Renterghem, Koenraad van

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 Climacturia has been reported in up to 64% of patients following radical prostatectomy (RP). In 2017, a prospective multicenter, multinational, investigational pilot study was conducted examining outcomes using a novel surgical technique, the Mini-Jupette sling, for the management of men with post-RP erectile dysfunction (ED) and climacturia and/or minimal stress urinary incontinence (SUI). We sought to report the 5-year outcomes from this original cohort. Objective To assess long-term safety and efficacy of the mini-jupette sling in the treatment of ED and concomitant mild SUI and/or climacturia Methods We identified patients who were enrolled in the previous multicenter study with post-RP ED and climacturia and/or mild SUI (2 ppd) and underwent IPP insertion with simultaneous placement of a Mini-Jupette sling. Data including current ppd, improvement in climacturia, complications, need for revision of IPP or additional urinary incontinence surgery, and date of most recent follow-up were collected. Results Of the original 38 patients, 5 have since died and 10 were lost to follow-up with 23/38 (61%) patients available for evaluation of long-term outcomes. The average follow-up time was 59 months (SD= 8.8) with a mean age of 69 years (SD= 6.8). Most patients (n=21, 91%) had subjective improvement of SUI and climacturia. One patient with persistent bothersome incontinence underwent artificial urinary sphincter (AUS) placement in 2018 with no complications, while the other is still considering a repeat procedure due to minor but persistent SUI. The mean ppd decreased from 1.4 preoperatively to 0.3 at a mean 5 years of follow-up. Most patients reported satisfaction in their urinary symptoms with 91% and 73% reporting improvement in SUI and climacturia respectively, compared to 86% and 93% respectively in the original series. One (4.3%) patient had an IPP revision for pump malfunction. There were no device infections reported. Conclusions The Mini-Jupette sling appears to be a safe and effective procedure with durable improvements in SUI and climacturia at 5 years of follow-up. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Clarus Therapeutics, Antares Pharma, Acerus, Intuitive Surgical, Fidalis, Hims & Hers Health Inc

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.

Abstract Background After radical prostatectomy (RP), erectile dysfunction, often necessitating the need for inflatable penile prosthesis (IPP) insertion, and urinary incontinence and climacturia can ensue. Aim To assess the efficacy and safety of the mini-jupette, a mesh used to approximate the medial aspects of the 2 corporotomies at the time of IPP insertion, for the management of climacturia and urine leakage in patients with minimal incontinence. Methods We conducted a pilot multicenter study of patients with post-RP erectile dysfunction and climacturia and/or mild urinary incontinence (≤2 pads/day [ppd]) undergoing IPP insertion with concomitant placement of a mini-jupette graft. Outcomes Pre- and postoperative erectile function, continence and climacturia, and overall surgical outcomes were assessed. Results 38 patients underwent the mini-jupette procedure. The mean age of the population was 65.3 years (SD = 7.7). 30 had post-RP climacturia and 32 patients had post-RP incontinence (mean = 1.3 ppd, SD = 0.8). 31 patients received Coloplast Titan, 4 received AMS 700 LGX, and 3 received AMS 700 CX IPPs. Mean corporotomy size was 2.9 cm (SD = 1.0). Mean graft measurements were 3.2 cm (SD = 0.9) for width, 3.3 cm (SD = 1.3) for length, and 11.0 cm2 (SD = 5.1) for surface area. At a mean follow-up of 5.1 months (SD = 6.9), there were 5 postoperative complications (13.2%) of which 4 required explantation. Climacturia and incontinence were subjectively improved in 92.8% and 85.7%, respectively. Mean ppd decreased by 1.3 postoperatively. Clinical Implications The Andrianne mini-jupette is a feasible adjunct to IPP placement that can be used for subsets of patients with post-RP climacturia and/or minimal incontinence. Strengths and Limitations Strengths of this study include the novel nature of this intervention, the multi-institutional nature of the study, and the promising results demonstrated. Limitations include the retrospective nature of the study and the heterogeneity of the techniques and grafts used by different surgeons involved. Conclusion Longer follow-up and larger patient cohorts are needed to confirm the long-term safety and benefits of this intervention.