Ziegelmann, Matthew

Abstract Background Chlorhexidine gluconate (CHG) (0.05%) has recently been suggested as a dip and irrigation solution at time of inflatable penile prosthesis (IPP) surgery. Aim This study evaluated infection rates before and after implementing CHG protocol while investigating concurrent risk factors contributing to post operative infections. Methods A retrospective, consecutive cohort study was performed that included patients who underwent insertion of a Coloplast Titan IPP including both virgin and revision cases between 2021 and 2024. Cases performed from January 2021 to August 2022 utilized rifampin/gentamicin for dip and vancomycin/gentamicin for irrigation (ABX), whereas those from October 2022 to May 2024 utilized CHG for both dip and irrigation. Perioperative risk factors including dip and irrigation solution used at time of surgery were compared between groups. Outcomes We defined the incidence of postoperative infection and risk factors associated with infection in each group. Results The incidence of infection was significantly higher in the 0.05% CHG group (13/377) compared to the ABX group (0/320) (P < .001). When analyzed separately by subgroup, virgin cases treated with CHG for dip and irrigation demonstrated a significantly higher infection rate (7/315) compared to those in the ABX group (0/280) (P = .012). Similarly, in revision cases, the CHG group also exhibited a significantly higher infection rate (0/40) than the ABX group (6/62) (P = .043). Univariable analysis of the CHG cohort identified three significant risk factors for infection: diabetes mellitus (DM), extended operative time (OP), and revision surgery (P = .003, .001, and < .001, respectively). Multivariable regression analysis revealed that patients with DM had a 5.7-fold increased risk of infection (OR: 5.70, P = .004), while those undergoing revision surgery faced a 5.3-fold higher risk (OR: 5.26, P = .004). Additionally, each minute increase in OP was associated with a 1% higher infection risk (OR: 1.01 per minute, P = .007). These associations remained significant after adjusting for all variables in the model. Clinical Implications Prosthetic surgeons should be cautious about adopting 0.05% CHG for both dip and irrigation in the absence of strong clinical evidence demonstrating its non-inferiority to antibiotic solutions. Strengths and Limitations This is the first clinical study reporting infection rates after IPP surgery using 0.05% CHG for both dip and irrigation. While retrospective and non-randomized, we present a relatively large sample size of patients. Conclusions Our findings identify four risk factors for penile prosthesis infection: usage of the 0.05% CHG solution for dip and irrigation solution of Coloplast hydrophilic-coated devices, DM, revision surgery, and extended OP.

Purpose of review Peyronie's disease characterizes a condition in which there is angular curvature of the penis. We know that the most patients with Peyronie's disease will not have spontaneous resolution of their penile curvature. As such, patients who desire treatment can elect for either surgical or nonsurgical therapy. Herein, we discuss the contemporary nonsurgical management options for Peyronie's disease. Recent findings Nonsurgical management options for Peyronie's disease include oral therapy, intra-lesional injections, and penile traction therapy. At the time of this review, there is essentially no high-level evidence demonstrating any benefit for oral therapy. Penile traction therapy has evolved over the past decade with second-generation devices demonstrating strong efficacy and more convenient treatment regimens. Intra-lesional options include collagenase Clostridium histolyticum (CCH), verapamil, and interferon alpha-2b. The IMPRESS trial garnered the strongest level of evidence (two randomized, double-blind, placebo-controlled trials) to support the safety and efficacy of CCH. Verapamil is an option supported by several urological societies; however, the evidence supporting its efficacy is inconsistent between several notable series and randomized studies. IFN alpha 2b can produce modest improvement in curvature, however, is not available for use in North America. Summary Herein, we will discuss notable advances in nonsurgical management of Peyronie's disease.

Abstract Introduction Obesity, defined as an elevated Body Mass Index (BMI) >30, is a prevalent public health concern with far-reaching implications for various medical procedures and outcomes. In the context of inflatable penile prosthesis placement (IPP), where patient well-being and surgical success are of paramount importance, the impact of obesity on postoperative and intraoperative complications warrants thorough investigation. Objective We aimed to investigate the impact of BMI on both postoperative and intraoperative complications in an international, multi-institutional cohort of patients who underwent IPP placement. Methods We performed a retrospective chart review of 4,398 cases. These cases were divided into two distinct groups based on BMI: less than 30 (n = 2,260) and greater than or equal to 30 (n = 2,138). The study assessed various surgical factors as well as complications, including overall complications, corporal scarring, incontinence, intraoperative complications, proximal perforation, distal perforation, proximal crossover, distal crossover, and urethral injury. Results Our analysis revealed that there were no statistically significant differences in intraoperative or postoperative complications between the two BMI categories. Notably, proximal corporal measurement was significantly higher for >30 BMI group with 1858 (86.9%) compared to 1919 (84.9%) for <30 BMI group, (p = < 0.001). The incidence rates for overall complications (30.2% vs. 28.7%; p = 0.164), corporal scarring (18.2% vs. 16.7%; p = 0.36), incontinence (3.53% vs. 3.13%; p = 0.076), intraoperative complications (1.94% vs. 1.68%; p = 0.253), and specific complications all exhibited no significant differences. Similarly, post-operative complications, including both non-infectious (6.99% vs. 6.22%; p = 0.215) and infectious (2.61% vs. 1.87%; p = 0.165) complications, did not significantly vary between BMI categories. Conclusions Our findings indicate that BMI does not exert a statistically significant influence on postoperative and intraoperative complications in the context of high-volume prosthetic urology. In the absence of any other differences between patients of differing BMIs, the IPP industry may need to consider device specific alterations with pump tubing length in obese patients. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Clarus Therapeutics, Antares Pharma, Acerus.

Abstract Introduction Surgical treatment options for Peyronie’s disease (PD) include penile plication, plaque excision with grafting, and penile prosthesis placement with straightening maneuvers. Choice of surgical incision depends on location and severity of curve, concomitant procedures, and surgeon preference. Objective To assess risk of wound complications after PD surgery stratified by ventral versus subcoronal incision type. Methods A single surgeon retrospective chart review was conducted for all patients undergoing PD tunica albuginea plication (TA) or plaque excision with grafting (PEG) from Aug 2019 to June 2023. Wound complication was classified as any dehiscence or physical examination finding suspicious for infection within 30d of surgery. A Mann–Whitney U Test was used to compare demographic variables and wound complication rate based on ventral and subcoronal approaches. Results Of the 161 patients included, 105 underwent TAP and 56 underwent PEG. All patients who underwent PEG had at least one plication suture performed to correct mild residual curvature after grafting. A ventral midline penile incision was used in 81 patients (50%) and subcoronal in 80 patients (50%). Wound complications within 30d of surgery were found in 10 patients (6%), including 8 (10%) with ventral incisions versus only 2 (3%) subcoronal (OR 4.27; 95% CI 0.87-20.79; p = 0.09). There was no significant difference in wound complications between TAP and PEG cohorts. Wound complications included dehiscence requiring repeat closure (n = 1) and superficial wound infection necessitating antibiotic therapy (n = 9). In a subgroup analysis of patients who underwent TAP only, 8 patients (7.6%) with a ventral approach experienced a 30d wound complication compared with 1 patient (3.4%) with a subcoronal approach. Conclusions Penile straightening surgeries are associated with a low rate of significant wound infections. While not statistically significant, a ventral incision may have a slightly higher risk than subcoronal for wound complications within the first 30d of surgery. Both ventral and subcoronal incisions can offer excellent exposure and may be considered for patients requiring plication and/or grafting approaches. Disclosure No.

Abstract Introduction Discrimination and sexual harassment within the workplace have a negative impact on well-being and productivity and are often underreported due to lack of comfortability in confronting the offender. Objective We aim to assess the prevalence of these abusive behaviors within a urology department and the impact of a dedicated training session on comfortability reporting/confronting discrimination and harassment. Methods Employees within a urology department at a single institution were invited to take a survey regarding discrimination and harassment both before and after a dedicated training session on reporting and confronting these behaviors. Statistical analyses were performed between pre- and post-survey groups, genders, and roles within the department. Results A total of 77 participants were included, 52 (67.5%) identified as female. Roles within the department included physician (25; 32.5%), advanced practice provider (11; 14.3%), nurse (20; 26%), and nonclinical staff (21, 27.2%). More women reported experiencing sexual harassment at least once a year compared to men (38.6% vs. 16.7%, p < 0.001). Patients were the most commonly reported offenders of abusive behaviors towards staff (p < 0.05) Fig. 1.A. The training demonstrated a positive impact in respondent comfort level with addressing gender discrimination (14.3% increase in comfort; p = 0.043) Fig. 1.B. Conclusions Specific training on strategies for addressing abusive behaviors can help employees feel empowered to confront gender discrimination by both patients and their peers. Disclosure No.

Abstract Introduction Inflatable penile prosthesis (IPP) surgery is a well-established treatment for erectile dysfunction (ED). There is little information in the literature regarding the utilization of perioperative antimicrobial prophylaxis in primary and revision IPP surgeries. Objective We investigated the patterns of perioperative antimicrobial prophylaxis among a large multinational cohort of primary and revision IPP surgeries. Methods We conducted a retrospective analysis of 5,400 patients (4,187 primary IPP patients and 849 revision IPP patients) from our Prosthetic Urology Multi-Institutional Partnership (PUMP) institutions. Usage data for intravenous (IV), preoperative oral, and postoperative oral antimicrobials were analyzed. We specifically assessed patient profiles, antimicrobial selection, and antimicrobial duration. Multivariate statistical analyses were conducted to identify significant variations between primary and revision surgeries. Results For patients undergoing primary IPP placement, 81.9% received IV antibiotics for <24 hours whereas 18.1% received IV antibiotics for >24 hours. Preoperative oral antimicrobials were used in 59.4% of patients and 99.4% received postoperative oral antimicrobials. The overall infection rate for primary implants was 2%. Notably, quinolone administration shows a higher postoperative infection rate (11.4%) compared to gentamicin (1.9%), cephalosporin (0%), and vancomycin (1.0%). Multivariable regression analysis identifies factors such as a history of infection, diabetes, and priapism as predictors for postoperative infections. Furthermore, the study finds that perioperative antifungal use is associated with a decreased risk of infection. Conclusions This study provides valuable insights into the patterns of perioperative antimicrobial prophylaxis. Duration, type, and route of antibiotics given preoperatively or postoperatively do not affect postoperative infection rates among high volume prosthetic urologists. Giving IV antibiotics for more than 24 hours does not affect postoperative infection. Perioperative antifungals are a protective factor. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Clarus Therapeutics, Antares Pharma, Acerus.

Abstract Introduction Peyronie’s disease (PD) is a connective tissue disorder characterized by the replacement of normal elastic fibers of the tunica albuginea with collagen-containing plaques. This alteration may result in penile deformities that are most evident during erection, which can lead to significant emotional distress, sexual dysfunction, and penile pain. Collagenase clostridium histolyticum (CCH) is indicated for the treatment of adult men with PD with a palpable plaque and curvature deformity of at least 30 degrees at therapy onset. Notably, men with ventral curvature (VC) were not included in the CCH clinical trial program due to potential concerns over the proximity of the urethra to the site of injection. Currently, CCH is contraindicated in Peyronie’s plaques that involve the penile urethra. Urethral involvement of a PD plaque is rare due to the anatomy of those structures. PD plaques form in the tunica albuginea as opposed to the corpus spongiosum which directly surrounds the urethra. Also, multiple prospective and retrospective studies have documented favorable outcomes using CCH for PD with VC. Thus, CCH may be a reasonable treatment option for patients suffering with ventral and ventrolateral penile curvatures in the absence of direct urethral involvement. Objective We are conducting a multicenter real-world retrospective collaborative research study of the safety and effectiveness of CCH in the treatment of men who had PD with VC. Methods A Phase 4, multicenter, noninterventional, retrospective review of medical records from approximately 10-15 US physician sites is being conducted. Eligible patients include those ≥18 years old with a PD diagnosis with VC and a palpable plaque that had been treated with CCH from 2014 to the study start date at the site. The primary effectiveness endpoint is percent change from (pretreatment) baseline in degree of VC at the last visit as measured at follow-up within 6 months post-treatment. Secondary endpoints include mean change from Baseline in VC and the proportion of patients with ≥30% improvement from baseline in VC at the last visit during which a measurement was collected within 6 months of final CCH treatment. Adverse events are collected throughout the study period to assess safety. Results In this first look at early data, 32 eligible patients with a median age (range) of 58.0 years (25-75 years) were included in the analysis. The percent change in penile curvature from baseline decreased, representing an improvement of 45.4% (SD: 28.62 [0-100]) (Figure), with 68.8% (22/32) of patients experiencing ≥30% improvement from baseline in VC. There were no serious adverse events. Five patients had at least one treatment-related adverse event (TRAE); 4 TRAEs were mild-to-moderate in severity and 2 were unknown. There were no reports of urethral involvement or injury. TRAEs were related to injection site bruising (n = 3), hemorrhage (n = 1), swelling (n = 1), and muscle spasm (n = 1). Conclusions This first look at early data reflecting improvements in men with PD and VC (data cutoff: 06/14/2024) is consistent with findings of effectiveness and tolerability of CCH in the treatment of men with dorsal and dorsolateral penile curvature. 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: MZ is an investigator and consultant for Endo USA Inc. MI is an investigator for Endo USA Inc. AT is an investigator and consultant for Endo USA Inc. RB is an investigator for Endo USA Inc. JM is an investigator and consultant for Endo USA Inc. JT is an employee of Endo USA Inc. DH is an employee of Endo USA Inc. GK is an employee of Endo USA Inc. KG is an investigator and consultant for Endo USA Inc. JA is an employee of Endo USA Inc. TR is an employee of Endo USA Inc. MA is an employee of Endo USA Inc. JM is an investigator for Endo USA Inc.

Abstract Introduction Concerns exist when inflatable penile prosthesis (IPP) surgery is performed following transcorporal artificial urinary sphincter (TC-AUS) due to risk of damaging the AUS cuff during proximal corporal dilation and device placement. Aside from rare case reports, no data exists on outcomes and complications in patients who undergo IPP surgery with existing TC-AUS in place. Objective We aim to describe perioperative complications, infections, revision rates, and device longevity when IPP surgery is performed with existing TC-AUS in place. Methods A retrospective search was conducted to identify all patients who had undergone TC-AUS placement at a single institution from 2015-2023. Patients who had undergone IPP placement following TC-AUS at the same institution were identified. Operative technique for IPP placement was similar to standard IPP surgery with additional care taken to avoid the AUS device and preferential use of electrocautery over sharp dissection. Operatives notes and all patient encounters were reviewed, and data on demographics, operative details, perioperative complications, infections, revision rates, and device longevity were recorded. Results 727 patients underwent TC-AUS placement from 2015-2023. Of these, 13 patients underwent subsequent IPP placement (fig. 1). All patients had history of prostatectomy, and 6 (46%) patients had prior radiation. The median follow-up after IPP was 31.7 months and the time gap between AUS and IPP averaged 18.3 months (range 2.3 to 56.7 months). Average operative time for IPP was 85 minutes (range 53 to 202 minutes). Reservoirs were all placed contralateral to the AUS reservoir to minimize risk of injury to the AUS device. 8 patients had a 12 Fr catheter left post-operatively for less than 24 hours. Proximal dilation was noted to be difficult in 2 patients (15%), both of which were successfully dilated without perforation or damage to the AUS cuff. No infections or erosions occurred. 3 patients (23%) developed mechanical failure at a mean time of 28.7 months following IPP placement (36.5 months after AUS). Cuff leak was identified in 2 patients and the third has yet to undergo revision surgery to determine etiology. Conclusions IPP placement appears safe and effective in men who have previously undergone TC-AUS without increased risk of infection or device erosion. Care should be taken when dilating proximally, though proximal dilation was uneventful in most patients. Mechanical failure rates may be slightly higher compared to patients who have either device alone, and patients should be counseled accordingly. Disclosure No.

Abstract Introduction The utilization of rear tip extenders (RTE) is often imperative during Inflatable Penile Prosthesis (IPP) placement. The impact of RTE on perioperative morbidity of IPP surgery is underexplored. Objective In this study, we assess intraoperative and postoperative outcomes among patients undergoing primary IPP implantation with or without RTE. Methods We performed a multicenter, retrospective analysis of men undergoing primary IPP placement between July 2016 and July 2021. A total of 4308 patients were identified, of which 2963 had no RTE and 1345 had RTE. After 1:1 propensity score matching for all confounding variables, 840 patients without RTE were compared to patients with RTE for intraoperative and postoperative outcomes. Chi-square and Mann–Whitney tests were used for statistical analysis for categorial and continuous variables respectively. For multivariable analysis, we used a forward stepwise model and included significant variables found on preoperative characteristics of patients. Kaplan–Meier time to event analysis were compared with Mantel-Cox log-rank test. Results Patients with RTE use had more postoperative complications (9.6% vs 5.2%, p < 0.001). More specifically, RTE patients had more episodes of postoperative hematoma and bleeding (2.0% vs 0.7%, p = 0.033), device malfunction (2.7% vs 1.8%, p = 0.006), and glans-related complications (0.8% vs 0, p = 0.015). On multivariable analysis, use of RTE (OR 1.58, 95% CI 1.07-2.34, p = 0.021), AMS 700 series device (OR 1.93, 95% CI 1.27-2.94, p = 0.002), penoscrotal approach (OR 2.60, 95% CI 1.61-4.18, p < 0.001), and older age (OR 1.02, 95% CI 1.00-1.04, p = 0.035) were associated with increased risk of postoperative complications. Patients with RTE use had increased rate of postoperative IPP revision (5.0% vs 2.1%, p = 0.002). The use of RTE (OR 1.71, 95% CI 1.00-2.90, p = 0.046), AMS 700 series device (OR 1.73, 95% CI 1.01-2.97, p = 0.048), penoscrotal approach (OR 3.16, 95% CI 1.63-6.17, p < 0.001), and history of Peyronie’s disease (OR 2.24, 95% CI 1.31-3.82, p = 0.003) were associated with increased risk of postoperative IPP revision or explantation. On Kaplan–Meier analysis, use of RTE was associated with increased risk of postoperative complications and IPP revision or explantation within 48 months (log rank p = 0.001 and p = 0.002 respectively). Conclusions In this large multi-institutional cohort, patients with RTE experienced more hematoma, device malfunctioning, and glans related post operative complications. The use of RTE is an independent predictor of post-operative complications and IPP revision or explanation. Disclosure No.

Abstract Introduction Penile prosthesis (PP) implantation is associated with high patient satisfaction in patients with medically refractory erectile dysfunction (ED). There remains a paucity in the literature regarding the temporal evolution of patient satisfaction and well-being following PP surgery. Objective We aimed to identify factors responsible for patient satisfaction after surgery. Methods We initiated a registry of patients undergoing surgery for placement of a PP. After consent, perioperative study assessments and follow-ups were conducted. After surgery, patients were directed to a survey at 6 months and 12 months. Patients who completed both items were included in the analysis. Results A total of 304 patients had a PP placement, of these 101 completed the initial surveys. Overall patient satisfaction was favorable and durable and 6- and 12-months (87% and 82% respectively, p = 0.11). Confidence with device use was reported by 92% at 6 months, without significant change at 1 year (vs. 95%, p = 0.91). At 6 months, 81% of patients reported that their PP met or exceeded expectations, 83% of patients reported that they would undergo the procedure again, and 80% would recommend to a friend/family member. [Figure 1] At 6 months, 78 patients (77%) reported a moderate to high improvement in their overall sense of well-being related to their PP. This percentage further increased to 91% at 12-months (p < 0.001). Additionally, 36% of patients reported that they had made significant improvements to their overall lifestyle since receiving the PP, and this increased to 48% by 12 months post-operatively (p = 0.082). Conclusions Penile prosthesis satisfaction is evident and durable as early as 6 months following surgery. Factors such as perceived overall well-being continued to significantly improve past 6 months, and nearly half of patients reported overall lifestyle improvement following surgery. Disclosure Yes, this is sponsored by industry/sponsor: Coloplast. Clarification: Industry funding only - investigator initiated and executed study.