Inflatable penile prosthesis reservoir placement—Are we ready for a paradigm change? / Colocación de reservorio para prótesis de pene inflables: ¿estamos preparados para un cambio de paradigma?

In 2002, Steve Wilson pioneered new procedures for alternative placement of reservoirs for inflatable prostheses in patients who have suffered damage to the space of Retzius following pelvic surgery or obliteration of the transversalis fascia by mesh hernia repair. Since then, surgical techniques and tools for ectopic reservoir placement have gradually gained acceptance to minimize palpability, and the risk of visceral and vascular lesions for high risk patients has been all but eliminated. Lockout valves and high submuscular placement techniques are now recommended, and reports of vascular, bowel or bladder injuries are uncommonly rare. While surgeons continue their search for safer and more effective placement methods, new skills and instruments are constantly being introduced to make recommendations to minimize complications and provide safety and functionality. Additional studies and comparisons of techniques are needed to achieve a consensus of best practice for reservoir placement solutions. (AU)

En 2002, Steve Wilson fue el precursor de nuevos procedimientos para la colocación alternativa de reservorios para prótesis inflables en los pacientes que habían sufrido daños en el espacio de Retzius tras cirugía pélvica u obliteración de la fascia transversalis por reparación de hernia con malla. Desde entonces, han ido ganando aceptación las técnicas y herramientas quirúrgicas para colocación de reservorio ectópico, a fin de minimizar la palpabilidad, habiéndose eliminado prácticamente el riesgo de lesiones viscerales y vasculares para pacientes de alto riesgo. Hoy en día se recomiendan las válvulas de bloqueo y las técnicas de colocación submuscular alta, siendo excepcionalmente raros los informes sobre lesiones a nivel vascular, intestinal o en la vejiga. A pesar de que los cirujanos siguen investigando en busca de métodos de colocación más seguros y efectivos, se están introduciendo constantemente nuevas competencias e instrumentos en aras de realizar recomendaciones para minimizar las complicaciones y aportar seguridad y funcionalidad. Son necesarios más estudios y comparaciones sobre técnicas para lograr un consenso acerca de la mejor práctica sobre soluciones de colocación de reservorios. (AU)

State of the Reservoir: Current Concepts of Penile Implant Reservoir Placement and Potential Complications.

PURPOSE OF REVIEW: To discuss mechanical and surgical innovations in inflatable penile prosthesis (IPP) surgery and their implications on reservoir placement and patient outcomes. RECENT FINDINGS: The past decade has seen a new emphasis on optimizing outcomes and minimizing complications associated with IPP reservoirs. Innovations in device design have accordingly yielded safer, more durable IPP outcomes over the past four decades. Modifications in surgical approach for reservoir placement abound for both traditional space of Retzius and ectopic reservoir placement techniques. Surgical and medical history, patient anatomy, and patient preference should all be considered when choosing approach for IPP reservoir placement. Prosthetic urologists should be proficient in multiple approaches to provide the best care to their patients.

Penoscrotal approach for IPP: still up-to-date after more than 40 years?

Inflatable penile prosthesis is the definitive operative intervention utilized for treatment of erectile dysfunction. There are a handful of surgical approaches to perform this operation in a safe and efficient manner. The aim of this review article is to discuss the surgical approaches described in the literature, and describe the preferred approach of authors. Ultimately, the surgical approach utilized by the prosthetic surgeon depends upon their training, patient factors, and surgeon preference.

Future considerations in prosthetic urology.

Since their popularization, genitourinary prosthetics have remained a gold-standard therapy for the treatment of erectile dysfunction and stress urinary incontinence and in cases of testicular loss or dysfunction. They have also represented an area of significant innovation, which has contributed to excellent long-term outcomes. Given this history, the objective of the current review was to provide a 5-10-year outlook on anticipated trends and developments in the field of genitourinary prosthetics. To accomplish this objective, a PubMed and patent search was performed of topics relating to penile and testicular prostheses and urinary sphincters. In regard to penile prostheses, findings demonstrated several new concepts including temperature-sensitive alloys, automated pumps, devices designed specifically for neophalluses, and improved malleable designs. With artificial urinary sphincters, new concepts include the ability to add or remove fluid from an existing system, two-piece systems, and new mechanisms to occlude the urethra. For testicular prosthetics, future implementations may not only better replicate the feel of a biological testicle but also add endocrinological functions. Beyond device innovation, the future of prosthetics is also one of expanding geographic boundaries, which necessitates variable cost modeling and regulatory considerations. Surgical trends are also changing, with a greater emphasis on nonnarcotic, postoperative pain control, outpatient surgeries, and adjunctive techniques to lengthen the penis and address concomitant stress incontinence, among others. Concomitant with device and surgical changes, future considerations also include a greater need for education and training, particularly given the rapid expansion of sexual medicine into developing nations.

Future considerations in prosthetic urology / 亚洲男科学杂志(英文版)

Since their popularization, genitourinary prosthetics have remained a gold-standard therapy for the treatment of erectile dysfunction and stress urinary incontinence and in cases of testicular loss or dysfunction. They have also represented an area of significant innovation, which has contributed to excellent long-term outcomes. Given this history, the objective of the current review was to provide a 5-10-year outlook on anticipated trends and developments in the field of genitourinary prosthetics. To accomplish this objective, a PubMed and patent search was performed of topics relating to penile and testicular prostheses and urinary sphincters. In regard to penile prostheses, findings demonstrated several new concepts including temperature-sensitive alloys, automated pumps, devices designed specifically for neophalluses, and improved malleable designs. With artificial urinary sphincters, new concepts include the ability to add or remove fluid from an existing system, two-piece systems, and new mechanisms to occlude the urethra. For testicular prosthetics, future implementations may not only better replicate the feel of a biological testicle but also add endocrinological functions. Beyond device innovation, the future of prosthetics is also one of expanding geographic boundaries, which necessitates variable cost modeling and regulatory considerations. Surgical trends are also changing, with a greater emphasis on nonnarcotic, postoperative pain control, outpatient surgeries, and adjunctive techniques to lengthen the penis and address concomitant stress incontinence, among others. Concomitant with device and surgical changes, future considerations also include a greater need for education and training, particularly given the rapid expansion of sexual medicine into developing nations.

Penile Prosthesis Surgery: Current Recommendations From the International Consultation on Sexual Medicine.

INTRODUCTION: Penile prosthesis implantation has emerged as a definitive treatment to restore sexual function to the motivated man with erectile dysfunction. Substantial improvements in the design of inflatable devices have been made since they first became available more than four decades ago. AIM: To review the history of the penile prosthesis, the indications, preoperative evaluation, and patient and partner satisfaction. The current approaches to addressing intra- and postoperative complications, provide an understanding of prosthesis infection, and placement of these devices will be reviewed. METHODS: A committee of worldwide experts in this field was assembled during the 2015 International Consultation on Sexual Medicine (ICSM) and performed a systematic review of the peer-reviewed published medical literature pertaining to penile prosthesis. Particular attention was given to higher level trials when available. Recommendations are based upon the Oxford Criteria. MAIN OUTCOME MEASURES: Unfortunately there is limited level 1 and 2 evidence, and where expert opinion was utilized, the decision was unanimous within the committee with a goal of presenting a clinically relevant guideline pertaining to penile prostheses. RESULTS: Penile prosthesis has undergone an evolution over the past 40 years resulting in a more effective and reliable treatment for advanced erectile dysfunction not responding to less invasive methods including oral treatment with PDE5 inhibitors, vacuum erection device, and intracorporal injection therapy. It should be considered an appropriate treatment option for the man who wishes to restore erectile function and who understands the potential risk of mechanical failure and infection, both of which are less common now as a result of improvements made in device design as well as surgical protocols adhered to in the operating room. Patients must be clearly informed of the risks associated with penile prosthesis including mechanical failure, infection, shortening of the penis, change in sensation and configuration of the penis, as well as injury to local structures. Intraoperative complications are unusual but do occur and can usually be addressed intraoperatively to allow placement of the device at the time of initial surgery. Postoperative complications may also be addressed when they occur but may require more advanced reconstructive surgical techniques. Men with Peyronie's disease, corporal fibrosis due to infection, trauma, prior prosthesis explantation, priapism, and men who have undergone construction of a neophallus may require additional advanced maneuvers to obtain optimum results with a penile prosthesis. CONCLUSION: Penile prosthesis remains as an important, viable, and effective treatment for male erectile dysfunction that does not respond to other less invasive approaches or when these approaches are contraindicated or not acceptable to the patient. These devices provide the patient with the ability to engage in penetrative sexual activity without interfering with urination, ejaculation, sensation, or orgasm. Although mechanical failure can occur, the current devices are more reliable as a result of design modifications. Infection remains the most dreaded complication but since the introduction of antibiotic and hydrophilic coatings, infection is less common. Overall, patient and partner satisfaction appear to be reasonably high when a penile prosthesis is used to restore erectile function.

Technological Improvements in Three-Piece Inflatable Penile Prosthesis Design over the Past 40 Years.

INTRODUCTION: The advent of the penile prosthesis revolutionized the treatment of erectile dysfunction (ED), resulting in near-complete treatment efficacy and high patient satisfaction rates. While several types of penile prosthesis are available, the inflatable penile prosthesis (IPP) is the most commonly used device in the United States. AIMS: To describe the key modifications to IPPs from the two major manufacturers-American Medical Systems (AMS) and Coloplast-since the invention of the IPP, and to relate these changes to improvements in prosthesis function and patient outcomes based on available literature. METHODS: Review and evaluation of the literature between 1973 and present describing modifications in IPP design and the influence of these modifications on IPP durability and patient-related factors. MAIN OUTCOME MEASURES: Data describing the impact of iterative improvements in three-piece IPP design on device function, durability, and patient outcomes. RESULTS: There were progressive improvements in IPP technology from both major manufacturers not only on the durability of the prosthesis but also on patient outcomes, with fewer device failures and lower infection rates. Notable improvements include incorporation of kink-resistant tubing, changes in the weave or addition of shear- and infection-resistant coatings to cylinder layers, pump and tubing connection modifications, the addition of rear tip extenders, and the incorporation of lockout valves to prevent autoinflation. CONCLUSIONS: Numerous incremental modifications to the IPP from both major manufacturers since its invention have increased its durability and improved patient outcomes.

The Evolution and Utility of the Small-Carrion Prosthesis, Its Impact, and Progression to the Modern-Day Malleable Penile Prosthesis.

INTRODUCTION: Erectile dysfunction has plagued humanity for millennia. For years, treatment had been in the hands of mental health professionals. It was not until the 1970s that urologists created a modality that was marketable, reproducible, and consistently successful at treating impotence, the Small-Carrion Penile Prosthesis. AIM: We present the evolution of the malleable/semi-rigid penile prosthesis, concentrating our efforts reviewing and critiquing the pivotal article published by Drs. Michael P. Small, Hernan M. Carrion, and Julian A. Gordon. We then discuss its continued advancement, current-day utilization, and the future of the malleable prosthesis. METHODS: From the early 1900s, surgeons have been toying with the idea of creating a penile implant. These initial attempts utilized rib cartilage, and eventually synthetic materials, including acrylic, silicone, and polyethylene. RESULTS: In 1975, Drs. Carrion and Small presented their initial experience of 31 patients utilizing their silicone implant. In their manuscript titled, "The Small-Carrion Penile Prosthesis: New Implant for the Management of Impotence," they discuss their technique, perioperative management of complications, and results. CONCLUSIONS: The malleable penile prosthesis continued to evolve throughout the years to the current day Genesis and Spectra. Although the current market is dominated by the inflatable penile prosthesis, there are specific situations where the malleable is ideally utilized. The pivotal article by Drs. Carrion and Small helped pave the way for the "New Era" of penile prosthetics and still remains one of the most impactful contributions to the management of erectile dysfunction.

Evolution of penile prosthetic devices.

Penile implant usage dates to the 16th century yet penile implants to treat erectile dysfunction did not occur until nearly four centuries later. The modern era of penile implants has progressed rapidly over the past 50 years as physicians' knowledge of effective materials for penile prostheses and surgical techniques has improved. Herein, we describe the history of penile prosthetics and the constant quest to improve the technology. Elements of the design from the first inflatable penile prosthesis by Scott and colleagues and the Small-Carrion malleable penile prosthesis are still found in present iterations of these devices. While there have been significant improvements in penile prosthesis design, the promise of an ideal prosthetic device remains elusive. As other erectile dysfunction therapies emerge, penile prostheses will have to continue to demonstrate a competitive advantage. A particular strength of penile prostheses is their efficacy regardless of etiology, thus allowing treatment of even the most refractory cases.

Evolution of penile prosthetic devices

Penile implant usage dates to the 16th century yet penile implants to treat erectile dysfunction did not occur until nearly four centuries later. The modern era of penile implants has progressed rapidly over the past 50 years as physicians' knowledge of effective materials for penile prostheses and surgical techniques has improved. Herein, we describe the history of penile prosthetics and the constant quest to improve the technology. Elements of the design from the first inflatable penile prosthesis by Scott and colleagues and the Small-Carrion malleable penile prosthesis are still found in present iterations of these devices. While there have been significant improvements in penile prosthesis design, the promise of an ideal prosthetic device remains elusive. As other erectile dysfunction therapies emerge, penile prostheses will have to continue to demonstrate a competitive advantage. A particular strength of penile prostheses is their efficacy regardless of etiology, thus allowing treatment of even the most refractory cases.

The evolution of the inflatable penile prosthetic device and surgical innovations with anatomical considerations.

Historically, early surgical treatment for erectile dysfunction involved the placement of rigid devices outside of the corpora cavernosa. This practice resulted in high rates of erosion and infection. Today, most urologists in the United States place an inflatable penile prosthesis (IPP) with an infection-retardant coating inside the corpora cavernosa. In addition to changes in the type of implant used, surgical techniques have evolved greatly in recent years, resulting in reduced operating times, lower infection rates, and improved outcomes. However, anatomical considerations have directed the prosthetic surgeon to improve patient outcomes and satisfaction rates by employing both new surgical techniques and postoperative maneuvers.

Have phosphodiesterase-5 inhibitors changed the indications for penile implants?

OBJECTIVE To evaluate the indications for penile prosthesis implantation in the treatment of erectile dysfunction (ED) before and after the introduction of sildenafil. PATIENTS AND METHODS Penile prosthesis implantation was indicated in 144 men with ED at our institution between 1992 and 2007; 83 (55.6%) accepted the procedure, 55 (38.2%) refused it and six (4.2%) accepted but eventually had no surgery. Sixty-seven patients were operated primarily, and the remainder were referred cases with complications after or dissatisfaction with primary operations done elsewhere. Thirty-two were operated before the introduction of sildenafil (BS) and 35 after (AS). RESULTS In the BS group the most frequent aetiology was vascular disease, with 11(34%) vs two (6%) in the AS group. The most frequent aetiology in the AS group was previous radical pelvic surgery (radical prostatectomy, sigmoidectomy, etc.) with 17 (49%) vs none in the BS group. There were no significant differences in complication rates in both groups. Satisfaction rates in patients with malleable and inflatable devices were 36 (86%) and 17 (85%), respectively. CONCLUSIONS After the introduction of oral therapy for ED there were some changes in the aetiology of refractory ED; ED after radical prostatectomy is gaining acceptance as the main reason for a penile implant.

What is new for inflatable penile prostheses?

PURPOSE OF REVIEW: Although the first inflatable penile prosthesis was introduced over 30 years ago for the treatment of erectile dysfunction, technological innovations have continually improved these penile implants since that time. This review will highlight outcomes reported in peer-reviewed literature during the past 5 years related to several recent advancements in three-piece inflatable penile prosthesis technology of interest to surgeons who implant these devices. RECENT FINDINGS: Research findings reported during the past 5 years have been related to improvements in cylinder and pump design to provide more reliable performance with good device concealment and a normal look and feel, to ease inflation and deflation, and to reduce infection complications with inflatable prostheses. SUMMARY: It is important for all physicians, who implant life-changing penile prosthetics, to understand the most recent advances in technology in order to best serve their patients.

Inflatable penile prostheses for the treatment of erectile dysfunction: an update.

Male erectile dysfunction (ED) is a common medical condition. Three oral medications (sildenafil, vardenafil and tadalafil, all phosphodiesterase type 5 inhibitors) have been developed and approved for the treatment of ED by the US FDA. Extensive worldwide marketing of these medications has raised public awareness of ED, and allowed many previously untreated men to seek and receive effective therapy. A variety of other ED treatments are available and approved by the FDA, including vacuum-constriction devices and intracavernous or intraurethral alprostadil. However, roughly 30-40% of men with ED are not adequately served by these treatments due to their cost, side effects, contraindications, the need to 'time' sexual activity, or lack of satisfactory erectile response. For men who do not respond to less invasive therapy, an inflatable penile prosthesis can provide a satisfying and effective alternative. This article will review and critique the inflatable penile prostheses that are currently available in the USA and the EU for the treatment of ED.

Tratamiento de la disfunción eréctil mediante el implante de prótesis de pene. Análisis de nuestra serie / Treatment of erectile dysfunction with penile prothesis. Our experience

INTRODUCCIÓN Y OBJETIVOS: El objetivo de este estudio fue revisar la situación actual de las prótesis de pene en el tratamiento de la disfunción eréctil; así como analizar las indicaciones, el grado de aceptabilidad y las complicaciones en nuestra experiencia. MATERIAL Y MÉTODOS: Entre 1984 y 2003 implantamos 48 prótesis de pene en varones con edad media de 55 años. Los antecedentes patológicos más frecuentes fueron: enfermedad vascular, diabetes mellitus y cirugía pélvica. El tipo de prótesis utilizada fue inactiva maleable en 7 casos (14,58%), Jonas6, Acu-form1. Activa inflable o hidráulica de 3 componentes en 19 casos (39,58%), AMS 700 plus17, Alpha2. Activa inflable, integrada o autocontenida en 5 casos (10,41%), Hydroflex4, Dynaflex1. Activa inflable de 2 piezas en 17 casos (35,4%), Ambicor2, Mark II15. RESULTADOS: El 6,25% presentó infección protésica que obligó a retirar el implante, y el 4,16% complicaciones mecánicas. El 80% de los pacientes se mostraron satisfechos con la prótesis. CONCLUSIONES: Las prótesis peneanas continúan siendo una alternativa válida y eficaz en el tratamiento del varón con disfunción eréctil, presentando un bajo índice de complicaciones

INTRODUCTION AND OBJETIVES: The aim of this study was to review the current situation of penile prosthesis in the treatment of erectile dysfunction and to analyze the indications, degree of acceptability and complications in oir experience. MATERIAL AND METHODS: From 1984 to 2003, 48 implants were inserted in men suffering from impotence due to different etiologies. The mean age was 55 years. Vascular disease, Diabetes and pelvic surgery were the most common pathologies recorded. The type of prothesis inserted were malleable inactive in 7 cases (14.58%), Jonas6, Acu-form1. Inflable active with 3 components in 19 cases (39.58%), AMS 700 plus17, Alpha2. Inflable active integrated in 5 cases (10.41%) Hydroflex4, Dynaflex1. Inflable active with 2 components in 17 cases (35.4%), Ambicor2, Mark II15. RESULTS: Infection of the prosthesis was observed in 6.25% of the cases. This infectious complication required removal of the prosthesis. 4.16% of the cases complained of mechanical failure that required change of the prosthesis. 80% of the patients were satisfied with the results. CONCLUSIONS: Penile prostheses continue to be an effective and valid therapeutic alternative in impotent. Although the complication rate is low, adequate information must be provided to the patient

ÚItimos avances en la cirugía implante del peneano / Recent developments in penile implant surgery

A pesar de los múltiples tratamientos disponibles hoy para la disfunción eréctil , la prótesis peneana inflable multicompuesta de 3 piezas ha sobrevivido la prueba del tiempo, llegando a ser la modalidad con mayor tasa de éxito y de satisfacción por parte del paciente, debido tanto a la fiabilidad y calidad de la erección como a la consecución del estado de flacidez. En esta revisión, tras una breve visita a los orígenes históticos de la cirugía de la prótesis peneana, describimos meticulosamente comose implanta la prótesis y los pasos técnicos que permiten conseguir la operación con éxito. Finalmente, proporcionaremos algunas reflexiones sobre los últimos desarrollos en este campo, que incluyen los implantes de base estrecha, el reservorio valvular sin escape y los implantes cubiertos de antibiótico (AU)

Long-term outcomes of inflatable penile implants: reliability, patient satisfaction and complication management.

Despite the revolutionary introduction of oral erectogenic agents for the treatment of erectile dysfunction, there will always be patients who do not respond to conservative therapy. Penile prosthetic surgery remains an important option for these patients. Mechanical reliability and patient satisfaction have improved significantly throughout the years. This review focuses on the most recent and important updates regarding product enhancements, patient satisfaction studies, and management of intra- and postoperative problems.