Citations

Abstract Background Variations in climate have been associated with a greater risk of surgical site infections, urinary tract infections, and changes in the skin microbiome; however, limited data exist on the impact of climate on inflatable penile prosthesis (IPP) infections. Aim We sought to evaluate the impact of climate on the risk of IPP infections in a large international, multicenter cohort. Methods We performed a multi-institutional, retrospective study of patients undergoing IPP surgery. We then evaluated whether the month or season, during which surgery was performed, affected device infections. Implant infections were defined as infections requiring device explantation. A univariate logistic regression analysis was undertaken. Outcomes Our primary outcome was implant infection. Results A total of 5289 patients with a mean age of 62.2 ± 10.8 years received IPP placement. There was a fairly even distribution of implants performed in each season. A total of 103 (1.9%) infections were recorded. There were 32 (31.1%) IPP infections in patients who underwent surgery in the summer, followed by 28 (27.2%) in the winter, 26 (25.2%) in the spring, and 17 (16.5%) in the fall. No statistically significant differences were recorded in terms of season (P = .19) and month (P = .29). The mean daily temperature (P = .43), dew point (P = .43), and humidity (P = .92) at the time of IPP placement was not associated with infection. Clinical Implications These findings provide reassurance to prosthetic urologists that infection reduction strategies do not need to be tailored to local climate. Strengths and Limitations Climate data were not directly recorded for each hospital, but rather based on the monthly averages in the city where the surgery was performed. Conclusion The climate at time of IPP placement and time of year of surgery is not associated with IPP infection risk.

Abstract Introduction Microdenervation of the spermatic cord (MSCD) is an effective treatment modality for men with intractable scrotal content pain. For patients not interested in preserving fertility, some centers advocate ligation of the vas during denervation while others perfer stripping of the Vas deferens to preserve the vasal artery, hence preserving vasculature to testis and possibly decreasing post operative congestion pain. Objective This multicenter study analyzes outcomes of patients that underwent MSCD by either stripping or ligating the vas deferens. Methods A retrospective chart review of 85 patients who underwent MSCD from 2020–2023 was performed. Patients’ demographics including history of prior surgical procedures was recorded. Response to surgery was evaluated as either complete resolution of pain, partial resolution of pain or no improvement in pain. Results 85 patients underwent MSCD with a median (IQR) age of 36 (25.5–46.5) years and median duration of pain of 16 months. 37 patients underwent stripping of vas while 48 underwent ligation of vas during MSCD. Median follow up was 12 months. 21(43.5%) patients had prior inguinal scrotal surgery in ligation group compared to 5 (13.5%) in the stripping group p=0.003. The etiology of pain was similar between the groups. The response to MSCD between the 2 groups was similar (p=0.968), with similar post op complications (Table 1). Conclusions In men with intractable chronic scrotal content with no interest in preserving fertility, ligation or stripping of the vas deferens yields similar outcomes with regards to pain resolution. Both techniques are safe with no reports of any testicular atrophy. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Advisory board and speaker for Coloplast; consultant for Cynosure; advisory board and speaker for Halozyme; intellectual property with Masimo; advisory board for Promescent; consultant for Sprout; advisory board for Xialla.

Abstract Introduction Intracavernosal injection (ICI) therapy for erectile dysfunction (ED) carries a risk of corporal fibrosis, potentially making placement of an inflatable penile prosthesis more difficult. Prostate cancer treatment may also induce corporal fibrosis. Objective To assess whether a history of ICI or prostate cancer treatment is associated with complications following IPP placement. Methods A retrospective cohort study of primary IPP cases from 2016–2021 across 16 institutions. Patients were stratified by history of ICI and between-group differences in risk factors were assessed. Multivariable logistic regression was used to assess for predictors of intraoperative complications, postoperative non-infectious complications and postoperative infection. Results A total of 2540 patients met inclusion criteria of which 781 (30.8%) had a history of ICI. Patients with a history of ICI tended to be older (mean 63 vs 64 years, p=0.002) and were more likely to have history of radical prostatectomy (21.0% vs. 32.1%, p<0.001) and/or radiation (5.51% vs 10.9%, p<0.001). On multivariable regression, a history of ICI, prostatectomy, and radiation were all significant predictors of intraoperative complications (OR 2.11, p=0.03; OR 2.27, p=0.03; OR 2.40, p=0.04, respectively). A history of ICI and patient age were predictors of non-infectious postoperative complications (OR 1.44, p=0.02, OR 1.02, p=0.004 respectively)). None of the variables were significant predictors of infection. Conclusions In men undergoing IPP placement, a history of ICI is associated with an increased risk of both intraoperative and postoperative, non-infectious complications. Prostate cancer treatment with radiation or surgery is independently associated with increased risk of intraoperative complications. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: D.O. has served as a consultant for Coloplast, Intuitive Surgical, and Fidelis. P.P. has served as a consultant for Coloplast, Boston Scientific, and Urofill. M.S. has served as a consultant for Boston Scientific and Coloplast. J.S. has served as a consultant for Boston Scientific and Coloplast. F.A.Y. has served as a consultant for Coloplast, Cynosure, Antares Pharma, Clarus Pharmaceuticals, and Acerus Pharma. M.S.G. has served as a consultant for Coloplast. The other authors disclose no conflicts.

Abstract Introduction Limited data are available on the efficacy of collagenase clostridium histolyticum (CCH) on Peyronie’s disease (PD) in men with ventral curvatures. Our team previously published a limited series of outcomes of 25 men with ventral curvatures who underwent CCH. Given the paucity of data available, we sought to provide an updated series of outcomes in this important cohort. Objective To report outcomes of men undergoing CCH injections for PD based on initial direction of curvature, including absolute and percent improvement in curvature, adverse events (AE), and other subjective outcomes. Methods A prospective registry has been maintained of all men undergoing CCH injections since 2014. All men underwent curvature assessments and subjective questioning at the time of initial evaluation and prior to each subsequent series of injections. The method of injection and subsequent protocol have changed in a stepwise fashion since 2014 and currently include injecting 0.9 mg (diluted to 0.8 mL) on back-to-back days, injecting into the point of max curve with an erection on day 1, performing in-office modeling on day 2, utilizing Restorex traction beginning on day 2, and wrapping for 4-8 days depending on results. To review outcomes, clinicopathologic data were abstracted from the registry including relevant history, exam, and data obtained at the time of penile ultrasound and curvature assessment. Outcomes are reported using a “Most Recent” definition (most recent data point used, regardless if the patient continues or finished treatment) and “Completed 8 or Satisfied” (only included if the patient indicated that they were done with treatment or had finished the full 8 injections). Results A total of 560 patients (mean age 57 years) were identified from March 2014 through Feb 2023 and comprise our study cohort. Overall, 85 men had a ventral component to their curvature and 475 non-ventral. Baseline demographics and clinical factors were similar between groups, with the exception of penile length (ventral 14.0 cm, non-ventral 12.0 cm, p<0.0001), Psych and Physical subdomain of the Peyronie’s Disease Questionnaire (10 vs 12, p=0.03), and prior treatment with CCH (3% vs 16%, p=0.03). Following treatment, men in the ventral cohort exhibited possibly greater improvements in curvature (Most Recent Definition: -25 degrees vs -24, p=0.08; 45% vs 34%, p=0.03; Completed 8 or Satisfied Definition: -35 vs -25, p<0.05, 48% vs 38%, p=0.11). However, all other outcomes were similar between cohorts, including differences in subdomains of the IIEF and PDQ, use of traction therapy, and adverse events including ecchymoses, hematomas, and popping sensations. Importantly, no urethral complications were experienced in the ventral group. Conclusions Men with ventral PD may be effectively treated with CCH with similar AEs compared to other directions. Ventral curvatures are likely associated with greater overall curvature improvements compared to other directions. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Endo - Matt Ziegelmann.

Abstract Introduction Since the FDA approval of Collagenase Clostridium Histolyticum (CCH) for the treatment of Peyronie’s Disease (PD), there has been significant debate as to its role and comparable efficacy in relation to surgical therapies. We have previously published results comparing the two therapies at 3-months post-treatment. Objective To compare various objective and subjective outcome measures at 12-months post-treatment between men undergoing CCH or surgery for PD. Methods A randomized, controlled trial (NCT04786106) is ongoing. Participants were randomized 1:1 to receive either CCH + traction (RestoreX) + sildenafil or penile surgery (plication and/or incision and grafting) + traction + sildenafil for PD. Objective, standardized (International Index of Erectile Function [IIEF] and Peyronie’s Disease Questionnaire [PDQ]), and non-standardized assessments were obtained at baseline, and post-treatment at 3, 6, 12, 24, 36, 48, and 60 months. Key outcomes included differences in standardized questionnaires, penile curvature, penile length, subsequent interventions, and non-standardized questionnaire responses. Curvature was measured in two planes and summed to provide a composite curvature. Penile length was measured from pubic symphysis to corona. All adjunctive therapies were stopped at 3-months post treatment completion (i.e., traction and sildenafil). Results A total of 40 men were randomized, with 38 completing treatment and 12-month data available on 28 men (CCH=12, surgery=16). Mean age at enrollment was 54.7 years, PD duration 37.4 months (mo), composite curvature 73.1 degrees (deg), and penile length 12.7 cm. All baseline variables were statistically similar between cohorts. Regarding primary outcomes, at 12-months post-treatment, CCH men reported being very satisfied 36%, satisfied 27%, and neutral 36% with none dissatisfied. Men in the Surgery cohort reported 14% very satisfied, 64% satisfied, 0% neutral, and 21% dissatisfied (p<0.01). For secondary outcomes, the median differences between CCH and Surgery were: IIEF-EFD (+2.0 vs +2.0, p=0.82), PDQ-physical (-5 vs -5, p=0.77, note, lower is better for PDQ scales), PDQ-pain (-1 vs 0, p=0.92), PDQ-bother (-7 vs -3, p=0.12), length change (+1.0 vs -0.13 cm, p<0.05), curvature absolute change (-37.5 vs -53.8 degrees, p=0.17), and curvature % improvement (55% vs 82%, p=0.15). Compared to 3-month data, Surgery men experienced greater curve recurrence (objective: Surgery +5 degrees vs -5 degrees CCH, p<0.05), decreased subjective penile length 62% vs 9% CCH (p<0.01) and decreased sensitivity (54% vs 27% CCH, p<0.05). Both groups reported similar rates of improved sexual function (CCH 82% vs 64%, p=0.30) and change in erectile function (CCH 55% improved, 9% worsened; Surgery 62% improved, 8% worsened, p=0.53). Both groups were also equally satisfied with their curvature (CCH 55% vs Surgery 54%, p=0.97), despite greater overall curve improvements in the Surgery arm. 75% of CCH men reported improved indentation/hourglass vs 56% Surgery, p<0.05. Both groups reported similar rates of being willing to do their treatment again (CCH 73% vs 77%, p=0.64), while 91% of CCH men would recommend it to a friend vs 77% Surgery (p=0.35). Conclusions Preliminary data suggests that when compared to surgery at 12-months, CCH men were more likely to be very satisfied, experience penile length increases, and less likely to experience dissatisfaction, curvature recurrence, and decreased penile sensation. 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: Matthew Ziegelmann - Endo Pharmaceuticals.

Abstract Introduction Climacturia, the inadvertent leak of urine during orgasm, is a well-known complication following radical prostatectomy and can cause significant patient/partner bother. The Mini-Jupette sling treats climacturia during placement of an inflatable penile prosthesis (IPP) but requires an extended corporotomy with a complex closure. Our modified Mini-Jupette technique utilizes a standard corporotomy and places the sling inferior as opposed to integrated into the corporotomy. Additionally, we perform an intraoperative drip test for urethral occlusion, which eliminates the need for guessing on sling tension. Corset sutures can then be utilized intraoperatively or in future revision surgeries in the event of sling loosening or recurrent climacturia. Objective To visually demonstrate the modified mini-jupette technique and intraoperative drip test. Methods An IPP surgical candidate with climacturia was identified. Intraoperative video of the Mini-Jupette technique was recorded using an overhead camera. The Mini-Jupette sling is placed with four vertical Ethibond (00) sutures placed inferior to the corporotomy stay sutures. The drip test is set up by retracting the catheter to the distal urethra and connecting it to a bedside irrigation system set 60cm above the patient. Stoppage of fluid flow during IPP inflation indicates that the sling is appropriately occluding the urethra. Results Successful demonstration of a modified Mini-Jupette technique and intraoperative drip test without complications. Conclusions Our modified Mini-Jupette and intraoperative drip test provide a reasonable alternative to the standard Mini-Jupette technique. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast.

Abstract Introduction Peyronie’s disease is characterized by penile plaque or scar within the tunica albuginea. This results in penile deformity, most commonly penile curvature but also volume loss deformity such as hourglass or indentation. This volume loss occurs in up to 65% of men with Peyroine’s disease. Surgical management for patients with significant deformity includes plaque incision/partial excision and penile grafting with an absorbable grafting material. In the original description of extra-tunical grafting, the grafting material was placed over Buck’s fascia via a ventral longitudinal incision. In our modified technique, the grafting material is placed under Buck’s fascia and superficial to the tunica albuginea, which allows the grafting material to be less palpable in the flaccid condition. Objective To demonstrate a modified approach to Extra-Tunical Grafting for peyronie’s disease indentation deformity. Methods Intra-operative video of modified extra-tunical grafting was recorded with an overhead surgical camera. Results Successful modified extra-tunical grafting with excellent penile straightening and restoration of penile girth and minimal palpability of the graft. Conclusions Our modified extra-tunical grafting technique is a reasonable option compared to the standard grafting technique Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast.

Abstract Introduction Radiation therapy (RT) can predispose the onset of corporal fibrosis and microvasculopathy. The impact of RT on intra-operative complications is not well described in the literature. Objective In this study, we assess intra-operative and post-operative outcomes among patients with or without prior history of RT following primary Inflatable Penile Prosthesis (IPP) implantation. Methods We performed a multicenter, retrospective analysis of men undergoing primary IPP placement between January 2015 and December 2022. A total of 3530 patients were identified, of which 3319 had no prior history of RT and 211 patients had history of RT. After 1:1 propensity score matching for all confounding variables, 211 patients with a history of RT were compared to 211 nonradiated patients for intra-operative and post-operative 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 pre-operative characteristics of patients. Kaplan-Meier time to event analysis were compared with Mantel-Cox log-rank test. Results Patients with history of RT encountered more intra-operative complications (4.3% vs 0.9%, p=0.032); specifically, these men experienced more distal crossover events (1.9% vs 0, p=0.044). On multivariable analysis, history of prior RT (OR 5.29, 95% CI 1.07-26.3, p=0.041) and diabetes mellitus (OR 10.5, 95% CI 2.58-43.5, p=0.01) were associated with increased risk of intra-operative complications. History of obesity (OR 0.11, 95% CI 0.01-0.91, p=0.040) reduced risk of intra-operative complications. There was no significant difference in early or late post-operative non-infectious complications between both groups and there was also no significant difference in risk of post-operative complications within 24 months on Kaplan Meier analysis (log rank p=0.9). Conclusions In this large multi-institutional cohort, history of RT is an independent predictor of intra-operative complications but not post-operative complications during primary IPP placement. These findings may help inform patient-specific counseling while guiding surgical planning to prevent untoward morbidity following surgery. Disclosure No.

Abstract Introduction Intracavernosal injection (ICI) therapy for erectile dysfunction (ED) carries a risk of corporal fibrosis, potentially making placement of an inflatable penile prosthesis more difficult. Prostate cancer treatment may also induce corporal fibrosis. Objective To assess whether a history of ICI or prostate cancer treatment is associated with complications following IPP placement. Methods A retrospective cohort study of primary IPP cases from 2016-2021 across 16 institutions. Patients were stratified by history of ICI and between-group differences in risk factors were assessed. Multivariable logistic regression was used to assess for predictors of intraoperative complications, postoperative non-infectious complications and postoperative infection. Results A total of 2540 patients met inclusion criteria of which 781 (30.8%) had a history of ICI. Patients with a history of ICI tended to be older (mean 63 vs 64 years, p=0.002) and were more likely to have history of radical prostatectomy (21.0% vs. 32.1%, p<0.001) and/or radiation (5.51% vs 10.9%, p<0.001). On multivariable regression, a history of ICI, prostatectomy, and radiation were all significant predictors of intraoperative complications (OR 2.11, p=0.03; OR 2.27, p=0.03; OR 2.40, p=0.04, respectively). A history of ICI and patient age were predictors of non-infectious postoperative complications (OR 1.44, p=0.02, OR 1.02, p=0.004 respectively)). None of the variables were significant predictors of infection. Conclusions In men undergoing IPP placement, a history of ICI is associated with an increased risk of both intraoperative and postoperative, non-infectious complications. Prostate cancer treatment with radiation or surgery is independently associated with increased risk of intraoperative complications. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: D.O. has served as a consultant for Coloplast, Intuitive Surgical, and Fidelis. P.P. has served as a consultant for Coloplast, Boston Scientific, and Urofill. M.S. has served as a consultant for Boston Scientific and Coloplast. J.S. has served as a consultant for Boston Scientific and Coloplast. F.A.Y. has served as a consultant for Coloplast, Cynosure, Antares Pharma, Clarus Pharmaceuticals, and Acerus Pharma. M.S.G. has served as a consultant for Coloplast. The other authors disclose no conflicts.

Abstract Introduction Limited data currently exist on the role and efficacy of additional series of collagenase clostridium histolyticum (CCH) injections among Peyronie’s disease (PD) men who have previously failed a first series of injections. We have previously published outcomes of men undergoing a novel protocol for CCH injections and which demonstrated significant improvements compared to original IMPRESS I and II techniques. We therefore sought to evaluate results of men who had previously failed CCH injections to determine if they would respond to a repeat course using a more aggressive protocol. Objective To evaluate outcomes of a novel protocol for CCH injections among men who had previously failed 6-8 CCH injections using a traditional approach. Methods A randomized, controlled trial (NCT05108558) is ongoing. All participants had previously failed to achieve ≥20% curvature improvement with 6-8 prior CCH injections. Men were randomized 3:1 to receive either CCH + traction (RestoreX) + sildenafil (treatment) up front or initial observation followed by treatment (controls). Outcomes were compared between treatment and control groups. Key measures included objective curve improvements and standardized/non-standardized questionnaires, with assessments obtained at baseline, 6-weeks after completion of CCH (treatment arm), after the no treatment period (controls), and at 1 year. Results A total of 22/40 men have been randomized to date, with 11 having fully completed treatment. Mean age was 64 years, with a median PD duration of 24 months. Mean composite baseline curvature was 80 degrees, with 55% having hourglass or indentation deformities, 10% calcification, median baseline IIEF-EFD 15, and 60% able to have penetrative intercourse. Median estimated improvement with the prior CCH series was 0% (IQR 0, 19.4), and the median number of prior injections was 8. The majority of men were dissatisfied with their prior series of CCH (60% vs 30% satisfied, 10% neutral). Of the 11 men who had completed the study protocol, 64% required 1 series, 9% 2 series, 18% 3 series, and 9% 4 series. Compared to the no treatment arm, treated men experienced significantly greater improvements (mean 78 degree vs 15, p=0.01). IIEF-EFD was also improved more in treated men (+4.3 vs -5.7, p<0.05). 100% of men reported a subjective major improvement in curvature, with the average subjectively estimated improvement 91%. 67% reported improved sensitivity (33% no change), while 60% reported improved or no change in erectile function, with 20% unsure, and 20% somewhat worse. Post-treatment, 83% of men were very satisfied with CCH as a treatment and 17% somewhat satisfied. Conclusions Repeating CCH using a novel protocol after an initially unsuccessful course of CCH achieves significant improvements in curvature and patient satisfaction. Additional data, including external validation, are warranted. 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: Matthew Ziegelmann - Endo Pharmaceuticals.