65.0% vs 44.8%), penile pain (17.9% vs 8.9%), and penile swelling (8.1% vs 5.2%) and was more likely to be prescribed opioids (93.3% vs 38.9%; P < .0001) or non-steroidal anti-inflammatory drugs (27.0% vs 20.3%; P = .006). Conclusion CCH demonstrated fewer complications and less analgesic use than surgery and was used as the initial therapy for PD twice as often as surgery.

Abstract Peyronie's disease (PD) is associated with significant psychosocial distress, including anxiety, depression, and negative effects on interpersonal relationships. We report outcomes in a patient who researched an enzymatic supplement intended for oral administration for treatment of PD and subsequently self-injected it intravascularly. The enzyme, a combination of serrapeptase and nattokinase, resulted in vascular necrosis of the upper extremity. Despite attempts to salvage the limb, he ultimately required transhumeral amputation. Although extreme, this case illustrates the potential risks of non–Food and Drug Administration–approved therapies, the significant psychosocial impact that PD can have on patients' emotional well-being, and the extent to which some may go to seek treatment. Yang D, Savage J, Kohler T, et al. Vascular Necrosis of the Upper Extremity After Self-Treatment for Peyronie's Disease. Sex Med 2021;9:100282.

Abstract Background A randomized, controlled clinical trial evaluating the efficacy of RestoreX traction therapy in men with Peyronie’s disease (PD) has been completed, with the 3-month results previously reported. The present study presents outcomes from the open-label and follow-up phases of the original trial. Aim To report 6-month (open-label phase) and 9-month (follow-up phase) outcomes from a randomized, controlled trial (NCT03389854). Methods A randomized controlled trial was performed from 2017 to 2019 in 110 all-comer men with PD. Men were randomized 3:1 to RestoreX (PTT) or no therapy (control) for 3 months, followed by 3-month open-label and follow-up phases. Key outcomes included adverse events (AEs), changes in penile curvature and length, erectile function, and standardized and nonstandardized assessments of PD. Outcomes The primary outcomes are safety, penile length, penile curvature, Peyronie’s Disease Questionnaire, International Index of Erectile Function, and satisfaction. Results 6-month (n = 64) and 9-month (n = 63) outcomes were reported, with a mean duration of PTT use of 31.1 minutes. No significant AEs were reported, with temporary erythema and discomfort being most common and resolving within minutes. On intent-to-treat analysis, control-to-PTT men experienced significant length (1.7–2.0 cm) and curvature improvements (18–20%). PTT-to-PTT men also achieved additional length (0.6–0.8 cm) without further curvature improvements. An as-treated analysis of PTT use ≥15 minute/day demonstrated 2.0- to 2.3-cm length gains (largest of any PTT to date) and 18–21% curve improvement. All sexual function domains of the International Index of Erectile Function and Peyronie’s Disease Questionnaire were significantly improved (except orgasmic domain). 95% of men treated for 6 months experienced length gains (mean 2.0–2.2 cm), and 61% had curve improvements (16.8–21.4° [32.8–35.8%]). RestoreX was preferred 3–4:1 over all other PD treatments, and 100% preferred it over other PTT devices. Clinical Implications Use of RestoreX 30 minutes daily results in significant length and curve improvements in PD men without significant AEs. Strengths & Limitations Strengths include largest randomized study of PTT, blinded assessments, and inclusion of all-comers with few restrictions; limitations include sample size that precludes comparisons between treatment cohorts and lack of long-duration (>3–9 hours) treatment arm. Conclusion PTT with RestoreX results in significant improvements in length, curve, and subjective and objective measures of sexual function without significant AEs. RestoreX PTT represents a safe, conservative, low-cost option for managing men with PD.