Ziegelmann, Matthew

Abstract Introduction Down-sized inflatable penile prosthesis (IPP) cylinders are used in challenging penile fibrosis scenarios, such as after priapism or prior implant infection. Their role in primary penile prosthesis surgery, however, is not well studied. Objective This study aims to identify factors associated with the use of down-sized cylinders in men undergoing primary IPP placement. Methods We conducted a multicenter, retrospective study on men undergoing primary IPP surgery, categorizing them into a down-sized cylinder group (AMS 700 CXR and Coloplast NB) and a standard cylinder group (AMS 700 CX, AMS 700 LGX, and Coloplast Titan). We collected demographic, intraoperative, and postoperative variables and performed a multivariable analysis. Results 4,389 men were included in the study with a mean age of 62.3±10.3 years. Overall, 1,485 (34%) men had diabetes, and 2,131 (49%) had hypertension. Down-sized cylinders were placed in 406 men (174 CXRs, 232 NBs), while standard cylinders were placed in 3,983. Multivariable analysis indicated that down-sized cylinders were more commonly used in men with diabetes (OR 2.6 [1.9, 3.7], p<0.001) and less frequently in men with hypertension (OR 0.5 [0.4, 0.7], p<0.001). A history of priapism did not significantly impact the use of down-sized cylinders (p≥0.152). Sequential dilation was performed more often with the use of down-sized cylinders (OR 4.0 [2.8, 5.7], p<0.001). Down-sized cylinders were associated with an increased rate of non-infectious complications (OR 1.9 [1.3, 2.9], p<0.001), however, there was no significant association with implant infection (OR 2.1 [0.9, 4.6], p=0.07). Non-infectious complications occurred in 44 (25%) men with down-sized cylinders. In the down-sized group, hematomas occurred in 10 (2.5%) men and wound-related complications occurred in 7 (1.7%) men (Table 1). Cylinder-related complications occurred in 7 (1.7%) men with down-sized cylinders. Device-related malfunctions were seen in 8 (2%) men. Conclusions This study demonstrates that down-sized cylinders are more frequently used in men with diabetes and surgeons should be prepared to place down-sized cylinders in these men. Prosthetic urologists are also more likely to use down-sized cylinders in men requiring sequential dilation likely due to fibrosis or more challenging dilations. Down-sized cylinders are associated with a low overall complication rate. 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 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 Introduction Proximal perforation in complex penile prosthesis placement is well recognized. If recognized, suture sling repair amongst other techniques is our favored approach. Unrecognized proximal perforation often results in unilateral or bilateral perineal bruising, often with eventual proximal device migration and palpability of the proximal device in the buttock. Objective We present a series of 5 cases in which the suture sling technique was utilized for known proximal perforation, with subsequent need for immediate or delayed revision. Methods We assessed all cases performed at Mayo Clinic since 2018 that resulted in a known suture sling complication amongst 3 high volume implanters. We identified 5 cases in which the suture sling technique required revision surgery. All patients underwent cross sectional imaging for further evaluation. Results Patients were males aged 59 to 89 with erectile dysfunction. There were no consistent factors amongst the 5 cases that may have predicted suture sling complication. The majority of cases were inflatable penile prostheses (4/5), were prosthesis revision cases (3/5), utilized the penoscrotal approach (4/5), were Coloplast devices (4/5), utilized rear tip extenders (3/5), utilized Prolene suture sling (3/5), and returned to OR within 2 days for revision (3/5). The majority of the complications (4/5) involved excessive proximal cylinder length that were palpable on examination of the buttocks or near the rectum (one felt on rectal exam). One case demonstrated improper anchoring of the device not allowing proximal seating and thus S shaped deformity. We noted medial cylinder deviation on all imaging, as corporal perforation was always medial to the true corporal path. Conclusions When performing suture slings, surgeons should be very wary of oversizing. The medial cylinder path and prior surgical capsule may mislead surgeons when choosing appropriate cylinder length. If perforated, we advocate against rear tips and for under sizing in general, as proximal anchoring is reliant upon the suture, not a true corporal boundary. Similarly, the device should be fully inflated and proximally seated on palpation prior to tying down the sling to avoid S deformities. Disclosure No

Abstract Introduction Glans ischemia and subsequent necrosis is a rare but devastating complication of inflatable penile prosthesis (IPP) placement. Differentiating true glans ischemia from severe ecchymosis can be difficult but is critical, particularly in light of the adage, “when in doubt, take it out.” However, post-operative glans discoloration can be misleading and result in premature device explantation. Objective To present clinical cases and identify distinguishing features between true glans ischemia and pronounced post-operative ecchymosis, with emphasis on risk factors and evaluation techniques. Methods A retrospective case series was conducted on four IPP patients in 2025 who presented with significant glans discoloration concerning for ischemia. Key operative variables, physical exam findings, and postoperative images were reviewed. Additionally, a prospective database of 298 implants placed under local anesthesia since 2024 was analyzed for glans bruising severity on postoperative day (POD) 3, using a 0–4 scale. Results Common ischemia risk factors included tight circumferential wrap (e.g., Coban), vasculopathy (e.g., prior arterial bypass), prolonged catheterization, and concomitant procedures. Case 1: History of pelvic radiation with ecchymotic meatus and glans. Improved after wrap removal and better lighting. Case 2: Extensive ecchymosis and discoloration of glans and scrotum noted on POD1 after uneventful IPP under local. Case 3: Patchy glans discoloration after multiple Keith needle passes. Skin tone complicated assessment. Case 4: Severe glans bruising immediately post-op following multiple needle passes due to suture breakage. In all cases, the glans was warm, well-perfused, and not painful out of proportion to appearance. No patients required explantation. Glans bruising rates in 298 implants under local anesthesia were: 0 (3.7%), 1 (48.7%), 2 (25.5%), 3 (21.1%), 4 (0.3%), notably higher than with general anesthesia. Key Clinical Indicators: Favors Hematoma: • Vascular corpora • Small/no catheter • Bruising elsewhere • Wrap excluded glans • No blistering • No paresthesias • Glans warm to touch Favors Ischemia: • Avascular corpora • Large indwelling catheter • Minimal bruising elsewhere • Coban wrap on shaft • Blistering present • Pain or paresthesias • Glans cold to touch Conclusions Significant glans bruising can mimic ischemia, particularly in IPPs placed under local anesthesia. Factors such as multiple Keith needle passes, tight wrapping, and poor photographic lighting may contribute to this diagnostic confusion. Warm, non-painful glans with widespread ecchymosis are reassuring. Avoiding premature explantation requires thorough clinical assessment, device unwrapping, and close patient monitoring. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: UroFill, Coloplast, Boston Scientific, Rigicon

Abstract Introduction While most patients with Peyronie’s disease (PD) present with dorsal or lateral curvature, a significant number have ventral curvature (VC). These patients face limited treatment options, as they were excluded from initial clinical trials of collagenase clostridium histolyticum (CCH) due to safety concerns related to the proximity of the injection site to the urethra. However, urethral involvement is rare, as PD plaques develop in the tunica albuginea rather than the corpus spongiosum surrounding the urethra. Moreover, multiple prospective and retrospective studies have demonstrated favorable outcomes with CCH treatment in men with VC. Objective To evaluate the effectiveness and safety of CCH in men with PD and VC in a multicenter, real-world, retrospective study. Methods This is an ongoing phase 4, multicenter, retrospective review of medical records from 15 US physician sites. Eligible patients consisted of patients who are: age ≥18 years with a diagnosis of VC in PD with a palpable plaque that was treated with CCH from 2014 to the study start date at each site. Patients missing baseline (BL; pretreatment) or final (last measurement within 6 months of final CCH treatment) penile curvature measurements were excluded. Effectiveness endpoints included percentage change in VC from BL to last visit, mean change in VC (in degrees) from BL to last visit, and proportion of patients with ≥30% improvement in VC from BL to last visit. Safety was assessed as proportions of patients reporting treatment-related adverse events (TRAEs) throughout the study period. Results As of April 22, 2025, there were 116 patients with mean (SD) age of 58 (10.3) years who were eligible for analysis. Mean baseline VC decreased from 58 degrees to 37 degrees at last visit (37% improvement). An improvement in VC of ≥30% was seen in 73/116 (63%) of patients, with 81/116 (69.8%) experiencing ≥20% improvement. At least 1 TRAE was reported by 12 (10%) patients. TRAEs were mild-to-moderate in severity in 9 (75%) patients and unknown in 3 patients, with most events (14/17 [82%]) related to injection site reactions. As of the data cut, there were no treatment-related serious or treatment-related severe AEs, no reports of urethral involvement or injury, and no reports of corporal rupture. Conclusions Men with PD who present with ventral curvature represent an underserved patient population. Concerns about potential urethral injury pose a significant barrier to both minimally invasive and surgical treatments, thereby limiting available therapeutic options. These updated results from a multi-institutional real-world clinical cohort align with previous findings, and demonstrate that the clinical effectiveness and safety profile of CCH is consistent with the profile of CCH seen in other clinical presentations of PD. Disclosure Yes, this is sponsored by industry/sponsor: Endo USA, Inc Clarification: Industry initiated, executed and funded study Any of the authors act as a consultant, employee or shareholder of an industry for: Endo USA, Inc.