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.
(545) Frankenstein & Beyond: IPP Fixes with Pump Exchange and Fluid Addition
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
(454) Variations in Practice Patterns of Xiaflex Providers Throughout the United States
Abstract Introduction Intralesional Collagenase Clostridium Histolyticum (CCH; Xiaflex; Endo Pharmaceuticals, Dublin, Ireland) is the only FDA-approved intralesional therapy to treat bothersome penile curvature in men with Peyronie’s Disease (PD). Clinicians who administer CCH must be certified through a risk evaluation and management strategy (REMS) program. However, provider availability is highly dependent on geography and many patients must travel great distances to undergo evaluation and treatment with CCH by an experienced injector. Objective The goal of the current study is to describe the landscape of certified CCH injectors with respect to location and clinical background/training. Methods Patients are currently able to use an online “locate a specialist” tool through Endo Pharmaceuticals to identify clinicians in their local geographic area who are certified to administer CCH. Using this tool, a list of all providers who offer CCH injections was compiled throughout the continental United States. Pertinent information that was gathered included geographic location, type of provider or level of training [Medical Doctor (MD), Doctor of Osteopathic Medicine (DO), Physician Assistant (PA), Nurse Practitioner (NP), and Registered Nurse (RN)], and gender of providers. This information was compared to state population data (United State Census Bureau) to determine per capita coverage. Results A total of 1947 Xiaflex providers were identified: 1749 Doctors of Medicine (MD; 90%), 115 Doctor of Osteopathic Medicine (DO; 6%), 60 Physician Assistants (PA; 3%), 21 Nurse Practitioners (NP; 1%), and 1 Registered Nurse (RN; 0.05%). Out of the 1947 providers, only 95 (4.9%) were women. Most women administering Xiaflex were MDs (73%), followed by PAs (12%), NP and DOs (7%), and RN (1%). Xiaflex providers were available in all states except for Hawaii and Alaska. Providers were distributed throughout the United States with the average provider per capita ratio of 230,240. Wyoming, Washington D.C., Rhode Island, and Georgia had the best provider per capita at <10,000 while New Mexico had the worst provider per capita ratio at 2,117,522. Conclusions Our results show significant variation in certified CCH injector availability for patients across the United States. < 5% of all certified clinicians are female and 4% were advanced practice providers. Further work is needed to characterize and remedy gender disparities amongst providers, and ensure greater access for patients who desire an FDA-approved non-surgical treatment for their PD-associated curvature. Disclosure No
093 Online Marketing Practices of Vasectomy Reversal Providers in the United States
ABSTRACT Introduction Vasectomy reversal (VR) is rarely covered by insurance, creating a market similar to cosmetic surgery with direct marketing to patients. While cost is an immediate concern for patients, surgeon training and experience are essential for a successful outcome. Patients considering VR are likely to seek information online regarding providers and the nature of the procedure. Objective In this study, we reviewed the characteristics of providers marketing VR online, as well as the comprehensiveness of their website content. Additionally, we sought to determine differences in VR practice patterns between academic and private practices. Methods We identified VR practices operating within the top 50 populous metropolitan areas in the USA. Practice websites were reviewed to obtain information such as educational background of providers, use of operating microscope, ability to perform vasoepididymostomy (VE), surgical volume, and out-of-pocket cost. Based on the information available from practice websites, providers were assigned a non-validated “REVERSAL score” out of 12, based on 8 domains (Risks disclosure; provider's Educational background; ability to perform VE; Expense disclosure; success Rate disclosure; Surgical volume disclosure; disclosure of Alternatives to VR; and Level of magnification used for VR) (Table). Descriptive statistics were used to compare the results between academic and private practices. Results 107 providers were identified (29 academic and 78 private). All but 2 were male, and similarly all but 2 had Doctor of Medicine (M.D.) degree. Review of practice websites allowed us to obtain complete information (REVERSAL score of 12) on only one provider (academic), with the majority (66%) of providers achieving REVERSAL score of ≤6. Providers with formal fellowship training in andrology, microsurgery, and/or infertility achieved higher REVERSAL scores compared to those without (6.9 ± 2.4 vs. 4.8 ± 2.4, p < 0.01). Academic providers were more likely to have completed pertinent fellowship training compared to private practice providers (97% vs. 44%, p < 0.05). Only 14% of academic providers disclosed procedure cost online, compared to 40% of private practice providers (p < 0.05). There was a trend toward increased use of online advertisements by private practice providers (22% vs. 10%, p = 0.07), and increased reference to literature success rates by academic providers (59% vs. 41%, p = 0.10). Among the 35 providers who disclosed pricing online, mean cost of VR was $5,990 ± 1,935. There was a non-significant trend toward increased cost with academic practices compared to private practices ($7,337 ± 1,103 vs. $5,765 ± 1,964, p = 0.09). There was significant reduction in cost when comparing non-urologists vs. urologists ($3,584 ± 1,554 vs. $6,591 ± 1,518, p < 0.01), and when comparing providers without pertinent fellowship training to those with ($5,405 ± 2,000 vs. $6,769 ± 1,590, p < 0.05). Conclusions There is significant lack of transparency in publicly available information from VR practices, both academic and private. Practices should implement measures to improve the dissemination of information to the general public, so that patients may more easily compare various providers. Disclosure Work supported by industry: no. A consultant, employee (part time or full time) or shareholder is among the authors (Coloplast, AMS).