Technological advances in penile implants: past, present, future.

Attempts to "cure" erectile dysfunction (ED) are as old as recorded history. The history of penile prosthetic devices dates back over 500 years, when a French military surgeon designed the first known wooden prosthesis to support micturition. There have since been a great many technological advancements in penile prosthetics. Penile implants for the improvement of sexual function date to the twentieth century. Like all human endeavors, penile prosthesis innovations have progressed via trial and error. This review aims to provide an overview of penile prostheses for the treatment of ED since their introduction in 1936. More specifically, we aim to highlight important advances in penile prosthesis development and discuss dead ends that were abandoned. Highlights include two-piece inflatables, three-piece inflatables, and malleable/semirigid, along with modifications and updates to each basic design that improved both insertion and usability. Dead ends include innovative ideas that were lost to history due to a variety of factors. We also look to the future and discuss expected advances, including remotely activated devices and prostheses designed for special populations, including transgender men.

Penile prosthesis salvage: a historical look at the Mulcahy technique and a review of the latest literature.

Historically, management of inflatable penile prosthesis infection was explantation of the device with delayed reimplantation at a later date. In 1991, this paradigm was challenged when early attempts at washout and immediate salvage proved successful. The clinical experiences and data generated over the past 30 years have allowed implanters to refine their salvage procedures to improve patient outcomes. In this article, we review the original Mulcahy technique for salvage and discuss updates to this protocol based on recent data.

Twenty years later: is the scrotal one-incision AUS of value?

The artificial urinary sphincter, known as AMS 800, has been the gold standard for treating moderate to severe stress urinary incontinence in males for 40 years. Yet, the number of sphincters done globally is quite small and the majority of urologists doing them are infrequent implanters. Estimates for 2019 showed half of implanters did only one implant that year and worldwide only around 13,000 implantations were performed. The traditional two-incision technique of perineal exposure for cuff placement and abdominal incision for pump and pressure regulating balloon persists as the most common technique to surgically place an artificial urinary sphincter. Present estimates are that upwards of 80% are done via the perineal approach and that approach is the highly favored incision of large volume centers. The scrotal one-incision approach was invented by Wilson 20 years ago and was aimed at making the implantation of a sphincter quicker, easier and safer for the occasional implanter. These physicians perform 1-2 devices per year, comprise 60% of implanters who perform the surgery yearly, and implant 22% of all implanted devices. Our article targets these infrequent inserters discussing the history of the two techniques and what the authors have learned about the advantages and hazards of the one scrotal incision procedure over the last two decades.

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?

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.

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.

The Development of Modern Penile Implants.

INTRODUCTION: Modern penile implants were introduced to the marketplace more than 40 years ago and were the first effective treatment of organic erectile dysfunction. The original devices were effective in restoring erections but were prone to early malfunction. AIM: This article describes the penile implants tested in clinical trials and chronicles the changes implemented by penile implant vendors in perfecting their products to improve device longevity, ease of use, and patient satisfaction. METHODS: The narrative is divided into six sections, three for inflatable implants and three for the semirigid rod-type devices. The inflatable category includes the three-piece inflatable, the two-piece inflatable, and unitary or self-contained inflatable prostheses. The semirigid rod types consist of soft semirigid, malleable, and mechanical implants. MAIN OUTCOME MEASURES: These include ease of use, longevity of function, and patient and partner satisfaction. These parameters determine the success or failure of a particular product. RESULTS: Those devices producing the best rigidity and flaccidity (ie, the three-piece inflatables) have increased in popularity and hold the largest market share. Implants not performing well in providing these two qualities have a smaller sales volume or have been discontinued. CONCLUSION: Penile implants have provided a predictable and reliable way for restoring erections in those patients in whom more conservative measures have failed. Vendors have reinforced or eliminated areas of these devices that were prone to wear and have made them easier to operate. The currently available models have very good durability and patient satisfaction.

The Prevention and Management of Noninfectious Complications of Penile Implants.

INTRODUCTION: Penile implants have been a mainstay in the treatment of erectile dysfunction for more than four decades. The satisfaction rate with the functioning of these devices has been very high. Problems can develop with the device itself or with the tissues surrounding it. Knowledge of preventing and managing these adverse events is critical to a successful outcome and sustained patient satisfaction. AIM: A narrative of the prevention and management of noninfectious complications of penile implant placement gained from the author's extensive experience is presented. METHODS: Each category of penile implant complications is presented as a separate subtitle. The initial categories are intraoperative problems; the subsequent groups involve postoperative adverse events. MAIN OUTCOME MEASURE: To gather information for this manuscript, I reviewed 40 publications and found 32 relevant and helpful. RESULTS: Attending to the details necessary for proper placement of prosthetic parts during the initial surgery will minimize the chance of problems developing. Prompt attention to postoperative problems will thwart their progression to a more extensive adverse situation, which will be more difficult to remedy. CONCLUSIONS: Complications during penile implant placement and in the postoperative period may occur. Knowledge of maneuvers to avoid their occurrence and prompt attention to correcting problems as they arise are paramount to a successful outcome and to maintaining high satisfaction rates. Mulcahy JJ. The prevention and management of noninfectious complications of penile implants. Sex Med Rev 2015;3:203-213.

Current management of penile implant infections, device reliability, and optimizing cosmetic outcome.

Penile implants hold a major position in the treatment algorithm for patients with erectile dysfunction who find medications and vacuum erection devices ineffective or unsatisfactory. As with any surgical procedure, adverse events may occur. The infection rate associated with implant placement has been lowered to the range of 1 % or less due to multifactorial improvements including no-touch techniques, the use of antibiotic-coated devices, and improved quality measures in the operating room. Urologists have been proactive in employing techniques and procedures which minimize loss of erectile length, hence enhancing patient satisfaction. Flat reservoirs have been developed and techniques of placing these to avoid problems in the space of Retzius have reduced complication rates as well. Device reliability has improved to the point that penile implants are among the most durable mechanical surgical products that contribute to patient and partner satisfaction, which is by far the greatest among all the treatments of erectile dysfunction.

Long-term infection rates in diabetic patients implanted with antibiotic-impregnated versus nonimpregnated inflatable penile prostheses: 7-year outcomes.

BACKGROUND: Diabetic patients may be more prone to penile-implant infections than other men. OBJECTIVE: We sought to determine whether revision surgeries due to infection were less common in diabetic men after implantation of an inflatable penile prosthesis (IPP) impregnated with minocycline and rifampin (M/R) versus a nonimpregnated prosthesis. DESIGN, SETTING, AND PARTICIPANTS: Infection-related revisions for M/R-impregnated and nonimpregnated implants were compared during a retrospective review of patient-implant and removal data recorded in the manufacturer's database. The data set included men with diabetes as an etiology of erectile dysfunction and who were implanted with their first IPPs between 2001 and 2008. INTERVENTION: All men received three-piece IPPs. MEASUREMENTS: The number of first revisions due to infection reported at any time during the study period were summarized for each group. Freedom from infection-related revisions for initial M/R-impregnated implants were compared to nonimpregnated implants with ≤ 84 mo of follow-up using life-table survival analysis. Infection-free survival was also compared for diabetics versus nondiabetics. RESULTS AND LIMITATIONS: Mean age was 59.1 yr for the 6071 diabetic men in the M/R-impregnated group. The nonimpregnated group included 624 diabetics with a mean age of 57.6 yr. Initial revisions due to infection were reported for 1.47% of M/R-impregnated versus 4.17% of nonimpregnated implants. At 7 yr, the rate of infection-related revisions was significantly lower for M/R-impregnated (1.62%) than for nonimpregnated implants (4.24%; log-rank p < 0.0001). Diabetic men had a significantly higher rate of revisions due to infection at 7 yr (1.88%) than men without diabetes (1.53%; log-rank p = 0.0052). CONCLUSIONS: This long-term evidence from the largest known database of diabetic IPP recipients establishes that the use of an antibiotic-impregnated IPP can decrease revisions due to infection. Reducing the incidence of this devastating complication represents a significant medical advance in erectile restoration for diabetic patients.

Long-term infection outcomes after original antibiotic impregnated inflatable penile prosthesis implants: up to 7.7 years of followup.

PURPOSE: Although some studies suggest that most infections associated with inflatable penile prosthesis implantation develop within year 1 after surgery, device related infections have been reported 5 years after implantation or later and the infection risk with time is not well characterized. We previously reported a statistically significantly lower infection rate for original inflatable penile prostheses impregnated with antibiotic treatment with minocycline and rifampin vs nonimpregnated inflatable penile prostheses at 1-year followup. Long-term data are now available on infection revision after initial implantation of antibiotic impregnated vs nonimpregnated prostheses. MATERIALS AND METHODS: We retrospectively reviewed patient information forms voluntarily filed with the manufacturer after the initial implantation of more than 39,000 inflatable penile prostheses to compare the revision rate due to infection for antibiotic impregnated vs nonimpregnated implants between May 1, 2001 and December 31, 2008. Life table analysis was used to evaluate device survival from revision surgery. RESULTS: On life table survival analysis initial revision events due to infection were significantly less common in the impregnated vs the nonimpregnated group (log rank p <0.0001). At up to 7.7 years of followup 1.1% of 35,737 vs 2.5% of 3,268 men with impregnated vs nonimpregnated implants underwent initial revision due to infection. CONCLUSIONS: To our knowledge this long-term outcome analysis provides the first substantial clinical evidence of a decrease in costly infection related revision using an antibiotic impregnated inflatable penile prosthesis.