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.

Penile fibrosis-still scarring urologists today: a narrative review.

Background and Objective: Implantation of penile prosthesis (PP) into scarred and fibrotic corpora can be a difficult challenge. In this review article, we provide a review of penile fibrosis, discuss current medical and surgical management and summarize preventative strategies. Methods: In this study, we searched PubMed between the years 2000-2023 for publications with search strategy: "penile fibrosis" OR "scarred corpora" OR "fibrosed corpora". Key Content and Findings: This search returned a total of 137 articles. We examine the evidence for preoperative patient evaluation and penile ultrasound (US), oral phosphodiesterase-5 inhibitors, pentoxifylline, and L-arginine, vacuum device therapy and the use of surgical approaches and tools in the context of complex penile fibrosis cases. Severe penile fibrosis is most associated with priapism and infection. Estimating the degree of fibrosis via preoperative US may help set realistic patient expectations. Phosphodiesterase inhibitors and L-arginine reduce fibrosis in animal models however their impact in humans remains unclear despite theoretical advantage for their use. Vacuum device therapy may preserve penile length following priapism and infected PP cases. The use of Coloplast Narrow-Based or AMS-700 CXR implants are used primarily for severe fibrosis. Various surgical excisional/incisional techniques, the Carrion-Rossello, Mooreville Uramix cavernotomes and reverse cutting scissors are all options, and their use varies from case to case. Finally, prevention of penile fibrosis in patients with history of penile implant infection and the safety of early implantation of a penile implant in patients with refractory priapism is encouraged. Conclusions: The management of penile fibrosis remains a challenge but there are multiple options to assist clinicians. Complex cases should be managed and studied at high volume centers.

Safety outcomes of the first Rigi10™ malleable penile prostheses implanted worldwide.

Implantation of penile prosthesis is considered when conservative measures fail or are unacceptable to patients' wishing treatment for erectile dysfunction. In the United States (US), inflatable penile prostheses are more often used than malleable penile prostheses (MPP). Outside the US, the reverse is true because third-party reimbursement is not available, and MPP is considerably cheaper. Two American manufacturers make MPP; presently, a new manufacturer, Rigicon (Ronkonkoma NY), has recently begun to sell its MPP worldwide. Patient information forms submitted to the manufacturer between March 1, 2019, and December 8, 2022, were used to conduct an initial safety study for 605 first-time patients implanted with Rigicon10® by 46 physicians in 15 countries with a mean follow-up of 21.6 months. It has the same configuration of trimmable, paired silicone rods containing a twisted stainless-steel wire for bendability. However, it is available in six widths with hydrophilic coating compared to three widths offered by competitors. Revision or explantation was needed in 6 of 605 patients (0.99%) with half of those being removed for dissatisfaction (0.50%). Two (0.33%) suffered device infection and one (0.16%) required removal for erosion. Kaplan-Meier's statistical analysis showed three-year implant survival from revision = 99.2%. It demonstrated a comparable safety record with less than 1.00% of patients requiring reoperation.

Patient selection, counseling and preparation for penile prosthesis.

The penile prosthesis has revolutionized the management of erectile dysfunction and is a mainstay in the treatment of this clinical entity. The goal of proper patient selection and counseling is to achieve a satisfactory outcome for the patient. Most patients receiving a penile prosthesis are satisfied with their outcome, and while the penile prosthesis generally allows for high satisfaction rates, avenues for dissatisfaction can arise. Our aim is to aid the prosthetic urologist in identifying such avenues by discussing what factors can lead to a dissatisfied patient. Even a technically successful surgical outcome in the improperly counseled patient can have negative consequences for the patient and the patient-physician relationship. Satisfaction in the penile prosthesis arena can be variably defined and viewed from different perspectives. As such, establishing a personalized framework of expectation management, even in the patient who poses challenging factors, is paramount in preparation for penile prosthesis implantation.

Three piece penile prosthesis salvage with chlorhexidine gluconate and length preservation: our technique and outcomes.

OBJECTIVE: Since the advent of the Mulcahy technique of three-piece inflatable penile prosthesis (IPP) salvage, there have been multiple iterations of salvage prosthesis procedures reported in the literature. All of these techniques employ traditional antibiotic irrigation with or without rechanneling. We present our technique of salvage IPP using 0.05% chlorhexidine gluconate (Irrisept®) with corporal rechanneling for length preservation. MATERIALS AND METHODS: Our technique of IPP salvage begins with access via a 5 cm vertical midline scrotal incision. Dissection down to the corpora is performed with a combination of blunt dissection and dissection with fine tipped Metzenbaum scissors. Each component of the prior IPP is sequentially removed starting with the cylinders, followed by the pump, and finally the reservoir. Irrisept® is used to copiously irrigate out both cavernosal bodies as well as the scrotal compartment and prior reservoir location. A two minute dwell time of the Irrisept® is employed after mechanical irrigation. A penrose drain is placed from the space of Retzius through a separate stab incision in the scrotum. Corporotomies are closed, followed by Dartos fascia and scrotal skin. A complete change in gown and gloves of all members of the surgical team and a new set of drapes and instruments is performed. Through a separate subcoronal incision, two new corporotomies are made and separate channels created using nine inch Metzenbaum scissors. These channels are irrigated with Irrisept®. A 9 mm malleable penile prosthesis (MPP) is inserted and corporotomies and skin incision are closed. RESULTS: A total of four men with prior penoscrotal IPP placement underwent salvage IPP with MPP from January 2022 to October 2022. Median operative time was 165 minutes. Median preoperative cylinder size was 23.5 cm. Median postoperative malleable cylinder size was 23 cm. Median length of follow up was 4.8 months. There were no cases of MPP erosion or infection. Two patients elected to undergo repeat IPP insertion after 6 months with same cylinder size. CONCLUSION: IPP salvage with chlorhexidine irrigation and soak as well as separate corporal channeling in a noninfected field for MPP insertion is a viable strategy for infected prostheses given the ease of performance, low risk of repeat infection of the malleable device, and maintenance of corporal length of any subsequent prostheses.

Circumcision and Sexual Medicine.

INTRODUCTION: Male circumcision is one of the most frequently performed and debated urological procedures due to its possible implications for sexual health. OBJECTIVES: The objective of this article is to review the literature on male circumcision and reconcile the scientific evidence to improve the quality of care, patient education, and clinician decision-making regarding the effects on sexual function of this procedure. METHODS: A review of the published literature regarding male circumcision was performed on PubMed. The criteria for selecting resources prioritized systematic reviews and cohort studies pertinent to sexual dysfunction, with a preference for recent publications. RESULTS: Despite the conflicting data reported in articles, the weight of the scientific evidence suggests there is not sufficient data to establish a direct association between male circumcision and sexual dysfunction. CONCLUSION: This review provides clinicians with an updated summary of the best available evidence on male circumcision and sexual dysfunction for evidenced-based quality of care and patient education.

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.

Infection of the Penuma penile implant and associated post-operative complications: A case report.

The Penuma penile implant is the only FDA approved device for cosmetic correction of the penis. We present a case of an infected Penuma implant that presented similarly to penile prosthesis infection. Explantation is recommended, similar to the management of infected penile prosthesis, via an infrapubic approach, which differs from explantation of a penile prosthesis. Post-operatively, the patient developed penile shortening and dorsolateral curve, which is important to discuss when counseling patients.

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.

"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.

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.

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.

Inflatable penile prosthesis cylinders out of place during implantation.

It is safe to say that the overwhelming majority of cylinders out of place result from surgeon error at the time of implantation. There are some instances where patient comorbidities could increase the difficulty of accurate development of cylinder insertion or space. Most of the time the operator recognizes his instrument out of place and corrects it intraoperatively. Other times the surgeon makes a flawed movement with a sharp instrument piercing some tissue. When the cylinder is placed initially and inflated the wayward position is usually not evident. However, in the postoperative period, the inaccurate position of the cylinder(s) can become readily apparent. The reader will notice this repeatedly stressed in Wilson's Workshop-over 90% of cylinders that are out of position can be diagnosed or prevented if one utilizes the two safety checks outlined below.