Parikh, Niki

Abstract Introduction Inflatable penile prosthesis (IPP) implantation is a common and effective surgical treatment for erectile dysfunction. However, the presence of comorbidities and the use of anti-thrombotic therapy (AT) can complicate surgical decision-making. Due to the correlation between erectile dysfunction and cardiovascular disease, the preoperative comorbidities of surgical patients are important to examine. Objective The goal of this study was to assess the outcomes of IPP implantation in men on active AT therapy compared to a non-AT therapy cohort. Methods A retrospective analysis from 2015 to 2023 was conducted using data from three high-volume implant centers. The study focused on men who underwent three-piece IPP placement. Demographics, comorbidities, secondary procedures, drain information, and complications were recorded. The three centers each have different techniques and approaches to the surgery. Center 1 utilizes a penoscrotal approach, never places a drain, and places the reservoir in an ectopic location. Center 2 utilizes an infra-pubic approach, places a drain which remains in place for 3 days, and utilizes various reservoir locations depending on patient profile. Lastly, center 3 utilizes a penoscrotal approach, places a drain with removal when output is less than 50 mL over 8 hours, and places the reservoir in an ectopic location. Outcomes were analyzed using multivariate and univariate analysis. Results A total of 210 patients on active AT therapy and 128 non-AT patients were included. The AT and non-AT groups showed significant differences in baseline comorbidities, with the AT group exhibiting higher rates of cardiovascular disease, hypertension, and thrombosis (p<0.05). Among patients on anti-thrombotic therapy, 27.6% required revision surgeries and had increased rates of ectopic reservoir placement compared to the non-AT group (p<0.001). Despite these differences, there were no statistically significant variations in overall complication rates between the two groups. Drain output was notably higher in the AT cohort on postoperative days 1 (mean 110.5 cc vs 60 cc, p<0.001) and 2 (mean 78 cc vs 20 cc, p<0.001); however, hematoma rates remained comparable between both groups (p=0.667). Importantly, neither the type of anti-thrombotic therapy nor the surgical approach used appeared to influence postoperative outcomes. Eleven patients (5.2%) experienced complications in the AT arm and 5 patients (3.9%) experienced complications in the non-AT arm (p=0.793). Conclusions IPP implantation is feasible and safe in men on active anti-thrombotic therapy when performed in high-volume centers with appropriate perioperative management. Further studies with larger cohorts and longer follow-up are needed to refine protocols and determine long-term outcomes for these high-risk patients. Disclosure No

Abstract Introduction The opioid epidemic has encouraged increased efforts to minimize postoperative opioid use, particularly in urologic procedures. While short-acting local anesthetics are often used in inflatable penile prosthesis (IPP) placement, their effects diminish quickly, potentially leading to higher opioid requirements. Liposomal bupivacaine (LB), a long-acting local anesthetic, may reduce opioid requirements, but its cost and limited prospective data in IPP patients warrant further investigation. Objective To compare the efficacy of long-acting liposomal bupivacaine with short-acting ropivacaine in reducing postoperative pain and opioid consumption following inflatable penile prosthesis (IPP) placement. Methods This randomized controlled trial enrolled adult males undergoing primary IPP placement via a penoscrotal approach. Participants were randomized to receive either LB (20 mL Exparel + 20 mL bupivacaine 0.25%) or ropivacaine (40 mL of 0.5%) as part of a standardized multimodal analgesia protocol. All patients received acetaminophen, gabapentin, and meloxicam perioperatively, with oxycodone prescribed as needed postoperatively (figure 1). The primary outcome was postoperative opioid consumption measured in oral morphine equivalents (OME). Secondary outcomes included pain and anxiety scores assessed on postoperative days (POD) 3, 7, and 14 using visual analog scales. Results Only 13 patients completed the study due to difficulties in recruitment (9 in the long-acting group, 4 in the short-acting group). The long-acting group demonstrated consistently lower opioid consumption at all follow-up points. On POD 3, the median cumulative OME was 7.5 vs. 41.25 in the short-acting group. By POD 14, cumulative OME was 15.0 vs. 93.75. (Figure 2) Pain scores followed a similar pattern, with the long-acting group reporting lower median scores on POD 3 (4 vs. 6) and POD 7 (4 vs. 6). Anxiety scores were also lower in the long-acting group throughout the follow-up. Use of non-opioid analgesics was similar across both groups. Conclusions Despite a limited sample size, this trial showed consistent trends favoring LB over ropivacaine for reducing opioid use and pain following IPP placement. These findings suggest potential clinical benefit but require validation in larger, multicenter studies. The trial also illustrates the difficulty of conducting randomized studies when institutional practices strongly favor one approach. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Endo pharmaceuticals.

Abstract Introduction Clostridium Collagenase Histolyticum (CCH) is the only-FDA approved non-surgical, intralesional option for men with Peyronie’s disease. However, little is known regarding practice patterns of CCH providers due to lack of standardized protocols. Objective To evaluate practice patterns for providers approved to administer CCH to treat Peyronie’s disease (PD), this study was conducted. Methods The “Find a Xiaflex-Trained Urologist” search tool on the Endo International patient-facing website was utilized to identify clinicians offering CCH injections in the United States. A 24-question survey was mailed to these providers with topics including provider type, years in practice, therapies offered, and patient evaluation was distributed to providers on patient-facing Endo International Xiaflex Find a Provider web-based tool. Results 63 responses were obtained, including 41% fellowship-trained urologists (FTU), 40% non-fellowship-trained urologists (NFTU), 14% advanced practice providers, and 5% un-specified. Prior to therapy, over 63% of providers performed in-office assessment of an erect penis while only 35% obtained ultrasound. 32% always and 36% never performed an artificial erection prior to administering CCH. Plaques were most identified by palpation or patient-provided direction with penile modeling and traction the most common adjuncts. When comparing NFTU to FTU, there was no difference in volume of PD patients with 60% examining fewer than 10 per month. FTU were more likely to offer traction (p = 0.002), plaque incision/excision and grafting (p = 0.005), increase time between injections (p = 0.012), and less likely to encourage penetrative intercourse between cycles (p = 0.016). The incidence of post-operative hematomas or suspected corporal rupture was not significantly different, although FTUs were more likely to conservatively manage rupture. Conclusions Variability exists in provider practice patterns surrounding CCH injections with most evaluating less than 10 patients with PD per month. This calls to attention the need for evaluation of techniques, patient outcomes, and standardization of care. Disclosure Yes, this is sponsored by industry/sponsor: Endo Pharmaceuticals. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: Endo Pharmaceuticals.

Abstract Introduction Penile plication is an excellent approach for patients with congenital penile curvature and Peyronie’s disease. Beginning in March of 2023, patients who were candidates for penile plication were offered the procedure in the operating room under general anesthesia or in the office setting with no sedation. Fourteen patients opted for the procedure in the clinic. Objective We therefore sought to assess patient responses and experience after undergoing surgery in the clinic setting. Methods Fifteen patients, ages ranging from 21 to 74 were seen in clinic for penile plication surgery. Exclusion criteria included patients younger than 18 years and preoperative systolic blood pressure greater than 160. One patient was noted to have a systolic blood pressure over 200 and thus was unable to have the procedure. Five patients had a penile plication for congenital curvature, eight patients for Peyronie’s disease, and 1 patient had a release of a previously placed palpable plication suture. Degree of curvature, direction of curvature, presence of secondary curvature, presence of hinge defect, and indentation were not considerations in patient selection. Three patients were on anticoagulation, which was held prior to surgery. Twelve patients underwent a ventral approach and two a degloving approach. Results Patients are allowed and encouraged to eat and drink prior to the procedure. All patients were given a preoperative antibiotic, normally either Bactrim or ciprofloxacin prior to the procedure and 20 mg of oral versed. They were then taken to the in-office procedure room after consent was obtained. The procedure room contains a television for patients to watch. At the end of the procedure, an Exparel block was performed. Patients are then prepped and draped in standard sterile fashion. A dorsal penile nerve block and circumferential block were utilized at the beginning of the case. A catheter is not placed to help reduce patient discomfort. Alprostadil is injected to help identify curvature. Ten patients were noted to have dorsal, 2 patients’ ventral, and 2 patients’ lateral curvature with degree of curvature ranging from 30 to 60 degrees. Eight patients had a secondary curvature identified. Total number of plication sutures utilized ranged from 2 to 8. All procedures were successfully conducted, and patients discharged home. Patients were then contacted to determine their experiences with the procedure. Only seven patients were able to be reached. One patient did have a vasovagal response in the procedure room, but this resolved with a small snack. Average intraoperative discomfort was rated as a 2/10 and was mainly present during the initial block. All patients stated that they would choose this surgical approach again and have noted clinically significant improvement to their curvature. Conclusions Penile plication in the clinic setting reduces anesthetic risks as well as costs associated with the operating room. This study shows the safety and feasibility of this approach. Disclosure No.

Abstract Introduction We report outcomes for patients in which the IPP became unusable by the patient because of pump difficulties or inadequate fluid volume in the IPP system. Objective We sought to assess outcomes of penile implant single component exchange or fluid instillation in a cohort of patients, challenging the entire device replacement dogma. Methods 17 patients underwent single component exchange by a single surgeon. CT scan was obtained to ensure device integrity, assess for air in the system, and to delineate device details. In cases of pump difficulties, the old pump was removed and replaced with a “classic” Genesis Coloplast pump regardless of initial device brand (“Frankenstein” if brands are mixed). Patients are taught pump rocking techniques and have > 6 months of difficulty before exchange. Patients are warned of auto-inflation as there is no lock out valve in the Genesis pump. For fluid addition to the system, the two old connector collars are separated and sometimes re-used after saline is added to only the cylinders. We never add fluid to the reservoir using a piston syringe for fear of reservoir capsule rupture into adjacent structures. Revisions were copiously irrigated, as of 2022, with Irrisept. Results Pump exchange: 14 patients underwent single component pump exchange secondary to inability for the patient to be able to adequately cycle the device (11 AMS MS, 1 Coloplast Touch). Remarkable differences were noted in pump cycling between office exam (difficult), exam under anesthesia prior to incision (sometimes difficult), and once the pump is removed from its capsule (universally easy). Complications of these 14 patients include 1 fungal infection requiring replacement with a malleable device and one repeat pump exchange (AMS MS - AMS MS - Genesis). Two patients noted non-bothersome minor auto-inflation. The single Coloplast case had a remarkably thickened capsule after a likely low grade infection. All patients can successfully use their devices now. Fluid Addition: Three patients underwent fluid addition to the system. One had a significant proximal aneurysm for which we added 35 ml. A different case had both a pump exchange and 30 ml added to the system as the initial reservoir appeared to have folded cordoning off fluid. The final fluid addition occurred 18 months after initial Coloplast 22+2 cm placement in which the patient very aggressively cycled the device and could not obtain 10/10 erection. 30 ml was added to the system totaling 140 cc. All patients have done well with fluid addition with mean time since surgery of 1 year. Conclusions Pump exchange with genesis pump or simple fluid addition to the system are safe and feasible and successfully restores IPP functionality. The Frankenstein strategy is a viable alternative, although patients must be counseled that auto-inflation may occur. With modern day irrigation techniques and CT confirmation of fluid system integrity, the dogma to replace the entire device may actually carry higher morbidity in some patients. Disclosure No

Abstract Introduction Penile prosthesis placement in men on active anti-coagulation (AC) is controversial. The bleeding risk of continued blood thinners must be weighed against the increased thrombotic risk for patients when stopping them. Previously utilized techniques to decrease complication rates from AC include the use of a malleable implant only, leaving the IPP partially inflated for hemostasis, and placement of a drain. Objective We sought to assess outcomes of penile implant placement in men on clopidogrel, warfarin, apixaban, enoxaparin, and rivaroxaban in a multi-institutional study. Methods Data from 3 high volume implant centers were retrospectively obtained. Demographic characteristics, comorbidities, case information including secondary procedures, placement of drain, drain output, and complications were recorded. Data on patients with aspirin any dose alone were not included as all 3 centers do not routinely discontinue ASA at time of penile implant. One center never placed drains and used a penoscrotal approach, one center left a drain at least one day and removed when output was < 50 ml/8 hours and used a penoscrotal approach, and the last center placed a drain for 3 days and utilized an infra-pubic approach. Results 202 patients were continued on AC throughout surgery. 112 patients were on clopidogrel, 35 warfarin, 38 apixaban, 1 enoxaparin, 15 rivaroxaban, and 1 on combination therapy with clopidogrel and enoxaparin. AC requirement included peripheral vascular disease (55%), CHF (11%), cardiac stents (11.6%), DVT/PE/history of thrombosis (7%), atrial fibrillation (11%), cardiac valves (2.2%), stroke (1.3%), and preventive (0.9%). Nine patients on AC (3.98%) experienced complications including 4 significant events (1.9%): 1 major retropubic bleed requiring transfusion, 3 IPP infections and 5 minor events: 3 minor hematomas, 1 minor wound dehiscence and 1 CT negative stroke event. Drain outputs for the 3 day center averaged 113 ml, 81 ml and 30 ml of output per day respectively with a total average output average of 223 ml and experienced no hematomas nor infections. Drain output for the center with removal when < 50 ml/8 hours averaged 121 ml with the majority or patients having the drain for only one day. Drain output was significantly higher than historical non AC controls (121 vs. 72 ml p=.001) but there was no difference in hematoma rate. Three hematomas and 1 infection occurred in this group. AC type, revision surgery, scrotoplasty, or reservoir technique did not affect outcomes nor drainage (P>.05). Complication rate (IPP infection and hematoma rate) where not different when compared to large cohorts from respective institutions. Conclusions Our data shows a 1.9% rate of major complications in patients undergoing IPP placement on anticoagulation in high volume implant centers. Although this approach appears feasible and similar in complication rates in men not on AC, careful consideration of the risk benefit ratio should be undertaken. Our data indicate closed suction draining for 3 days may be warranted. Additionally, the retropubic bleed case argues for only submuscular reservoirs placed under direct vision which minimizes occult bleeding risk. In the majority of cases, elective IPP surgery should be delayed until it is safe to discontinue anticoagulation therapy. Disclosure No