Alwaal, Amjad

Abstract Introduction Predictors of intraoperative corporal perforation and delayed cylinder complications in inflatable penile prosthesis (IPP) placement have not been well-delineated in the literature. Inflatable penile prosthesis (IPP) can offer high satisfaction rates of patients, but this procedure is not without complications that can be encountered intraoperatively and postoperatively. Particularly, predictors of intraoperative corporal perforation and delayed cylinder complications in IPP placement have not been well-delineated in the literature. Objective We evaluated our retrospective multi-institutional database of IPP surgeries performed by expert implant surgeons to identify risk factors that are predictive of the development of these non-infectious complications. Methods IPP cases performed by sixteen international implanters from 2016-2021 were identified. All primary and revision cases were included. Salvage cases for infection were excluded. Demographic characteristics, intraoperative variables, and postoperative outcomes were assessed. Poor corporal integrity (PCI) was defined as intraoperative corporal complications (proximal and/or distal perforation of the corpora, corporal crossover) or postoperative corporal complications (cylinder erosion, extrusion, impending erosion, or deformity). Risk factor analysis and multivariate analysis were performed to identify predictors of PCI. Results A total of 5406 IPP cases across 16 separate institutions were assessed. There were 163 (3.0%, mean age 64) cases of PCI. Of the 156 complications that occurred, 101 (64.7%) occurred intraoperatively, while 55 (35.3%) occurred postoperatively. The rates of diabetes (p=0.669), vascular disease (p=0.054), and history of intracavernosal injections (p=0.111) all had no statistically significant effect on corporal integrity. Patients with PCI tended to have hypertension (p=0.045), current smoking (p=0.03), history of IPP infection (p<0.001), and history of shunt for priapism (p<0.001). On multivariate analysis, predictors of PCI include hypertension (OR 1.64 (1.09-2.47), p=0.018), history of IPP infection (OR 4.41 (2.52-7.84), p<0.001), and age (OR 1.02 (1.00-1.04), p=0.027). Obesity was found to be protective (OR 0.63 (0.42-0.95), p=0.027). Conclusions Our multicenter analysis found that hypertension, current smoking, history of IPP infection and age were risk factors for complications associated with poor corporal integrity. Recognizing these risk factors preoperatively can allow for improved patient-specific counseling and changes in surgical strategy to potentially prevent these complications. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast and Boston Scientific.

Abstract Introduction In primary implant patients without significant corporal fibrosis, penile implant surgical technique varies in implementation of either single dilation (SingD) or sequential dilation (SeqD). Vigorous debate exists regarding both methods, but there is no robust evidence supporting one technique over the other in the literature. Objective We compared the rates of intraoperative complications and postoperative outcomes from a large international database of inflatable penile prostheses (IPP) performed by expert implant surgeons to determine if there were any significant differences in rates between SingD and SeqD. Methods We analyzed IPP cases performed by international implanters from 2016-2021. All primary implant cases were included, while revision cases, salvage operations, and patients with evidence of corporal fibrosis were excluded. Intraoperative complications and postoperative noninfectious outcomes were assessed between the two groups. These included proximal/distal perforation and cylinder crossover. Results After exclusion based on aforementioned criteria, we identified 3045 patients who underwent IPP. After 1:1 propensity matching of both groups, we analyzed 572 patients who underwent SingD and 572 patients who underwent SeqD. Between the two groups, more men of non-Caucasian race underwent SingD vs SeqD (p<0.001). There was a significant difference in cylinder length in the SeqD group vs the SingD group (20cm ± 1.5 vs. 20 cm ±2 respectively, p=0.018). There were 8 (0.7%) intraoperative complications in total, 7 in the SeqD group and 1 in the SingD group (p=0.034). Of these intraoperative complications, 3 (37.5%) patients who underwent SeqD sustained a proximal perforation, 3 (37.5%) sustained distal crossover, and 1 (12.5%) sustained proximal crossover. 1 patient (12.5%) with intraoperative complication who underwent SingD sustained a proximal perforation. Postoperatively, 78 (82%) of complications were in the SeqD group and 17 (18%) in the SingD group (p<0.001). Of these postoperative complications, there were 15 patients with bleeding or hematoma, of which 14 were in the SeqD group vs 1 in the SingD group (p<0.001). Of the 35 patients who were noted to have device-related malfunction, 29 underwent SeqD and 6 underwent SingD (p<0.001). Postoperative complications were more related to technical error in the SeqD vs the SingD group (11 patients and 1 patient respectively, p<0.011). On multivariate analysis, prior radical prostatectomy was predictive of intraoperative complications (OR 4.59 with IQR 1.39-15.16, p=0.024), while larger cylinder size seemed to be protective (OR 0.66 with IQR 0.50-0.89, p=0.006). On multivariate analysis, SeqD was predictive of postoperative complications (5.16 with IQR 3.01-8.83, p<0.001), as was history of priapism (4.15 with IQR 1.30-13.29, p=0.017). Patients who undergo SeqD may be calibrated by the surgeon to have more complex corpora, which could explain higher complication rates. We identified 3045 patients who underwent IPP. Conclusions In our international multicenter assessment of primary IPPs without corporal fibrosis performed by expert surgeons, patients undergoing single dilation appear to have slight benefit in total cylinder length. Sequential dilation may confer greater risk of intraoperative and postoperative complications, including bleeding and hematoma. Single dilation is a safe technique for primary inflatable penile prosthesis. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast and Boston Scientific

Abstract Introduction The American Urological Association (AUA) recommendations on antibiotic prophylaxis in penile implant surgery are based on low quality evidence and expert opinion. Recent evidence suggests the recommended regimens may be suboptimal. Objective To determine if the AUA recommended antibiotic regimen (vancomycin + gentamicin) for primary penile implant surgery is associated with a higher infection risk than non-standard regimens. Methods We performed a multicenter, retrospective cohort study of patients undergoing primary IPP surgery. Patients undergoing revision surgery or with a history of IPP placement were excluded. Additionally, patients who underwent concomitant procedures for Peyronie’s disease or stress urinary incontinence were excluded. Patients were divided into those receiving standard AUA antibiotic prophylaxis (vancomycin + gentamicin) and those receiving any other (non-standard) antibiotic prophylaxis. The time to postoperative device explanation due to infection via a Cox regression model, the microorganisms involved, and the management of patients with device infection were evaluated. A subgroup analysis to identify the appropriate dosage of gentamicin was also performed. Results 4,161 patients underwent primary IPP placement (2,411 received vancomycin + gentamicin and 1,750 received other regimens). The infection rate was similar between groups, 1.0 vs 1.2% for standard vs non-standard prophylaxis. In the multivariate Cox regression analysis, the use of vancomycin + gentamicin (HR: 2.74, 95%CI: 1.38-5.41, p=0.004) and diabetes (HR: 1.87, 95%CI: 1.03-3.39, p=0.04) were significantly associated with higher risk of device explantation due to infection. Concomitant infusion of antifungals (HR: 0.08, 95%CI: 0.03-0.19, p<0.001) was associated with lower risk of infection. Staphylococcus aureus and Escherichia coli were the most frequently cultured microorganisms. Device infection was most commonly managed with salvage using a malleable prosthesis (40.4%). In patients of both groups receiving gentamicin as part of perioperative antibiotic prophylaxis, the use of weight-based gentamicin compared to 80 mg gentamicin was associated with similar risk of device explantation due to infection (HR: 2.88, 95% CI: 0.83 to 10, p = 0.1). Conclusions Vancomycin + gentamicin for antibiotic prophylaxis in primary penile implant surgery is independently associated with a higher infection risk than non-standard antibiotic regimens while antifungal use is associated with lower infection risk. There does not appear to be a difference in weight-based vs low dose (80mg) gentamicin on infection risk. Our results further demonstrate the importance of antifungal use in prophylaxis regimens. Additionally, a critical review of the recommended prophylactic regimens is needed. Tailoring individual regimens to local antibiograms may provide the best infection prevention. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Boston Scientific, Antares Pharma, Clarus Therapeutics, Cynosure, Promescent, Sprout, Viome.