At the turn of the millennium, the American Urological Association (AUA) asked each specialty society to identify the most influential publication of the twentieth century (1900–1999) that promoted growth and evolution of their field. According to Dr. Ira Sharlip (personal communication, November 2024), the consensus of the Sexual Medicine Society of North America was “The management of erectile dysfunction: the use of implantable inflatable penile prosthesis” by F. Brantley Scott and colleagues in 1973 [1]. This landmark paper energized research, clinical investigation, and surgical advances in sexual medicine in a multitude of ways. Cavernosal tissue obtained at the time of penile prosthesis (PP) implantation enabled laboratory studies that delineated the physiology and pharmacology of the erectile mechanism. Soon to follow were the development of vasoactive and vasoconstrictive agents (PDE5 inhibitors and vasoconstrictors) for the treatment of erectile dysfunction (ED) and priapism. Clinical studies demonstrated improvements in quality of life and psychological well-being of men suffering from and treated for ED. Advances in materials and surgical techniques continue to advance our field for the betterment of mankind. In short order, a tremendous economy has developed, stimulating new companies, employing healthcare workers, and successfully treating millions of ED patients.
Of course, the introduction of the inflatable penile prosthesis (IPP) represents only a single, but important, point in time in the quest to treat ED. In the 1930s and 1940s, the Russian military surgeon Bogoras implanted rib cartilage segments into abdominal-tubed phalloplasties in men who had lost their penis in military combat [2]. The rationale was that the solid os penis in mammals (including canines) provided penile rigidity for penetration. Unfortunately, inadequate length and host resorption limited long-term efficacy of this truly advanced concept.
Subsequent developments in the 1950s and 1960s included extracavernosal polyethylene rods, intracavernosal implants, and infection-reducing silicone devices [3, 4]. After the introduction of the IPP, the 1980s witnessed the commercialization of prosthetic options for the treatment of ED by numerous companies. Competition led to further improvements in materials and design. Examples include kink-resistant tubing, lockout valves to prevent autoinflation, easier pump-release systems, hydrophilic and bacterial-resistant coatings to prevent infection, reduced reservoir profiles, zero-degree tubing exit angles, narrow-based cylinders, and reinforced materials [5].
The aging population, with more comorbidities that cause ED, has led to new challenges for clinicians, surgeons, and companies. We can expect further progress in this realm. As an example, elderly men may not have the dexterity or hand strength to manage a scrotal pump. Development of automated or electronic controls (e.g., mobile phones) to inflate and deflate the hydraulic systems are currently under development and in clinical trials [6].
Other special populations (e.g., female-to-male transgendered patients) with reconstructed neophalluses have available early-phase devices with an enlarged single cylinder, blunted tips to prevent distal erosion, and incorporated stainless steel plates, which fix to the public bone to provide stability. Similarly, PP with impregnated antifibrotic agents for cases of significant fibrosis (e.g., priapism, postoperative infection, Peyronie’s disease (PD)) will likely come into existence in the coming decades.
Another issue is that the globalization of healthcare has brought many men suffering from ED in developing countries into the fold. Men with medication-refractory ED will be seeking prosthetic options. The disparity in incomes and lack of universal medical coverage will undoubtedly lead to the development of more cost-effective devices that are easily implanted on an out-patient basis, with hopefully fewer complications and increased satisfactory outcomes.
The general indication for PP implantation as a treatment for medication-resistant ED is well established. Numerous retrospective studies demonstrate superior results regarding rates of infection, complications, mechanical reliability, and overall patient and partner satisfaction. However, there are a paucity of prospective or randomized-controlled studies on this subject, with a limited number using standardized questionnaires or objective measures. These are still needed.
The following recent IJIR articles represent the cutting edge of contemporary, as well as sometimes controversial perspectives, on the subject of PP implantation for the treatment of men with ED.
Bibliometrics is a widely used method for examining academic publications and quantitatively analyzing knowledge through mathematical and statistical methods. Li et al. used CiteSpace and VOSviewer to analyze the knowledge distribution of PP surgery [7]. A total of 1,015 publications were retrieved, with a major uptrend in the number of manuscripts published over the last few years, half of which originated from the USA. Their analysis suggests that current research on PP surgery focuses on four main areas (1): complications of PP surgery (2), the current status of IPPs (3), the use of PP in populations with a history of radical prostatectomy and PD, and (4) patient satisfaction.
Van Huele et al. stated that the basis of patient dissatisfaction after an IPP is related to deficient preoperative counseling and the creation of unrealistic expectations. The authors identify keys areas that should be discussed preoperatively with the patient and recommend providing a flowchart for guidance [8]. Their general strategy is to underpromise and overdeliver to ensure high postoperative patient satisfaction.
Hawks-Ladds et al. reviewed patient characteristics and intraoperative factors in 530 patients implanted with an IPP in a large, urban, multiethnic hospital with a high volume of IPPs [9]. Primary outcomes were reoperation due to any reason and reoperation due to infection. Overall, 12.1% of patients underwent reoperation, primarily due to infection (5.5%) at a median time of 4 months. Analysis revealed an increased likelihood of reoperation with PD, HbA1c > 8, and active smoking. Reoperation due to infection was also associated with the infrapubic approach and hypertension. Of note, long-term data was limited here due to loss of follow-up in this large urban, blue-collar population.
Another study showed that ED increases with age. Unfortunately, only 10% of men with sexual problems actually seek medical attention, meaning that 70% of men with ED remain untreated [10]. Following the AUA guideline-recommended treatments, both transurethral alprostadil and intracavernosal injection therapy were associated with the highest annual out-of-pocket costs, while generic PDE5 inhibitors and PP insertion were associated with the lowest annual out-of-pocket costs for US Medicare patients. While the vacuum erection device (VED) had the lowest annual cost, the authors opine that this is only a moderate guideline recommendation. Despite having a lower satisfaction rate, the authors have misinterpreted the cost-basis analysis when evaluating VEDs. The point of the accompanying commentary is that treating clinicians should discuss the cost issue with their patients. Price transparency is needed from pharmacies, hospitals, and insurance companies in the future of healthcare reform [11, 12].
PP infection remains a major concern. Increased operative time is postulated to lead to a higher risk of infection due to increased risk of colonization and subsequent biofilm formation. The etiology has been associated with skin contact and exposure to the aerobiome. Increased operative time, which raises infection rates, has been supported by orthopedic meta-analyses on total knee and hip arthroplasties. In the study of Madhusoodanan et al., swabs from rear-tip extenders and reservoirs were taken at 30-minute intervals for 3 h [13]. Advanced polymerase chain reaction and next-generation sequencing were performed and found no microbial growth at any time point. The study concluded that the operation room aerobiome did not cause IPP colonization or infection for at least 3 h. The commentary suggests that a shorter operative time and reduced infection rate are due to better and more experienced surgeons performing these cases [14, 15]. Additionally, laminar flow rooms and isolation bubbles have never reduced the infection rate of IPPs [16]. Realistically, it is likely that prosthetic skin contact is responsible for colonization, as demonstrated with the no-touch surgical technique [17].
Solid organ transplants have a higher rate of ED due to a greater number of comorbidities and factors associated with organ failure. A systemic analysis of 14 publications revealed a 11.5% complication rate, 5.9% mechanical failure, and 4.26% infection rate [18]. Of note, three-piece IPPs had a higher rate of complications related to the reservoir. Despite the immunocompromised status of solid organ transplant patients and their higher rate of infections, the authors conclude that PP implantation is a valid option for such patients.
Reducing narcotic use is a general theme for all postoperative care. In the study of Zhu et al., 449 patients who underwent IPP implantation between 2015 and 2022, 83% underwent pudendal nerve block (PNB) prior to surgery [19]. The PNB consisted of 0.5% ropivacaine (200 cc), 1% lidocaine (20 cc), and dexamethasone (4 mg) inserted medially at the ischial tuberosity. The authors report decreased time in the Post-Anesthesia Care Unit and reduced postoperative opioid analgesic requirements.
Ischemic priapism is a urologic emergency. After 36 h of ischemia, an option is to place a PP. Abou Chawareb et al. compared early versus late implantation in eight published articles [20]. The results demonstrated that early placement had better outcomes regarding pain relief, priapism resolution, prevention of penile shortening, and quicker resumption of sexual activity. However, the authors noted that early implantation still carries a high risk of edema, infection, and distal perforation. Delayed IPP implantation poses surgical challenges due to extensive fibrosis often encountered. The complication rate for early implantation was 3.37%, compared to 37.23% for late procedures. My personal experience is that excellent results are achieved when early implantation for ischemic priapism is performed within the first 6 weeks.
Moncada et al. advocate for placing a PP in men undergoing surgery for PD, even in the absence of ED [21]. In his cohort of 168 men with PD, who underwent mostly IPP, 33 patients (19.6%) did not have ED. Most patients, both with and without ED (87.9% and 88.9%, respectfully) were satisfied at 6 months. IPP is efficacious, reproducible, and has tissue-expanding/stretching properties, which can complement curvature correction in men with PD.
Corporal fibrosis presents a challenge in PP implantation. The use of narrow-diameter cylinder (AMS-700 CXR, Boston Scientific, Marlborough, Massachusetts, USA) can be extremely helpful. Forty-nine patients underwent CXR cylinders for previous infection (67.3%), ischemic priapism (16.3%), and idiopathic fibrosis (16.3%) [22]. Postoperative complications occurred in 8 of 49 patients (e.g., infections, 2 herniations, 2 mechanical failures, 1 glans necrosis). The main complaints were shortened penile length and reduced growth, but the majority were able to have satisfactory penetrative intercourse.
Glans hypermobility (GH) is an underappreciated intraoperative occurrence. Of 530 IPP patients from two high-volume implanters, 139 (26.2%) had hypermobility [23]. Using a new scaling system (Grade 1, 2, and 3), GH was observed in 86 (18.2%), 29 (5.8%), and 24 (4.5%) cases for GH 1, 2, and 3 grades, respectively. Increased IPP size correlated with decreased GH. Eleven patients underwent repair with generally good results. The modified glanuloplasty technique described can be used to correct GH in any direction.
In a canine animal model conducted by Seyam et al., two adult male beagle dogs underwent tunica albuginea surgery with TachoSil® (Corza Medical, MA, USA) grafting [24, 25]. Six months later, histopathology evaluation of the grafting site was performed at sacrifice. No defects were visible, and no fibrosis was found on pathology, suggesting complete regeneration of the tissues. Hatzichristodoulou et al. present an 80-degree ventral PD curvature that underwent TachoSil® grafting on an IPP, yielding excellent results at 12 weeks [26]. The apparent advantages of TachoSil® grafts include self-adhesive properties (without the need for suture fixation), time-saving benefits, expanding capabilities (the graft does not contract), hemostatic effect, and cost effectiveness.
Synchronous dual implantation of an artificial urinary sphincter and IPP is not a new concept. Twenty-five patients, after treatment for localized cancer of the prostate, underwent dual implantations with a median operative time of 45 min and a median follow-up of 29 months [27]. There were no infections, 5 revisions, and approximately a 90% satisfaction rate. The advantages included faster return to normal urinary and erectile function with a single anesthesia session. Unfortunately, medical insurance reimbursement is often significantly reduced for a simultaneously placed device.
Scrotal hematoma after IPP implantation presents a challenge for most implanting surgeons. Braun et al. retrospectively reviewed 246 men who underwent PP surgery by two high-volume implanters [28]. One hundred and ninety-four (78.9%) were primary implants, and 52 (21.1%) were complex IPP cases, defined as revision, salvage with replacement, or performed with concurrent surgical procedures. Although drain outputs were comparable, the incidence of hematoma formation in the complex cases was 9.6%, compared to 3.6% in the primary cases.
In the study by Osmonov et al. on scrotal hematoma, group 1 (n = 114) had no drain, group 2 (n = 114) had a drain for 24 h, and group 3 (n = 117) had a drain for 72 h [29]. Group 3 demonstrated a lower incidence of hematoma at postoperative day 10 (0.9%), compared to group 2 (9.6%) and group 1 (7%). Five patients (4.4%) in group 1 and 4 patients (3.5%) in group 2 developed an IPP infection, versus 1 patient (0.85%) in group 3. The authors conclude that a 72-h drainage is advantageous after IPP implantation. Dr. Ralph comments that a drain is unlikely to increase the risk of infection, and surgeons should have a low threshold to leave a drain. He notes the surgical aphorism: You never regret leaving a drain in [30].
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Hellstrom, W.J.G. Advances in penile prosthetics: current trends and future directions in erectile dysfunction treatment. Int J Impot Res (2024). https://doi.org/10.1038/s41443-024-01010-5
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DOI: https://doi.org/10.1038/s41443-024-01010-5