Society of Urologic Prosthetic Surgeons' Coding and Billing Position Statement on Ancillary/Adjunct Penile Prosthesis Surgical Procedures: Part I.

OBJECTIVE: To create a society position statement on common adjunct penile prosthesis (PP) procedures. While the Medicare Current Procedural Terminology code book lists descriptions of procedures, it is very brief and lacks detail in the small subspecialty of prosthetic urology. At educational/research meetings, wide variation was found in how experts in prosthetic urology code the same procedures, and need for a standardized format in billing common ancillary surgery was voiced. METHODS: A subcommittee within the Society of Urologic Prosthetic Surgeons developed a survey assessing coding options for several procedures commonly adjunct to PP placement, which was distributed in the fall of 2022. The results of the survey were used to develop consensus statements on coding adjunct PP procedures; statements were distributed among society membership and meetings for approval. RESULTS: Thirty members replied to the survey; demographics were obtained as follows: 73% were trained in a fellowship, 50% identified as university/academic practitioners, and 50% in community/private practice; and 63% respondents place more than 50 implants annually. Only 1 of the 30 respondents stated confidence in coding for these ancillary procedures. Specifically, differences in how to code curvature correction procedures were observed throughout the survey results. CONCLUSION: Only 1 in 30 prosthetic urologists expressed confidence in coding and billing of adjunct PP procedures, further confirming the need for a society position statement. Therefore, we generated a consensus society position statement on common surgeries that are adjunct to PP placement.

Initial safety outcomes for the Rigicon Infla10® inflatable penile prosthesis.

OBJECTIVE: To analyse data from patient information forms (PIFs) submitted to the manufacturer of a new three-piece inflatable penile prosthesis (IPP), the Rigicon Infla10®, to summarize early outcomes. METHODS: A retrospective review of PIFs from 319 patients implanted with the IPP between 6 January 2019 and 31 December 2021 was performed to assess device durability and rates of reoperation for infection, mechanical failure or medical reasons. RESULTS: The mean ± sd (range) follow-up was 21.2 ± 11 (5-36) months and the mean ± sd patient age was 58.5 ± 8.7 years. Of the total, 4.4% of devices required removal or revision. Complications included mechanical failure (2.5%) and component migration (0.7%). No infections were observed in this series. One patient (0.4%) required revision for inadequate straightening of Peyronie's disease. Three patients (0.9%) requested device removal because of dissatisfaction. A total of 95.6% of the Rigicon Infla10 devices were free from explant or revision 21 months after the original implant date. Kaplan-Meier analysis showed the rates of cumulative survival of the device at 12, 24, 36 months were 95.6%, 94.7% and 93.7%, respectively. CONCLUSIONS: The vast majority of the early Rigicon Infla10 IPPs implanted prior to January 2022 were included in this retrospective analysis of volunteered PIFs. These early results demonstrate initial durability from reoperation equivalent to that of other contemporary devices.

Penile Implant Instrument Innovations.

PURPOSE OF REVIEW: Numerous innovations have been made since the first inflatable penile prosthesis was introduced in 1973-not just of the implant apparatus itself, but crucially also in the surgical instruments used for prosthetic surgery. Starting with Dr. Furlow's revolutionary inserter tool, advancements were quickly made in dilators, retractors, and cavernotomes. RECENT FINDINGS: More recent innovations have been made in inserter tools, forceps, needle holders, clamps, and disposable instruments. Leading companies Boston Scientific and Coloplast have contributed significantly to the evolution of IPP surgical placement, and companies such as Uramix and Rigicon are developing a wide array of new specialized tools. We aim to summarize the instruments needed for IPP placement, with a focus on describing the variety of instrument innovations since Dr. Brantley Scott designed and placed the first IPP.

Extended Reality-Assisted Surgery as a Surgical Training Tool: Pilot Study Presenting First HoloLens-Assisted Complex Penile Revision Surgery.

BACKGROUND: Extended reality-assisted urologic surgery (XRAS) is a novel technology that superimposes a computer-generated image on the physician's field to integrate common elements of the surgical process in more advanced detail. An extended reality (XR) interface is generated using optical head-mounted display (OHMD) devices. AIM: To present the first case of HoloLens-assisted complex penile revision surgery. METHODS: We describe our pilot study of HoloLens-assisted penile revision surgery and present a thorough review of the literature regarding XRAS technology and innovative OHMD devices. OUTCOMES: The ability of XRAS technology to superimpose a computer-generated image of the patient and integrate common elements of the surgical planning process with long-distance experts. RESULTS: XRAS is a feasible technology for application in complex penile surgical planning processes. CLINICAL TRANSLATION: XRAS and OHMD devices are novel technologies applicable to urological surgical training and planning. STRENGTHS AND LIMITATIONS: Evidence suggests that the potential use of OHMD devices is safe and beneficial for surgeons. We intend to pioneer HoloLens technology in the surgical planning process of a malfunctioning penile implant due to herniation of the cylinder. This novel technology has not been used in prosthetic surgery, and current data about XRAS are limited. CONCLUSION: OHMD devices are effective in the operative setting. Herein, we successfully demonstrated the integration of Microsoft HoloLens 2 into a penile surgical planning process for the first time. Further development and studies for this technology are necessary to better characterize the XRAS as a training and surgical planning tool. Quesada-Olarte J, Carrion RE, Fernandez-Crespo R, et al. Extended Reality-Assisted Surgery as a Surgical Training Tool: Pilot Study Presenting First HoloLens-Assisted Complex Penile Revision Surgery. J Sex Med 2022;19:1580-1586.

Optimizing Outcomes in Penile Implant Surgery.

Since their initial release in the 1970s, modern penile prostheses have been subjected to continuous improvement with respect to both device engineering and surgical technique. Proper implantation begins with appropriate patient selection and counseling; these are essential elements to optimize results and set expectations postoperatively. An evidence-based protocol for the prevention of infections is essential. A pain management protocol should be initiated even before surgery. Strict adherence to recommended intraoperative techniques minimizes the risk complications; when complications occur, a step-by-step process for management improves odds of resolution. Safe techniques to increase the perceived or actual penile length postimplant can markedly improve patient satisfaction. Postoperatively, the surgeon and the patient should follow strict evidence-based instructions to optimize the overall outcomes of penile prosthesis surgery.

Current Status for Semirigid Penile Prosthetic Devices.

PURPOSE OF REVIEW: The goal of this paper was to evaluate the current use of semirigid penile prosthesis (SRPP), surgical techniques for insertion of SRPP, and how to prevent and approach surgical complications. RECENT FINDINGS: SRPP is a valid option for those who are refractory to medical therapy for erectile dysfunction (ED) and even more appropriate for specific subsets of patient populations. It is important for urologists to know which patient population SRPP is preferred for. Several studies have shown good patient outcomes and patient satisfaction with those who underwent SRPP.

"Pumpology": the Realistic Issues Associated with Pump Placement in Prosthetic Surgery.

PURPOSE OF REVIEW: The goal of this paper was to discuss the issues and/or overt complications associated with the 3-piece inflatable penile prosthesis (3-IPP) pump. We also addressed how to resolve such issues with or without surgical intervention. RECENT FINDINGS: Numerous modifications of the 3-IPP pump have been introduced with multiple techniques to place the pump. These are largely dependent on the approach to place the 3-IPP. Pump issues may inevitably occur, and there are numerous special maneuvers that can be performed to resolve pump issues. It is important for urologists to know maneuvers for pump malfunctions to prevent unnecessary surgical procedures and pump revision. Several studies are reviewed regarding pump issues and patient satisfaction; however, a more structured prospective research project is warranted to further evaluate these issues.

Out of place cylinders discovered in the postoperative period.

If the surgeon makes a flawed and unrecognized movement with an instrument during implantation surgery, the cylinder subsequently may migrate into an unexpected position with inflation and thrusting post operatively. The out of position cylinder is now evident to the patient or symptomatic with discomfort. This 5th Wilson's Workshop will describe our recommended surgeries for correction of out of place cylinders and illustrate the simplest, safest and least invasive.

Distortion of the implanted penis: SST and cylinder crossover.

In the previous workshop we described cylinders out of place due to flawed and unrecognized surgical movements piercing tissue planes that months later are subsequently exploited by the cylinders during sexual intercourse. This workshop completes the trilogy of cylinders out of place. The fourth workshop cataloged fixes of cylinders out of place intraoperatively and the fifth workshop showed the current surgical revision operations to address the cylinders once they have migrated. This sixth workshop will address correction of the implanted penis that is distorted by hypermobile glans, incorrectly measured or crossed over cylinders.

"Doc, if it were you, what would you do?": a survey of Men's Health specialists' personal preferences regarding treatment modalities.

Men's Health is a urological subspecialty that is at the forefront of innovation, but little data exist evaluating the attitudes that andrologists have toward the current treatment modalities available for managing Men's Health conditions. A survey of 37 questions asking what providers would choose as treatment for common conditions was distributed online via Survey Monkey to members of the Sexual Medicine Society of North America and European Society for Sexual Medicine. A total of 115 respondents completed the survey after an initial screening question. For erectile dysfunction (ED), 40%, 38%, and 33% of providers indicated that they would use tadalafil daily, tadalafil on demand, or sildenafil on demand, respectively, as first-line phosphodiesterase 5 inhibitor therapy. Furthermore, a total of 74% would elect to undergo low-intensity shockwave therapy [67%], platelet rich plasma injections [15%], and stem cell injections [15%]. Sex/behavioral therapy was preferred for both premature (36%) and delayed (52%) ejaculation. Approximately 44% of respondents indicated that they would undergo Collagenase Clostridium Histolyticum injections for Peyronie's Disease in the acute phase. In the setting of hypogonadal symptoms with borderline low total testosterone levels (300-400 ng/dL), 69% of respondents would pursue testosterone therapy. The prostatic lift procedure was the preferred procedure for men seeking symptom resolution with preservation of ejaculatory function. Many Men's Health specialists would pursue the least invasive options before considering procedural intervention for any given condition. Providers may shift their treatment preferences toward newer treatment modalities as longer term data become available.

High risk of thrombosis in patients with advanced lung cancer harboring rearrangements in ROS1.

INTRODUCTION: Based on the high incidence of thromboembolic events (TEs) observed in lung adenocarcinomas with ALK translocations and taking into account the biological proximity of ROS1 and ALK, we conducted a retrospective analysis of patients with advanced lung carcinoma carrying rearrangements in ROS1 from 23 centres in Spain and one centre in Portugal. METHODS: The main objective of the study was to analyse the incidence of TE in this population, looking for predictive risk factors, and its impact on overall survival. RESULTS: A total of 58 patients were included. The incidence of TEs throughout the disease was 46.6% (n = 27) with a median follow-up of 19 months (range: 1-78 months) and a median overall survival of 52 months in the total population and 50 months for the patients presenting TEs, with a hazards ratio of 1.12 (95% confidence interval: 0.47-2.65) p = 0.78. The majority of the events were venous (n = 24; 89%) and occurred in the ambulatory setting (n = 18; 67%). Almost half of the patients (n = 13; 48%) presented the TE in the peri-diagnostic period. CONCLUSIONS: The high incidence of thrombosis, especially during the cancer diagnosis process, requires special attention from a clinician. Despite the limitations of such a small descriptive study, its results are in accordance with previously reported data. It would be important to design prospective studies of antithrombotic prophylaxis in this population because of their possible impact in reducing the risk of TEs.

Distal Biologic Cap for Impending Distal Erosion.

INTRODUCTION: Management for distal impending erosion can be difficult and has been previously managed with counter incisions which can lead to unsightly scars and increased infection risk. AIM: To demonstrate a novel technique in management of impending erosion. METHODS: We retrospectively reviewed patients who underwent placement of a distal biologic cap for impending erosion. MAIN OUTCOME MEASURE: The main outcome was thesuccessful placement of inflatable penile prosthesis through a single incision. RESULTS: All patients who underwent this procedure are functional and have had no evidence of recurrence. CLINICAL IMPLICATIONS: A simple approach to manage impending distal erosion. STRENGTH & LIMITATIONS: Limitations include small sample size and short duration of follow-up. CONCLUSION: The distal biologic cap is a simple alternative technique to treat distal impending erosion of an inflatable penile prosthesis and can be performed safely without the need for additional incisions on the penis and with a minimal increase in operative times. Karpman E, DiGiorgio L, Carrion RE. Distal Biologic Cap for Impending Distal Erosion. J Sex Med 2020;17:551-555.

Multicenter investigation on the influence of climate in penile prosthesis infection.

The purpose of this study is to investigate the relationship between inflatable penile prosthesis (IPP) infection, time of year, climate, temperature and humidity. This is a retrospective IRB-approved analysis of 211 patients at 25 institutions who underwent salvage procedure or device explant between 2001 and 2016. Patient data were compiled after an extensive review of all aspects of their electronic medical records. Climate data were compiled from monthly norms based on location, as well as specific data regarding temperature, dew point, and humidity from dates of surgery. Rigorous statistical analysis was performed. We found that penile prosthesis infections occurred more commonly in June (n = 24) and less frequently during the winter months (n = 39), with the lowest number occurring in March (n = 11). One-hundred thirty-nine infections occurred at average daily temperatures greater than 55 °F, compared to 72 infections at less than 55 °F. The incidence rate ratio for this trend was 1.93, with a p-value of <0.001. Humidity results were similar, and fungal infections correlate with daily humidity. Infected implants performed in the fall and summer were over 3 and 2.3 times, respectively, more likely to grow Gram-positive bacteria compared to implants performed in spring (p = 0.004; p = 0.039). This was consistent across geographic location, including in the Southern hemisphere. We found trends between climate factors and IPP infection like those seen and proven in other surgical literature. To our knowledge these data represent the first exploration of the relationship between temperature and infection in prosthetic urology.

Simulation Training in Penile Implant Surgery: Assessment of Surgical Confidence and Knowledge With Cadaveric Laboratory Training.

INTRODUCTION: Constraints on surgical resident training (work-hour mandates, shorter training programs, etc.) and availability of expert surgical educators may limit the acquisition of prosthetic surgical skills. As a result, training courses are being conducted to augment the prosthetic surgery learning experience. AIM: To evaluate the impact of a hands-on cadaver-based teaching program on resident procedural knowledge and procedural confidence with placement of a penile prosthesis. MAIN OUTCOME MEASURE: Changes in procedural knowledge and self-confidence following a focused training program on penile prosthetics. METHODS: As part of the 2017 Society of Urologic Prosthetic Surgeons and the Sexual Medicine Society of North America Annual Meeting, 31 urology residents participated in a simulation lab in prosthetic urology. The lab included didactic lectures and a hands-on cadaveric laboratory. Participants completed surveys before and after the course. Wilcoxon Signed Rank tests for matched pairs were used to compare respondents' pre- and postcourse knowledge (% questions answered correctly) and confidence ratings. Prior implant experience was assessed. RESULTS: 31 residents participated in this study. The majority of the participants were 4th- (41.9%) and 5th-year residents (38.7%). Participants showed a significant improvement in procedural knowledge test scores (68.8±13.4 vs 74.2 ± 13.0, P < .05) and self-reported increased median surgical confidence levels (4 vs 3, P value < .001) after completion of the cadaveric course. Subgroup analysis demonstrated that residents with prosthetic surgery experience of <10 cases benefited the most. In addition, improvement in surgical confidence levels observed was greater than the improvement in surgical knowledge. The overall cost of the simulation training course was approximately $1,483 per resident. CONCLUSION: Simulation training in prosthetic surgery seems to improve surgical confidence and knowledge. Further research is needed to better understand the benefits and limitations of simulation training. Lentz AC, Rodríguez D, Davis LG. Simulation training in penile implant surgery: Assessment of surgical confidence and knowledge with cadaveric laboratory training. Sex Med 2018;6:332-338.

Prostatic Urethral Lift: Does Size Matter?

OBJECTIVES: To assess if prostatic urethral lift (PUL) can be as effective on larger prostates. PUL is an endoscopic device that retracts prostatic tissue to relieve benign prostatic hypertrophy (BPH) obstruction. In 2013, PUL was approved for patients with a prostate size of <80 g and no median lobes. The approval was primarily based on the L.I.F.T. study, which only evaluated patients with prostates between 30 and 80 g in size. MATERIALS AND METHODS: Seventy-four patients underwent PUL between April 2, 2014, and December 2, 2015, for BPH management. Fifty-one patients were in the <80 g prostate group (median: 46 g, range: 20-78 g) and 23 in the >80 g prostate group (median: 112 g, range: 81-254 g). Student t-tests and Fisher's exact tests were used to compare continuous and categorical variables. p-Value of <0.05 was considered statistically significant. RESULTS: Median time between PUL and follow-up AUA symptom score (AUASS) was 144 days. A difference between the numbers of PUL implants used was seen. A significant improvement in AUASSs was seen in both groups following the procedure. There was no significant difference in age, AUASS before or after the procedure, or need for an additional outlet procedure between the two groups. CONCLUSION: Early experience finds that a sufficient number of men with larger prostates appear to benefit from PUL. Patients with >80 g prostate size were more likely to have a median lobe and may benefit from resection of the median lobe at time of the PUL. Long-term follow-up is needed to evaluate the durability of the PUL procedure.

Intralesional Injection of Collagenase Clostridium histolyticum May Increase the Risk of Late-Onset Penile Fracture.

INTRODUCTION: The use of intralesional injection of collagenase Clostridium histolyticum (CCH) has become a valid treatment option in the management of Peyronie's disease (PD). Multiple studies have shown the drug's safety and efficacy. However, sparse literature exists on the utility of the injection protocol's 14-day "observation period," in which patients are instructed to abstain from all sexual activity. AIM: To summarize the contemporary literature and report on our series of patients treated with CCH in an effort to explore the effectiveness of the postinjection observation period. METHODS: We retrospectively reviewed the clinical course of men treated with at least one CCH injection at our institution from April 2014 through February 2017. MAIN OUTCOME MEASURES: The main outcome measure for our cohort was complication rate (hematoma, fracture). Secondary outcomes included progression to corrective surgery. RESULTS: Of the 102 patients treated, 5 (4.9%) developed a corporal fracture. Four of these occurred outside the 14-day observation period. One fracture was managed conservatively and the rest underwent surgical exploration and repair. Twelve penile hematomas were reported; one of these patients was surgically explored because of suspicious magnetic resonance imaging findings. Seven patients (6.9%) progressed to corrective surgery. CONCLUSION: Penile hematoma and corporal fracture are serious complications that must be discussed with patients before initiation of intralesional CCH treatment. Little evidence exists to direct physicians on the proper management of post-CCH penile fractures; many caregivers and patients elect to treat these injuries conservatively and avoid surgical exploration. Further studies are warranted to generate discussion and reassessment regarding the safety and effectiveness of this 14-day observation period. Beilan JA, Wallen JJ, Baumgarten AS, Morgan KN, Parker JL, Carrion RE. Intralesional Injection of Collagenase Clostridium histolyticum May Increase the Risk of Late-Onset Penile Fracture. Sex Med Rev 2018;6:272-278.

Penile sparing surgical approaches for primary penile tumors: preserving function and appearance.

Penile cancer is a rare and potentially disfiguring disease. There are multiple treatment options for primary penile lesions. Penile sparing approaches offer an attractive option as they can provide several quality of life benefits without detrimental oncologic outcomes. With appropriate diagnostic evaluation and staging, penile sparing techniques provide proper cancer control with improved cosmetic and functional results. Regardless of the chosen treatment modality, a commitment to close follow-up remains a critical component of all treatment considerations. The goal of this review is to provide an overview of the multiple treatment strategies for primary penile tumors with a focus on penile sparing surgical approaches.

V-Neck Technique: A Novel Improvement to the Infra-Pubic Placement of an Inflatable Penile Implant.

BACKGROUND: Infra-pubic placement of an inflatable penile prosthesis (IPP) has a well-known configuration deformity from contralateral tubing that crosses the corporal bodies, resulting in tubing visibility and irritation under the penile skin. AIM: To present a novel step to eliminate this tubing crossover deformity. METHODS: The V-neck technique was applied to five patients, two of whom underwent suprapubic fat pad excision with simultaneous infra-pubic IPP placement and three patients who underwent only infra-pubic IPP placement. The technique added an additional 1 minute of procedure time. The reservoir was placed on one (ipsilateral) side into the space of Retzius. OUTCOMES: Primary outcome measurements were esthetic appeal at follow-up, immediate postoperative complications, and difficulty of implementation of the technique. RESULTS: The technique included the following steps. (i) The standard infra-pubic approach, as popularized by Perito (J Sex Med 2008;5:27-30), was used to place the reservoir and cylinders. The ipsilateral and contralateral cylinders and the reservoir were clamped and unconnected. (ii) Finger dissection was used to create a sub-phallic window and a U-shaped aortic clamp was used to pass the contralateral tubing. (iii) After passing the green tubing through the window, all connections were performed in the usual fashion. Tubing crossover was eliminated, as was passage of the right and left cylinder tubes down their respective gutters. Postoperative follow-up at 2 weeks showed no visible tubing. CLINICAL IMPLICATIONS: This simple maneuver could help prevent the discomfort of tubing crossover deformity commonly seen after infra-pubic placement of an IPP. STRENGTHS AND LIMITATIONS: This unique maneuver can be applied to all infra-pubically placed IPPs. Limitations include the small patient population and short follow-up. Whether this maneuver will make revision surgery more difficult is unclear. CONCLUSION: This technique is a novel step to infra-pubic IPP placement that adds minimal operative time and could eliminate visible tubing. Shah BB, Baumgarten AS, Morgan K, et al. V-Neck Technique: A Novel Improvement to the Infra-Pubic Placement of an Inflatable Penile Implant. J Sex Med 2017;14:870-875.