Citations

Abstract Background 0.05% Chlorhexidine gluconate (CHG) is now commonly used as an antiseptic irrigation for inflatable penile prosthesis (IPP) surgery. Limited in vitro data suggest compatibility of 0.05% CHG with antibiotic impregnated IPP devices; however, very little clinical research exists to guide use of 0.05% CHG in this population. Aim Assess the relationship of 0.05% CHG and antibiotic impregnated IPP infection in a large multi-institutional cohort. Methods We retrospectively reviewed a multi-institutional cohort of patients who underwent antibiotic impregnated IPP implantation. We identified cases using intraoperative 0.05% CHG and an equal number of consecutive control cases without 0.05% CHG use from each center for comparison. The primary outcome was IPP infection requiring explantation. Patient demographics and surgical variables were analyzed using chi-square tests and multivariable logistic regression to identify variables associated with infection. Outcomes The primary outcome was IPP infection requiring device explanation. Results Among 14 participating institutions, 761 cases using an antibiotic impregnated IPP were analyzed. Of these, 348 (45.7%) had 0.05% CHG used during the case. Median follow-up was 4 months (interquartile range 1-12) for the 0.05% CHG group and 8 months (interquartile range 2-21) for the control group. Intraoperative 0.05% CHG utilization was not associated with antibiotic impregnated IPP infection rate (1.9% vs. 2.0%, P = .9). On multivariable analysis, prior IPP infection (OR 6.32, 95% CI 1.32-30.2, P = .021) and prior priapism (OR 10.01, 95% CI 1.18-89.7, P = .039) were associated with increased infection risk. Clinical implications The use of 0.05% CHG irrigation with antibiotic impregnated IPPs was associated with similar infection rates compared to antibiotic irrigation. Strengths and limitations Limitations include the use of a historical comparator cohort which may introduce unknown confounders, practice variation between multiple sites, shorter follow-up in the 0.05% CHG cohort, and the low incidence of IPP infection which may limit statistical power despite a large sample. The major strengths include the large, multi-institutional cohort, and the use of consecutive patients to minimize selection bias. Conclusion 0.05% CHG utilization was not associated with infection rates in antibiotic impregnated IPPs.

Abstract Introduction Peyronie’s Disease (PD) is a fibrotic disorder of the tunica albuginea leading to penile curvature, pain, and sexual dysfunction. Intralesional therapies are a non-surgical treatment strategy aiming to modulate fibrosis and reduce deformity. Intralesional verapamil, a calcium channel blocker, has been used to inhibit fibroblast proliferation and collagen synthesis, but its clinical effectiveness remains controversial. Despite widespread use, existing literature is heterogeneous in design and outcome measures. Objective We aimed to systematically review and summarize the evidence from prospective clinical trials assessing the efficacy and safety of intralesional verapamil. Methods Data extraction was carried out independently by the presenting author and a board-certified librarian. We conducted a structured literature search using PubMed, Scopus, and Web of Science for prospective trials from 2015-2025 evaluating intralesional verapamil use in patients with PD. Inclusion criteria were: [1] prospective study design, [2] adult patients with a clinical diagnosis of PD, [3] use of intralesional verapamil as monotherapy or in combination, and [4] reported outcomes on penile curvature, and sexual function. Data extraction included study design, sample size, outcome measures, and follow-up. Risk of bias and quality assessment was performed using the Cochrane Risk of Bias 2.0 scale. Results A total of 199 studies were screened. A total of 6 prospective trials were selected after excluding trials who were not compliant with our criteria, reporting on 754 patients with 1 to 24 months follow-up. RCTs evaluated were of moderate quality with a low risk of bias, but 3/6 had a high risk of bias. Across randomized trials, verapamil monotherapy resulted in modest improvements in curvature (range mean change in penile curvature -2° to -16°). In contrast, combination therapies or alternative injectables such as collagenase (CCH) and tiocolchicine showed greater curvature improvements (–28° in Chung; ~10° in Toscano). In non-randomized studies comparative studies, verapamil (Ver) demonstrated consistent improvement in penile curvature (~4.5° reduction [Cocci 22]), with sustained results at 24 months. Nevertheless, in these studies HA was superior to Verapamil (~9.5° reduction). Erectile function, measured by IIEF-5, improved modestly across studies, with the greatest gains observed in combination therapy arms or HA groups. Conclusions Intralesional verapamil offers modest improvements in penile curvature and erectile function in Peyronie’s Disease but appears less effective than alternative agents such as hyaluronic acid, collagenase, or combination therapies. Heterogeneity in trial design and moderate risk of bias limit definitive conclusions. Further high-quality, blinded randomized trials are needed to establish optimal intralesional treatment strategies. Disclosure No

Abstract Introduction 0.05% Chlorhexidine Gluconate (CHG) has gained popularity as an irrigant for inflatable penile prosthesis (IPP). In vitro data has explored interactions between CHG and minocycline/rifampin impregnated (M/R) IPP surfaces Objective We aimed to assess clinical infection rates between intraoperative CHG use and M/R impregnated IPPs in a large multi-institutional cohort. Methods We conducted a retrospective analysis of 1,604 patients who underwent IPP implantation across 12 referral centers. Data collection spanned from January 1, 2017 to March 1, 2024. Each surgeon contributed patients who underwent IPP implantation with the use of CHG as an irrigant and an equal number of consecutive control patients where CHG was not used. The primary outcome was explant for postoperative infection. Patient demographics were compared using chi squared testing and logistic regression analysis was performed to assess factors associated with infection. Results M/R impregnated devices accounted for 695 cases. The incidence of infection with intraoperative CHG use was 1.7% (5/289) and was not significantly different from the 2.5% (10/406) infection rate in those without CHG (p=0.429). Patients with infection had a higher prevalence of hypertension and history of priapism (Table 1). On logistic regression analysis, only a history of priapism was significantly associated with an increased odds of infection (OR 11.47, 95%CI 2.25-58.40, p=0.003). Intraoperative CHG use was not associated with postoperative infection (OR 0.69, 95%CI 0.2-2.06. p=0.514). Conclusions In a large multi-institutional cohort, there was no difference in infection rate for patients with or without intraoperative CHG use, consistent with prior in vitro findings. 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 Introduction The optimal antimicrobial prophylaxis strategy for inflatable penile prosthesis (IPP) surgery remains a subject of ongoing investigation. Our institution recently discontinued the use of chlorhexidine gluconate (CHG) and returned to traditional antibiotic-based prophylaxis protocols. Objective To evaluate infection rates following the reinstitution of antibiotic-based prophylaxis after discontinuing CHG in IPP surgery. Methods We conducted a retrospective, consecutive cohort study of patients who underwent Coloplast Titan IPP insertion between May 2024 and May 2025. The antibiotic prophylaxis protocol consisted of rifampin/gentamicin device dipping and vancomycin/gentamicin irrigation. Primary and revision cases were analyzed separately. Results A total of 188 patients underwent IPP insertion during the study period, including 119 primary implantations and 69 revision procedures. Mean patient age was 69.6 ± 11.5 years, BMI was 27.6 ± 4.2 kg/m2, and operative time was 67.1 ± 24.1 minutes. No infections occurred in the primary implantation cohort. One infection (1.4%) occurred in the revision group in a diabetic patient with prolonged operative time (176 minutes). Compared to our previously published data using CHG, infection rates decreased significantly in the revision group (1.4% vs. 9.67%, p < 0.001), while the primary group showed a numerical reduction from 2.22% to 0%. Conclusions The reinstitution of antibiotic following discontinuation of CHG resulted in significantly lower infection rates, particularly in revision cases. These findings support the continued use of antibiotic dipping and irrigation protocols for IPP surgery as a safe and effective strategy for infection prevention. Disclosure No

Abstract Introduction Device malfunction remains a serious concern for patients with inflatable penile prosthesis (IPP), with pump failure being one of leading causes of revision surgery. Complete device replacement has been the traditional approach, but partial device replacement for the pump may offer a less invasive and cost-effective alternative, with potentially lower complication risk. Objective To evaluate the safety, efficacy, and clinical outcomes of pump replacement (with or without obvious tubing leak/fracture), manipulation or fluid addition in patients undergoing IPP revision surgery. Methods A retrospective review was conducted on patients who underwent IPP pump replacement with or without additional component exchange by a single surgeon, between January 2018 and April 2025. Thirty patients met the inclusion criteria. Clinical, intraoperative and postoperative data were collected and descriptively analyzed. Outcomes included postoperative infectious and non-infectious complication rates. Results The median age at revision was 77 years, with a median time to revision of 76 months post-implantation. Most common indications were frozen or pump difficulties (67%), pump + tubing damage (30%) and fluid addition requirement (10%). No intraoperative complications occurred. Postoperative complications were reported in 3 patients (10.0%), all due to mechanical malfunction, with no infections observed. Median time to complication was 24 months (IQR 7–72). One patient progressed to IPP explanation after successive revisions for impending erosion not thought related to pump manipulation. Another underwent complete replacement at 7 months for fluid leak from reservoir. A third required non-exchange revision at 24 months. The majority (91%) received Coloplast pumps. The median operative time was 53 minutes (IQR 43–70). Conclusions Pump replacement appears to be a safe and effective option for select patients, potentially reducing surgical morbidity and preserving viable components. The absence of infection in this series is reassuring, particularly in a revision setting where infection risk is amplified. Consideration of device age and patient specific factors is important in guiding the choice between partial and complete component exchange. 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 is often difficult to distinguish, yet it remains paramount given the glans ischemia principle: “when in doubt, take it out.” Objective We present several clinical scenarios and associated postoperative images wherein there was concern for post-IPP glans ischemia based on initial clinical examination. In addition, we review pertinent clinical factors that can be used to help distinguish between greater than “average” glans ecchymosis and true ischemia. Methods We present four cases from 2025 and describe clinical factors likely responsible for increased glans discoloration. Results Traditional risk factors for glans ischemia are constrictive IPP wrap, vasculopathy, use of prolonged large bore catheters, and concomitant surgery (circumcision, distal counter-incision, urethral/neurovascular bundle mobilization). Case 1 was a patient with a history of radiation for prostate malignancy who had notably hypervascular corpora intraoperatively. On postoperative day (POD) #1, the urethral meatus was ecchymotic along with patchy ecchymosis throughout the glans. The Kerlix wrap can be seen around the penile shaft up to the corona. Removing the constrictive wrap and increasing room lighting revealed a well-vascularized glans with spotty ecchymosis likely from passage of the Keith needles during deployment. Case 2 was another patient examined on POD1 after uneventful IPP placement under local anesthesia. Note the similar level of ecchymosis involving the scrotum. Case 3 is another patient examined POD1 from a penoscrotal IPP that required multiple firing attempts with the Keith needle. Again, multifocal areas of patchy ecchymosis are interspersed with areas of normal appearing glans. The patient’s skin color was also similar in appearance to the areas of ecchymosis, requiring careful attention to detail to differentiate. Finally, Case 4 is an image on POD0 after uneventful IPP. The patient required several Keith needle passes because Furlow tool severed suture. Notably, decision was made to leave the penile implant in place in all cases. The penile wrap and/or catheter was removed and lighting was optimized to evaluate for clinical change. No patient reported paresthesia or pain out of proportion to the clinical examination. All glans were warm to the touch. Rates of glans bruising at POD3 for 298 implants performed since 2024 under local anesthesia, with bruising scored 0-4, were as follows: 0: 3.7% 1: 48.7%, 2: 25.5% 3: 21.1% 4: 0.3%. This demonstrates high rates of glans bruising with local anesthesia. We speculate that the increased rate of glans bruising may be attributed to the aggressive nature of the local anesthesia block, which can result in vasodilation and ecchymosis due to needle trauma and increased vascular permeability. Conclusions IPP cylinder deployment requiring multiple Keith needle punctures, constrictive post-op penile wrap, hypervascular corpora, exam/images with poor lighting, extensive bruising in other areas, and IPPs performed under local anesthesia appear may contribute to glans discoloration that mimics ischemia. A detailed physical exam and close clinical monitoring are essential when postoperative glans discoloration is observed. Disclosure No

Abstract Introduction Inflatable Penile Prostheses (IPPs) are a surgical implant used to treat erectile dysfunction in patients who do not respond to clinical treatments. IPP cylinder size often changes with cylinder exchange upon revision, but trends in these changes have not been formally assessed in the existing literature. Objective To analyze patient data for changes in implant size upon first revision. Methods Data included patients who underwent IPP surgical revision at Mayo Clinic Rochester between January 2021 and May 2024. Inclusion criteria specified cylinder exchange upon first revision of the IPP. A total of 48 patients were included in the analysis. A Bayesian regression was used to estimate the posterior probability of an increase in cylinder size upon first revision, after adjusting for patient age, revision service provider, and duration between implant and revision as covariates. Linear regression was used to assess the relationship between the extent of cylinder size increase and duration before revision. Results The median increase in cylinder size is 2 cm for the left cylinder and 1.75 cm for the right cylinder. The median increase for each patient’s average cylinder size is 1.625 cm. The median percentage increase in cylinder size is 9.76% for the left cylinder and 8.11% for the right cylinder. The median percentage increase for each patient’s average cylinder size is 8.13%. Posterior probabilities of increase were significant for the left cylinder, right cylinder, and the average cylinder size (Left PP: 97.53%; Right PP: 98.05%; Average PP: 98.05%). The extent of cylinder size increase is not significantly associated with duration before revision (Left p-value = 0.476; Right p-value = 0.500). Conclusions Patients and surgeons can expect about a 10% increase in cylinder size with their first revision. However, the extent of increase is not significantly associated with the duration between implant date and first revision. Future research efforts should focus on identifying where exactly this additional size is generated and what extent of size increase amounts to a noticeable difference for patients. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast

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