Roshandel, R

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 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 There is no agreed-upon definition for acute/chronic phases of Peyronie’s Disease (PD). Collagenase Clostridium histolyticum (CCH) is the only FDA-approved treatment for PD, but original phase-3 trials included patients with symptom duration > 12 months (“chronic phase”). Objective Here, we sought to evaluate the influence of time between symptom onset and starting CCH on treatment outcomes. Methods Men receiving CCH from 2014-2021 were included in an IRB-approved database. Pertinent data were reviewed, including demographics and curvature assessments. The duration between symptom onset and starting treatment with CCH was assessed to determine if the time from symptom onset to treatment impacted objective outcomes. Results One hundred forty-five patients completed the entire series of 8 injections and had complete data for review. Mean baseline curvature 53.2o (SD 18). The mean time between symptom onset and CCH was 14.8 months (SD 18). Mean absolute and percentage improvements were 20.3o (SD 16) and 39.4% (SD 35). Symptom duration did not significantly impact curvature improvement (Figure 1). Similarly, symptom duration did not significantly impact the risk for CCH-related side effects. Conclusions The time between symptom onset and treatment did not significantly impact outcomes with CCH. Our findings support the utility of using CCH early in the course of PD and emphasize the opportunity to delay if necessary without compromising efficacy. Disclosure No

Abstract Introduction Intralesional Collagenase Clostridium histolyticum (CCH) is approved for men with Peyronie’s Disease (PD). Most studies use curve improvement ≥ 20% to define treatment success. Objective Here, we sought to further characterize objective and subjective treatment outcomes with CCH. Methods We reviewed our prospectively maintained database for all patients who underwent CCH at our institution from 2013 through the present. We specifically identified those who completed four series of CCH (or elected to discontinue prior to completing four series due to satisfactory penile straightening or lack of results) and had available curvature assessment data. Treatment outcomes were broken down by level of curve improvement (0%, 10%, 20%, 30%, and > 40% improvement). Treatment success was also evaluated by improvements in the ability to engage in penetrative sexual intercourse and perceived surgery avoidance. Statistical analyses were performed using JMP Pro 14.1.0 (SAS Institute, Cary, NC). Results 127 patients had complete data available. The mean age was 57 years (SD 8.4). The mean PD duration was 27 months (SD 59). The mean baseline curvature was 66.1O, and the mean post-treatment curvature was 45.1O (p<0001). The mean curvature improvement was 32% (SD 33). 68% of patients achieved a 20% or greater improvement in penile curvature, including 38% who achieved ≥ 40% improvement. 72% (n=48/67) felt that CCH prevented the need for surgery, and 68% reported CCH restored the ability to penetrate. Stretched flaccid penile length (SPL) increased by ≥ 1 cm in 50% of patients who used concurrent penile traction (PTT) and CCH, including 28% of patients who experienced ≥ 2 cm of length gain. In contrast, only 16% of patients who did not perform concurrent PTT had a ≥ 1 cm increase in SPL (p<0.0001). Conclusions CCH may restore the ability to penetrate with intercourse, and most patients feel that CCH prevents the need for surgery. Almost 40% of patients experienced a 40% or greater curvature improvement. However, 13% of patients may go through the entire series with minimal improvement. Concurrent PTT allows for simultaneous penile length gain in some patients. These data are helpful when counseling patients on expected outcomes. Disclosure No

Abstract Introduction Penile dysmorphophobia is common, with up to 20% of men reporting dissatisfaction with their genital size. The global market for Sexual Enhancement Supplements is estimated at $300 Million in the year 2020 and is projected to reach $608 Million by 2027 in the US alone. Evidence for efficacy is minimal, and purported claims are hyperbolic. Objective We sought to assess penile elongation internet offerings, quantify cost, ingredients, and risk and investigate scientific literature of product ingredients when available. Methods Three online marketplaces (Amazon, Google market, and Walmart) were queried for dietary supplements available without a prescription to improve penile size. Product labels were reviewed to compile penile size-related claims and active ingredients. The one-course (60-day) cost of treatment and consumer star rating were assessed. MEDLINE, Web of Science, and Google Scholar were queried with labeled ingredients to assess the scientific evidence from published and lay sources. Results A total of 84 dietary supplements claimed either increased penile length, girth, enhanced sexual performance, or a combination thereof. Of these 84 products, 90 ingredients were listed. The Mean 60-day cost was $52 (range of $12–$222). The median score by consumers in the markets with a possibility of star rating was 3.5 (range 2.4-4.2) with obvious repetitive and self-promotional tactics. Unsurprisingly, no scientific evidence supporting change in penile size was found for any products in our search. Actual described physiologic activity from active ingredients included were described as antidepressant, lipid and glucose lowering/metabolizing, blood pressure effecting, anti-inflammatory, renally protective, cognitive function effecting, antioxidant, and several ingredients weakly enhancing erectile activity. Renal failure, warnings against long-term use, heart problems, neuropathy, blood pressure effects, fertility toxicity, bleeding, liver disease, and numerous interactions with diabetes, blood thinning, immunosuppressant, and PDE5 medications were found for the ingredients. Conclusions Dietary supplements claiming to enhance penile size contained ingredients with conflicting or no scientific evidence to support their claims. Several ingredients were dangerous. Clinician awareness of these sham “solutions” and their continued mass consumption highlight the magnitude of misinformation, unrealistic expectations, shame, and enhancement desperation regarding penile size in the male public psyche. Disclosure No

ABSTRACT Introduction Chronic pelvic and/or genital pain is a disabling condition and commonly associated with poor quality of life, impaired sexual function and decreased productivity. Objective To examine treatment outcomes among a cohort of patients diagnosed with refractory pelvic and/or genital pain enrolled in a 3-week interdisciplinary pain rehabilitation program (IPRP). Methods A series of with-in subjects ANOVAs (corrected for multiple comparisons) were used to evaluate the effectiveness of IPRP on self-report (pain severity, interference, depressive symptoms, quality of life) and observer-rated outcome (5 minute walk) among 15 treated patients receiving care at the Mayo Clinic IPRP between 2016-2018. Results Fifteen patients (5 male, 10 female) were identified. Mean age was 47.0 (range: 24-78) and primary diagnoses were pelvic pain (n=13) and penile pain (n=2). Significant within-subject effects were detected for all self-report outcomes and the 5-minute walk test (see table 1). Six patients were on opioid therapy (MME = 49mg), and all but one successfully tapered off opioids. In the remaining patient, daily MME decreased from 150 mg to 30 mg. Conclusions Intensive outpatient IPRP significantly improves quality of life for patients with treatment-refractory chronic pelvic and/or genital pain. These results support multi-disciplinary treatment paradigms for refractory urogenital pain. Disclosure No