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.

Subcoronal Incision for Inflatable Penile Prosthesis Does Not Risk Glans Necrosis.

PURPOSE: Glans vascular compromise had previously been considered a rare but devastating complication of the subcoronal incision for inflatable penile prosthesis surgery. Here, we describe the largest series of subcoronal implants to date to assess contemporary complication rates. MATERIALS AND METHODS: A retrospective review of subcoronal prosthesis placements by a single surgeon from Seoul, South Korea, was performed. Patients were randomly assigned either Coloplast Titan or AMS 700 device per institutional practice. RESULTS: A total of 898 patients who underwent subcoronal implants from May 2015 to March 2022 were analyzed. Median follow-up was 41 months (IQR 40). Preoperative patient comorbidities included diabetes (36.6%) and Peyronie's disease (4%). The most common complication was transient distal penile edema (74.7%). Transient incisional paresthesia (20.6%) was more common in patients with diabetes (31.9% vs 13.9%, P < .01). Five cases (0.5%) of distal penile skin necrosis were reported in patients who had previously been circumcised. Of these, 3 were managed successfully with wet-to-dry dressing, 1 required skin grafting, and 1 required device explant. Device infection without incisional compromise occurred in 2 cases (0.2%). There were no instances of glans necrosis or ischemia observed in this cohort. Of the first-time implants (817, 90.9%), most (62.3%) were successfully completed under local anesthetic alone, with the remainder of surgeries completed with the addition of adjunctive conscious sedation. CONCLUSIONS: Subcoronal incision for first-time or revision penile implant surgery is not a risk factor for glans ischemia or necrosis and can be safely completed under local anesthetic with or without conscious sedation.

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.

Is there still a place for malleable penile implants in the United States? Wilson's Workshop #18.

The use of semirigid rod penile prosthesis for the management of erectile dysfunction was first described over 85 years ago. Since then, there have been numerous design advancements leading to improved overall durability, concealability, rigidity, and natural feel. However, the inflatable penile prosthesis (IPP) still has a higher patient satisfaction rate and is currently the most commonly inserted prostheses in the United States. There are still certain situations and conditions where the simplicity of a rod may be preferred over an IPP. A pair of semirigid rods has been shown to have less risk of malfunction and need for revision surgery. In addition, patients with poor manual dexterity, those undergoing a salvage for infection prosthesis and those with a prolonged (> 48 h) priapic episode may be better served with a rod than an IPP. Finally, in patients compromised by infection or priapism, the rods can later successfully be exchanged for an IPP with potentially longer, wider cylinders with resultant greater patient satisfaction.

Evolution of techniques for aesthetic penile enlargement during prosthesis placement: a chronicle of the Egydio non-grafting strategy.

Since penile prostheses only provide axial rigidity, correction of penile deformity and enlargement of the visible penis during implant surgery may be desired. Evolving techniques of tunica expansion have made it possible to avoid grafting and preservation of the cylindrical appearance without bulges and indentations. After two decades of devising individualized solutions for patients and continuous enhancements of existing surgical solutions, Dr. Paulo Egydio has arrived at his Tunica Expansion Procedure (TEP). This strategy is his newest iteration of a lengthening techniques without grafting accompanied by penile prosthesis implantation. The TEP Strategy permits surgeons to use their own intuitive reasoning to determine the best pattern of multiple, small, staggered incisions to promote length and girth enlargement.

Implant practice building: tenets to growing a successful and rewarding practice.

Achieving a thriving sexual medicine practice with a high volume of penile implants is both challenging and rewarding for the prosthetic surgeon. It is not an easy feat to accomplish. Techniques of practice building from physician referrals and marketing to the patient have changed remarkably in the era of social media. Peer-to-peer continues to be a critical source of physician referrals, but methods of "getting the word out" to patients have drastically altered. Internal marketing to one's own patients and external passing of information to prospective clients requires a robust presence on the internet. This workshop will focus on the achievement of high-volume implant practices in the age of the World Wide Web. Despite accomplishing this triumph through use of digital media, it is important to continue personal attainments to maintain your ethical image amongst your physician peers and the general public.

Penile implant infection part 3: the changing spectrum of treatment.

Penile prosthesis infection remains a rare but devastating complication of implantation. Historically, management of device infection was always extirpation. While certainly effective, device removal leaves an unhappy patient with a shortened penis. In this last part of a three-part series on the topic of penile prosthesis infection, we seek to highlight new and emerging ideas of infection management which have allowed surgeons the option of preserving the implanted status in select patients.

Nuances of subcoronal inflatable penile prosthesis for physicians accustomed to penoscrotal approach.

In a special miniseries highlighting the different surgical techniques to the inflatable penile prosthesis (IPP), Wilson's Workshop seeks to bring forth skill considerations for the modern implanter. Each work is authored by a highly regarded surgeon who has truly honed the art of their respective approach. Today, most implanters are comfortable with either the penoscrotal or suprapubic incision. The following work directs the spotlight onto a much newer and less known technique, IPP implant via the subcoronal incision. SHP leads the Urology Center of Excellence in Seoul, South Korea, and has implanted more than 700 IPPs using the subcoronal approach since 2015. Here, he will share the clinical pearls of this novel incision gathered through trial and error over many repetitions. We are hopeful that this work will peak the interest of inquisitive minds and help disseminate improved implant techniques.

The last survivor of unitary and two-piece inflatables-the Ambicor. Does it still have a role in today's implant marketplace?

The history of the development of today's very dependable three-piece inflatable penile prostheses is fascinating. In its infancy, the three piece was plagued with frequent revisions and a relatively complex insertion and consequently unitary and two-piece prostheses flourished with the implanting urologists. While the surgery was less difficult because these devices did not require the dreaded reservoir insertion, they often proved unsatisfactory to patients in flaccidity, erection and longevity. By the turn of this century all of the unitary and two-piece inflatables had been withdrawn from the market except the Ambicor two-piece inflatable penile prosthesis. This paper covers the history of the various unitary and 2-piece inflatable models before examining a critical question: is the Ambicor 2-piece still a needed implant today?

Nuances of infrapubic incision for inflatable penile prosthesis.

This workshop completes the trilogy of nuances of the various incisions used to place an inflatable penile prosthesis (IPP). Infrapubic placement was the original technique employed 50 years ago for the very first IPP surgeries. The historical perspective of the development of implantation incisions and the original Scott prosthesis highlighted in this work should be fascinating to today's younger prosthetic urologists. The developing surgeon should also find some surprising maneuvers considered important technique nuances from the highest volume infrapubic implanter in the world. Among the wonders of the infrapubic approach covered are: The surgery is conducted without the aid of an in-dwelling Foley catheter or post-operative inflation. Hydrodistension of the corpora substitutes for corporal dilatation. The "chicken choke" protects the urethra from damage. Closed suction drainage is employed despite minimal scrotal dissection. Motivated patients may use their new device as early as 14 days after implantation.

The emerging role of somatic tumor sequencing in the treatment of urothelial cancer.

The development of rapid genome sequencing has greatly enhanced our understanding of the molecular biology underlying many malignancies. Whole exome sequencing has highlighted the individualistic nature of malignancies on a patient-to-patient basis and begun to revolutionize therapeutic approaches. In recent years, whole genome sequencing of urothelial malignancies has identified a host of somatic mutations which contribute to growth, progression, and metastasis of urothelial carcinoma of the bladder and upper tract urothelial carcinoma. As genetic sequencing continues, additional targets will be identified, allowing development of novel therapeutic agents targeting cancer on a molecular level, with the goal of delivering highly individualized care based on the underlying mutational profile of the patient's malignancy. In this review, we aim to discuss known genetic alterations of urothelial malignancy and the implications these mutations carry in terms of prognostication and development of targeted therapeutic agents. We will focus on RNA-expression profiling and genomic DNA profiling, with a focus on comprehensive whole exome and whole genome sequencing relative to selected urothelial carcinoma-associated genes and circulating tumor DNA analysis.

A narrative review of the management of benign prostatic hyperplasia in patients undergoing penile prosthesis surgery.

Penile prosthesis surgery is an effective and durable treatment modality for patients who have failed conservative management for erectile dysfunction (ED). Thorough patient counseling and appropriate preoperative workup lay the foundation for a successful outcome. While the risk of infection of penile prosthesis is rare, it is a dreaded complication with dire consequences. The goal of the prosthetic surgeon is to minimize the risk of preventable complications. Given the common prevalence of benign prostatic hyperplasia (BPH) in this patient population, it is essential that providers are familiar with the implications and nuances of managing both conditions in order to maximize the chances of a favorable result. Due to the relatively infrequent nature of complications associated with the management of BPH in the setting of a penile prosthesis, literature regarding this topic is scarce. In this narrative review we present our own case series illustrating some of the most common scenarios that a prosthetic surgeon may encounter. We have included our suggestions for management in these difficult situations based on our clinical experience. In the following review we have highlighted the importance of identifying and treating BPH in penile implant candidates to reduce postoperative morbidity and to offer critical insights into managing BPH-related complications this population.

Penile implant infection prevention part II: device coatings have changed the game.

The single most important factor in the reduction of penile implant infections has been the infection retardant coatings. Virtually every inflatable penile prosthesis (IPP) sold for the last 15 years in America has been coated and the device infection rate has dropped over 50% to less than 1% in experienced implanter practices. The vast majority of penile implants are contaminated with bacteria at time of surgery and the bacteria live within the implant spaces in a quiescent fashion protected by a biofilm secreted by the organisms that makes them impermeable to antibiotics or the body's defense mechanisms. Only very rarely do the bacteria cause a clinical infection. Medicine has no clue why this atypically happens. There are new recommendations for systemic prophylactic antibiotics-a testimonial to the changing face of the bacteria causing device infection. New washout solutions are being utilized and new salvage guidelines are being studied.

Penile implant infection prevention part 1: what is fact and what is fiction? Wilson's Workshop #9.

Inflatable penile prosthesis (IPP) infections are undeniably devastating for patient and surgeon alike. While less common in this modern era, the landscape of prosthesis infection is shifting. Continued examination of risk factors for infection and re-evaluation of common practices remain critical should we aim to advance the field. Quality research on this topic is limited by several factors, among which small sample size and lack of coordinated effort pose the most precarious of challenges. Nonetheless, careful analysis of available data in conjuncture with judicious utilization of established research from other prosthetic fields can help us better grasp the issue at hand. In this review, we aim to do exactly that-to examine available evidence in an effort to discern fact from fiction. In this first part of the three part series, we aim to summarize our understanding of the pathogenesis behind prosthesis infections, explore known preoperative risk factors, and discuss intraoperative considerations for infection prevention. In the second part of this series, we will examine the game changing effect of infection retardant implant coatings. Part three of the series details postoperative prevention strategies, reviews salvage techniques, and discusses additional key considerations.

The androgen receptor regulates a druggable translational regulon in advanced prostate cancer.

The androgen receptor (AR) is a driver of cellular differentiation and prostate cancer development. An extensive body of work has linked these normal and aberrant cellular processes to mRNA transcription; however, the extent to which AR regulates posttranscriptional gene regulation remains unknown. Here, we demonstrate that AR uses the translation machinery to shape the cellular proteome. We show that AR is a negative regulator of protein synthesis and identify an unexpected relationship between AR and the process of translation initiation in vivo. This is mediated through direct transcriptional control of the translation inhibitor 4EBP1. We demonstrate that lowering AR abundance increases the assembly of the eIF4F translation initiation complex, which drives enhanced tumor cell proliferation. Furthermore, we uncover a network of pro-proliferation mRNAs characterized by a guanine-rich cis-regulatory element that is particularly sensitive to eIF4F hyperactivity. Using both genetic and pharmacologic methods, we demonstrate that dissociation of the eIF4F complex reverses the proliferation program, resulting in decreased tumor growth and improved survival in preclinical models. Our findings reveal a druggable nexus that functionally links the processes of mRNA transcription and translation initiation in an emerging class of lethal AR-deficient prostate cancer.

Does the Diagnosis of Bladder Cancer Lead to Higher Rates of Smoking Cessation? Findings from the Medicare Health Outcomes Survey.

PURPOSE: Smoking is the most common risk factor for bladder cancer and it is associated with adverse clinical outcomes. The bladder cancer diagnosis represents a teachable moment for smoking cessation. We investigated the likelihood of smoking cessation after bladder cancer diagnosis in a population database. MATERIALS AND METHODS: We evaluated the 1998 to 2013 SEER (Surveillance, Epidemiology and End Results)-MHOS (Medicare Health Outcomes Survey) data on all patients diagnosed with incident bladder cancer on whom survey data were available before and after diagnosis. We compared these patients to propensity matched noncancer controls and to a cohort of patients with incident renal cell carcinoma. Differences in smoking cessation were compared between the groups and multivariate logistic regression was performed to assess the likelihood of smoking cessation. RESULTS: We propensity matched 394 patients with newly diagnosed bladder cancer to 1,970 noncancer controls and compared them with 169 patients with incident renal cell carcinoma. Baseline smoking prevalence was more common in patients diagnosed with bladder cancer compared to renal cell carcinoma (16% vs 11%) but the difference was not significant. The smoking cessation rate in patients with bladder cancer was 27% compared with 21% in noncancer controls and 26% in patients with renal cell carcinoma (p = 0.30 and 0.90, respectively). There was no significant difference in the adjusted OR of quitting smoking in patients with bladder cancer vs those with renal cell carcinoma compared to noncancer controls (OR 1.3, 95% CI 0.7-2.5 vs OR 1.2, 95% CI 0.4-3.6). Independent predictors of smoking cessation in patients with bladder cancer included age (p = 0.03), African American race (p = 0.03) and college education (p = 0.01). CONCLUSIONS: Compared to propensity matched noncancer controls smoking cessation did not significantly differ after a diagnosis of bladder cancer. The proportion of individuals who quit was low overall, suggesting that improved efforts are needed to use this teachable moment in patients with bladder cancer.

Cell type-specific abundance of 4EBP1 primes prostate cancer sensitivity or resistance to PI3K pathway inhibitors.

Pharmacological inhibitors against the PI3K-AKT-mTOR (phosphatidylinositol 3-kinase-AKT-mammalian target of rapamycin) pathway, a frequently deregulated signaling pathway in cancer, are clinically promising, but the development of drug resistance is a major limitation. We found that 4EBP1, the central inhibitor of cap-dependent translation, was a critical regulator of both prostate cancer initiation and maintenance downstream of mTOR signaling in a genetic mouse model. 4EBP1 abundance was distinctly different between the epithelial cell types of the normal prostate. Of tumor-prone prostate epithelial cell types, luminal epithelial cells exhibited the highest transcript and protein abundance of 4EBP1 and the lowest protein synthesis rates, which mediated resistance to both pharmacologic and genetic inhibition of the PI3K-AKT-mTOR signaling pathway. Decreasing total 4EBP1 abundance reversed resistance in drug-insensitive cells. Increased 4EBP1 abundance was a common feature in prostate cancer patients who had been treated with the PI3K pathway inhibitor BKM120; thus, 4EBP1 may be associated with drug resistance in human tumors. Our findings reveal a molecular program controlling cell type-specific 4EBP1 abundance coupled to the regulation of global protein synthesis rates that renders each epithelial cell type of the prostate uniquely sensitive or resistant to inhibitors of the PI3K-AKT-mTOR signaling pathway.