Köhler, Tobias

Abstract Background In 1999, 1 year after the approval of the first oral phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED), the first Princeton Consensus Conference was held to address the clinical management of men with ED who also had cardiovascular disease. These issues were readdressed in the second and third conferences. In the 13 years since the last Princeton Consensus Conference, the experience with PDE5 inhibitors is more robust, and recent new data have emerged regarding not only safety and drug–drug interactions, but also a potential cardioprotective effect of these drugs. Aim In March 2023, an interdisciplinary group of scientists and practitioners met for the fourth Princeton Consensus Guidelines at the Huntington Medical Research Institutes in Pasadena, California, to readdress the cardiovascular workup of men presenting with ED as well as the approach to treatment of ED in men with known cardiovascular disease. Method A series of lectures from experts in the field followed by Delphi-type discussions were developed to reach consensus. Outcomes Consensus was reached regarding a number of issues related to erectile dysfunction and the interaction with cardiovascular health and phosphodiesterase-5 inhibitors. Results An algorithm based on recent recommendations of the American College of Cardiology and American Heart Association, including the use of computed tomography coronary artery calcium scoring, was integrated into the evaluation of men presenting with ED. Additionally, the issue of nitrate use was further considered in an algorithm regarding the treatment of ED patients with coronary artery disease. Other topics included the psychological effect of ED and the benefits of treating it; the mechanism of action of the PDE5 inhibitors; drug–drug interactions; optimizing use of a PDE5 inhibitors; rare adverse events; potential cardiovascular benefits observed in recent retrospective studies; adulteration of dietary supplements with PDE5 inhibitors; the pros and cons of over-the-counter PDE5 inhibitors; non–PDE5 inhibitor therapy for ED including restorative therapies such as stem cells, platelet-rich plasma, and shock therapy; other non–PDE5 inhibitor therapies, including injection therapy and penile prostheses; the issue of safety and effectiveness of PDE5 inhibitors in women; and recommendations for future studies in the field of sexual dysfunction and PDE5 inhibitor use were discussed. Clinical Implications Algorithms and tables were developed to help guide the clinician in dealing with the interaction of ED and cardiovascular risk and disease. Strengths and Limitations Strengths include the expertise of the participants and consensus recommendations. Limitations included that participants were from the United States only for this particular meeting. Conclusion The issue of the intersection between cardiovascular health and sexual health remains an important topic with new studies suggesting the cardiovascular safety of PDE5 inhibitors.

Abstract Glans hypermobility (GH) is a well-described clinical entity that can have significant implications for cosmesis and function, resulting in sexual dissatisfaction, penile pain, and early device erosion, with an estimated incidence of 0.04–10%. We developed a novel grading scale to assess GH severity intraoperatively during primary inflatable penile prosthesis (IPP) placement and describe a modified glanspexy technique to correct GH when encountered during IPP placement. A total of 530 patients underwent primary device implantation. Of these, 139 (26%) had hypermobility. Employing our new scaling system, grade 1, 2, and 3 GH was seen in 86 (16%), 29 (5.5%), and 24 (4.5%) cases, respectively. Increased implant size correlated with decreased likelihood of GH incidence. Each increase in implant size by 1 cm decreased the incidence of detecting GH by 11% (OR = 0.89; p = 0.015). 11 patients underwent primary GH repair using our described technique. At one-year follow-up, one patient required repeat glanspexy for recurrent bothersome GH and a second patient developed a suture granuloma at the glanspexy incision requiring unilateral cylinder explant. Our modified glanspexy technique can be used to correct GH in any direction and is a useful tool for the prosthetic surgeon’s armamentarium.

Abstract Introduction Penile Implant reservoir complications continue to drive surgical technique innovation to avoid catastrophic complication typically affiliated with theoretical placement in the space of Retzius. The high submuscular technique (versus initially described low submuscular) aimed to reduce migration/herniation. Most high submuscular technique complications are cosmetic, however, unintentional bowel injury and difficulty with extraction of these reservoirs has been reported. Furthermore, reservoirs left via drain and retain technique have been reported to cause significant bowel complications most typically when the reservoir or pressure regulating balloon unknowingly resides intraperitoneally. Objective We report outcomes of two surgeons who independently invented and published novel techniques allowing for low submuscular reservoir placement (and thus avoid blind puncture above the arcuate line) to help avoid reservoir complications. Methods Two surgeons’ technique outcomes were assessed. The first surgical technique (T1) involves suturing an additional implant connector collar to the pubic bone with a permanent stitch. This collar acts as a backstop to prevent reservoir herniation or migration into the scrotum. It can also be used to prevent upward migration of drain and retain reservoirs as the retained reservoir is capped. The second surgical technique (T2) involves placing a right angle outside in of the fascia after a pocket is cleared below the muscle and pulling the implant tubing through this defect. This approach stops the prb or reservoir at the puncture site. Results T1 was performed 55 times for reservoir fixation and 7 times for drain and retain fixation. Mean follow up is 11 months. One infection occurred necessitating reservoir removal (and cutting of permanent stitch) which was easily accomplished. No other complications or patient complaints from this technique have occurred. Average case time increase is 5-10 minutes. T2 has been performed 31 times for reservoir fixation with no complications or patient complaints. Average case time increase is < 5 minutes. Conclusions Although submuscular reservoir techniques decrease catastrophic complications and are widely adopted, they are not without risk. We report success of two independent techniques that demonstrate safety and feasibility with low reservoir placement. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Mayo Clinic – Rochester

Abstract Introduction We report outcomes for patients in which the IPP became unusable by the patient because of pump difficulties or inadequate fluid volume in the IPP system. Objective We sought to assess outcomes of penile implant single component exchange or fluid instillation in a cohort of patients, challenging the entire device replacement dogma. Methods 17 patients underwent single component exchange by a single surgeon. CT scan was obtained to ensure device integrity, assess for air in the system, and to delineate device details. In cases of pump difficulties, the old pump was removed and replaced with a “classic” Genesis Coloplast pump regardless of initial device brand (“Frankenstein” if brands are mixed). Patients are taught pump rocking techniques and have > 6 months of difficulty before exchange. Patients are warned of auto-inflation as there is no lock out valve in the Genesis pump. For fluid addition to the system, the two old connector collars are separated and sometimes re-used after saline is added to only the cylinders. We never add fluid to the reservoir using a piston syringe for fear of reservoir capsule rupture into adjacent structures. Revisions were copiously irrigated, as of 2022, with Irrisept. Results Pump exchange: 14 patients underwent single component pump exchange secondary to inability for the patient to be able to adequately cycle the device (11 AMS MS, 1 Coloplast Touch). Remarkable differences were noted in pump cycling between office exam (difficult), exam under anesthesia prior to incision (sometimes difficult), and once the pump is removed from its capsule (universally easy). Complications of these 14 patients include 1 fungal infection requiring replacement with a malleable device and one repeat pump exchange (AMS MS - AMS MS - Genesis). Two patients noted non-bothersome minor auto-inflation. The single Coloplast case had a remarkably thickened capsule after a likely low grade infection. All patients can successfully use their devices now. Fluid Addition: Three patients underwent fluid addition to the system. One had a significant proximal aneurysm for which we added 35 ml. A different case had both a pump exchange and 30 ml added to the system as the initial reservoir appeared to have folded cordoning off fluid. The final fluid addition occurred 18 months after initial Coloplast 22+2 cm placement in which the patient very aggressively cycled the device and could not obtain 10/10 erection. 30 ml was added to the system totaling 140 cc. All patients have done well with fluid addition with mean time since surgery of 1 year. Conclusions Pump exchange with genesis pump or simple fluid addition to the system are safe and feasible and successfully restores IPP functionality. The Frankenstein strategy is a viable alternative, although patients must be counseled that auto-inflation may occur. With modern day irrigation techniques and CT confirmation of fluid system integrity, the dogma to replace the entire device may actually carry higher morbidity in some patients. Disclosure No

Abstract Introduction Erectile dysfunction (ED) stems from a variety of etiologies and often requires a multidisciplinary approach to optimize patient care. Objective We sought to assess attitudes and confidence regarding the treatment of erectile dysfunction across different provider types. Methods Responses were obtained through an anonymous, email-based survey of our institution's providers in the disciplines of urology, internal medicine, and family medicine. We created a novel tool of 25 5-point Likert scale questions regarding ED treatment. Data were analyzed through descriptive statistics and Fisher’s exact test and sorted by respondent specialty. Ethical Committee approval was obtained before study. Results 138 health care providers returned surveys, including 58 internists (IM), 47 family physicians (FP), and 33 urologists (GU). FP and IM responses showed significant overlap with a few key statistically significant differences. In general, IM was much more positive in VED, penile implant as an option, penile implant satisfaction, and penile implant risk. 37% of IM agreed or strongly agreed inflatable penile prosthesis risk is low vs 6% FP (p = .0032). IM also more strongly supported team-based care and referral to specialists IM 71% vs. 51% FP (p = .0012). (Figures) When comparing GU versus FP + IM 24/25 questions revealed statistically significant differences revealing greater GU confidence and knowledge about ED with only the importance of a team-based approach not differing. Noteworthy points include 46% vs. 18% confidence for a detailed sexual history for GU vs. FP + IM (all other points % and same provider sequence). IIEF usage and familiarity were 61 vs. 3 and 88 vs. 18, respectively. 100 and 85 strongly/agreed that good options remained after pills failed. Regarding inflatable penile prosthesis, agreement or strong agreement for patient willingness to undergo surgery for ED 67 vs. 13; patient satisfaction 91 vs. 25, partner satisfaction 80 vs. 25; and would repeat surgery or recommend to a friend was 82 vs. 17. Finally, and perhaps most notably 83 vs. 11 of providers were aware that Medicare covered implants. (Figures). Conclusions Conclusions This survey reveals significant knowledge gaps for treatment options and outcomes for ED. Targeted provider education, particularly about penile prostheses, could optimize patient care. Disclosure No

Abstract Introduction Penile prosthesis placement in men on active anti-coagulation (AC) is controversial. The bleeding risk of continued blood thinners must be weighed against the increased thrombotic risk for patients when stopping them. Previously utilized techniques to decrease complication rates from AC include the use of a malleable implant only, leaving the IPP partially inflated for hemostasis, and placement of a drain. Objective We sought to assess outcomes of penile implant placement in men on clopidogrel, warfarin, apixaban, enoxaparin, and rivaroxaban in a multi-institutional study. Methods Data from 3 high volume implant centers were retrospectively obtained. Demographic characteristics, comorbidities, case information including secondary procedures, placement of drain, drain output, and complications were recorded. Data on patients with aspirin any dose alone were not included as all 3 centers do not routinely discontinue ASA at time of penile implant. One center never placed drains and used a penoscrotal approach, one center left a drain at least one day and removed when output was < 50 ml/8 hours and used a penoscrotal approach, and the last center placed a drain for 3 days and utilized an infra-pubic approach. Results 202 patients were continued on AC throughout surgery. 112 patients were on clopidogrel, 35 warfarin, 38 apixaban, 1 enoxaparin, 15 rivaroxaban, and 1 on combination therapy with clopidogrel and enoxaparin. AC requirement included peripheral vascular disease (55%), CHF (11%), cardiac stents (11.6%), DVT/PE/history of thrombosis (7%), atrial fibrillation (11%), cardiac valves (2.2%), stroke (1.3%), and preventive (0.9%). Nine patients on AC (3.98%) experienced complications including 4 significant events (1.9%): 1 major retropubic bleed requiring transfusion, 3 IPP infections and 5 minor events: 3 minor hematomas, 1 minor wound dehiscence and 1 CT negative stroke event. Drain outputs for the 3 day center averaged 113 ml, 81 ml and 30 ml of output per day respectively with a total average output average of 223 ml and experienced no hematomas nor infections. Drain output for the center with removal when < 50 ml/8 hours averaged 121 ml with the majority or patients having the drain for only one day. Drain output was significantly higher than historical non AC controls (121 vs. 72 ml p=.001) but there was no difference in hematoma rate. Three hematomas and 1 infection occurred in this group. AC type, revision surgery, scrotoplasty, or reservoir technique did not affect outcomes nor drainage (P>.05). Complication rate (IPP infection and hematoma rate) where not different when compared to large cohorts from respective institutions. Conclusions Our data shows a 1.9% rate of major complications in patients undergoing IPP placement on anticoagulation in high volume implant centers. Although this approach appears feasible and similar in complication rates in men not on AC, careful consideration of the risk benefit ratio should be undertaken. Our data indicate closed suction draining for 3 days may be warranted. Additionally, the retropubic bleed case argues for only submuscular reservoirs placed under direct vision which minimizes occult bleeding risk. In the majority of cases, elective IPP surgery should be delayed until it is safe to discontinue anticoagulation therapy. Disclosure No

Abstract Introduction Inflatable penile prosthesis reservoir herniation or migration may occur with space of Retzius or submuscular placement. The dangers of high submuscular placement include bowel or bladder perforation (from blind instrument passage) and or bowel herniation (from unintentional peritoneal placement and stretching of small opening with reservoir filling). Even under direct vision submuscular placement, reservoirs can ultimately reside into the scrotum, retroperitoneum, and lateral abdominal wall. The Transfascial Fixation (TFF) technique was recently developed to prevent reservoir migration with placement either submuscularly or in the space of Retzius, but video of this technique has not been previously published. Objective To visually demonstrate the proper surgical technique of TFF during IPP reservoir placement. Methods An IPP surgical candidate at high risk of complications should reservoir migration occur was identified. Video of TFF technique performed during IPP surgery was recorded using an in-light overhead camera and a GoPro aseptically positioned on the lead surgeon. Results Successful demonstration of TFF technique during IPP placement. Conclusions TFF technique is a feasible option to aid prevention of penile implant reservoir herniation. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Boston Scientific, Metuchen Pharmaceuticals, Acerus Pharmaceuticals, Endo Pharmaceuticals, AbbVie Inc.

Abstract Introduction Penile duplex Doppler ultrasound (PDDU) is an important test to diagnose and guide treatment recommendations for peyronie’s Disease and erectile dysfunction. When patients do not achieve optimal rigidity during their evaluation we may be underestimating their degree of curvature and erection response which can impact treatment recommendations. Objective To evaluate specific examination conditions that may negatively impact the patient experience in men undergoing PDDU. Methods We developed a survey to evaluate patient experience during PDDU. Specific questions addressed preferences regarding the type of clinician performing the examination (physician versus advanced practice provider), provider gender, and specific modifiable conditions about the examination room. The survey was administered to thirty-five consecutive patients at a single academic practice. Patients were asked to complete portions of the survey before and after the examination to limit bias. Results 113 patients completed the survey. Prior to starting the testing, 48% of patients (n=54) had no provider preference, whereas 43% (n=49) preferred a physician as the performing clinician. 70% of patients (n=79) had no provider gender preference. All patients received at least a single dose of intracavernosal erectogenic medication at the start of their assessment. After completing PDDU, 40% of patients (n=45) reported that room conditions negatively impacted their ability achieve an adequate erectile response in the clinic. As shown in Figure 1, bright fluorescent overhead lighting (29%) and hallway noise (21%) were the most frequent contributing factors. When asked about opportunities to improve future patient experience, 38% (n=43) recommended dimming the room lights, 31% (n=35) would enjoy a warm blanket, and 36% (n=41) would favor gentle music or background sounds. 32% (n=36) felt that using call button, as opposed to routine staff checks to verify erectile response, would be desirable. Despite these preferences, the mean overall patient experience on a scale of 0-10 (0=poor, 10=excellent) was high at 9.3 (SD 1.2). Conclusions Despite high patient-reported satisfaction, we found that patients undergoing PDDU for PD and ED reported a preference towards (i) softer/dimmer lights, (ii) sound machine to drown out hallway noise, (iii) aa warm blanket, (iv) a call system to alert staff of a satisfactory erectile response. Further investigations are necessary to determine whether these simple modifications can improve the patient experience and exam efficiency. Disclosure No