O implante de prótese peniana deve ser considerado o melhor método de restaurar a função erétil em homens com disfunção orgânica erétil (DE) refratária após falha ou rejeição de outras opções de tratamento em pacientes com motivação sexual.
Os urologistas têm de realizar histórias médica e sexual (anamnese) e exame físico cuidadoso antes do implante de prótese.
O paciente deve ser informado sobre as opções de tratamento alternativas, expectativas adequados, aumentar os riscos associados com a diabetes, a implantação prévia, tabagismo ativo, e outras comorbidades.
O paciente submetido a implante peniano deve ser informado sobre os potenciais riscos no pré-operatório de complicações e/ou insatisfação, incluindo a infecção e as suas consequências, dor, diminuição do comprimento e perímetro peniano, o prejuízo para os tecidos circundantes, e falha mecânica.
Ao usar uma prótese inflável, e com base na viabilidade, os cirurgiões devem usar dispositivos de antibióticos impregnados ou com revestimento hidrofílico.
Os implantes maleáveis são recomendados para pacientes com destreza manual comprometida, mas pode ser apropriado em outros cenários clínicos.
Para a cirurgia de implante peniano, não há recomendações definitivas podem ser feitas em relação ao local de incisão, protocolo de limpeza pré-operatório e otimização de hemoglobina A1c do paciente.
Antibiótico pré-operatório com cobertura para bactérias gram-positivas e gram-negativas deve ser administrado com os níveis terapêuticos adequados antes de fazer a incisão cirúrgica.
Remoção de pêlos da genitália é deixada ao critério do cirurgião com o objetivo de evitar perturbações da pele traumáticas.
Sempre que possível, os cirurgiões devem usar preparações para a pele à base de álcool na sala de operações como a esfoliação local da cirurgia.
Técnicas para minimizar o contato da prótese com a pele do paciente no ato cirúrgico pode diminuir as taxas de infecção.
Local de incisão: peno-escrotal, infra-púbica, e sub-coronal são as três abordagens principais para inserir a prótese. O método escolhido é baseado no tipo de prótese, anatomia específica do paciente, história cirúrgica e preferência do cirurgião.
O médico deve fornecer adequado acompanhamento pós-cirúrgico para maximizar a satisfação do paciente, avaliar as complicações, e garantir a colocação do dispositivo apropriado.
A cirurgia de revisão do implante peniano deve incluir o uso de irrigação abundante na área de incisão, de preferência com antimicrobianos.
Para a infecção de implante peniano, os cirurgiões devem determinar se há a possibilidade da tentativa de resgate. Não há recomendações podem ser feitas a respeito de qual estratégia de resgate para usar regimes de antibióticos no pós-operatório.
Para o paciente com extrusão da prótese e fibrose corporal, cirurgiões devem estar preparados para executar manobras especializadas, tais como o uso de cavernotomias, corporotomias adicionais, e / ou escavação corporal.
Os pacientes com priapismo, quando irreversível e prolongado, pode ser oferecido implante de prótese cedo para preservar a função erétil e tamanho do pênis.
Ao realizar o implante peniano em pacientes com doença de Peyronie (PD), com deformidades penianas ou Disfunção Erétil associada, os cirurgiões devem realizar manobras de alinhamento adjuvantes, tais como modelagem, plicatura e corporoplastia, ou enxertia, conforme indicação.
Prosthetic devices have been used to augment, replace, or restore penile function for more than 500 years. The primary goal of PP insertion is restoration of normal erectile function to allow penetrative sexual activity, and with the introduction of inflatable devices more than four decades ago, the use of PPs quickly became the gold standard therapy for medically refractory ED. Ongoing improvements have greatly improved all outcome measurements, with contemporary studies reporting consistently high satisfaction and lower complication rates. Currently, the role for PP in the management of ED is well established with several devices available to permit prosthesis insertion in virtually any clinical scenario. A large body of evidence has described techniques for enhancing device insertion, preventing infection, and managing intraoperative and postoperative complications, which are reviewed in this article.
Notable device alterations
Several device enhancements have directly resulted in improvements in mechanical reliability, intra- and postoperative complications, revision surgery, and overall satisfaction. An understanding of the history of noteworthy modifications is essential to interpret outcomes in the literature accurately, including the true rates of mechanical and overall device survival. A detailed discussion of this history is beyond the scope of this article and is presented inTable 1.1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
Table 1Notable Milestones in Penile Prosthesis History
1500s Wooden splints or wooden pipe used to facilitate urination
1936 Tubular phalloplasty with rib cartilage4, 5
1952 Acrylic splints, extracavernosal implantation6
1958 Paired intracavernosal polyethylene rods7, 8
1960 Intracavernosal acrylic rods9
1964 Silicone penile implants1
1973 Small-Carrion prosthesis with customizable length, enhanced girth, more reliable, easier placement10
1973 Introduction of inflatable penile prosthesis2
1977 Flexirod with soft hinge improved concealment11
1980 Jonas silicone prosthesis with silver wires; first true malleable device12
1983 AMS 700 with thick cylinders, PTFE sleeves, sutureless connector
1983 Mentor 3-piece IPP had polyurethane (Bioflex) that enhanced strength over silicone
1983 AMS 600M and 650 were malleable devices with a central wire core and trimmable silicone
1985–1986 Omniphase and Duraphase had a central cable and frequent mechanical malfunction13; Hydroflex and Flexi-Flate had poor concealment and incomplete flaccidity
1986 Kink-resistant tubing added to AMS 700
1987 AMS 700 CX had a 3-ply design with woven fabric layer and decreased cylinder aneurysms
1987 Mentor IPP improvements of pump modifications, nylon-reinforced tubing, cylinder base reinforcement
1989 Mentor Alpha-1, a connector-less IPP, decreased connector complications
1990 AMS 700 CXM, a narrow version
1990 AMS Ultrex had expanded girth and length
1992 Mentor Alpha-1 had reinforced pump and tubing and enhanced mechanical reliability
1993 AMS Ultrex cylinders were strengthened and improved mechanical reliability
1994 AMS Ambicor, a 2-piece prosthesis
1996 Mulcahy salvage technique14
1998 Mentor Acu-Form malleable device with central wire cores
2000 AMS 700 had Parylene coating added, which improved mechanical reliability; pre-connected cylinders with color-coded tubing facilitated implantation
2000 Mentor had a lockout valve
2001 AMS InhibiZone was impregnated with antibiotics minocycline and rifampin
2002 Mentor Titan had hydrophilic coating that permitted absorption of aqueous antibiotic solutions and decreased bacterial adherence
2002 Mentor Alpha-1, narrow base model
2004 Coloplast Genesis malleable
2006 AMS Momentary Squeeze
2006 1-way valve decreased autoinflation
2006 Coloplast acquires Mentor
2007 AMS 700 LGX trademarked
2008 Coloplast one-touch release pump
2008 Titan XL cylinders (24, 26, 28 cm)
2009 AMS Spectra malleable
2011 Conceal Cloverleaf CL reservoirs
2011 No-touch technique decreased infection3
2012 Coloplast 0° tubing and molded silicone contoured tip
AMS = American Medical Systems; IPP = inflatable penile prosthesis; PTFE = polytetrafluoroethylene.
The development of silicone was critical for the success of the penile implant. With the increased pliability of silicone, novel devices were technologically feasible, and in 1973, the IPP heralded a new era of penile implants. Silicone greatly decreased infection rates and offered a biocompatible, flexible, and resilient material that continues to be used in many contemporary devices.1 The enhancements with inflatable devices improved the ability to achieve truly erect and flaccid states while optimizing concealment, decreasing erosion, and permitting urethral instrumentation when required.2, 15
In 1983, a proprietary polyurethane, Bioflex, was used with the Mentor (now Coloplast; Minneapolis, MN, USA) three-piece IPP and provided significant improvements in penile cylinder strength. This decreased the rate of cylinder aneurysms and fractures and provided enhanced strength over silicone. To address the inherent limitations of silicone compared with Bioflex, American Medical Systems (AMS; Minnetonka, MN, USA) incorporated a woven fabric layer and three-ply system to devices in 1987, which helped provide additional strength and restrict expansion of the silicone, thus decreasing cylinder aneurysms.
One early challenge with placement of penile prostheses was frequent kinking of the device tubing. The later development of kink-resistant tubing (AMS, 1986) and nylon-reinforced tubing (Mentor, 1987) and the introduction of connector-less devices (Mentor, 1989) and pre-connected cylinders (AMS, 2000) served to decrease tubing-related complications. Parylene coating was introduced by AMS in 2000, which enhanced the mechanical strength of the devices. This improvement resulted in significant decreases in mechanical failure and related complications.16 Although not directly related to improving mechanical reliability, the introduction of antibiotic impregnation (InhibiZone; AMS) and hydrophilic coatings (Titan; Coloplast) represent significant milestones in device manufacturing with resultant decreases in infection rates.
Indications for surgery
For men with ED alone, PPs are often considered third-line therapy after inadequate response or inability or refusal to use phosphodiesterase-5 inhibitors, intraurethral or intracavernosal injections, and vacuum erection devices. Men with combined ED and PD requiring surgical management could benefit from earlier placement of a PP, particularly in cases in which the patient is poorly responsive to phosphodiesterase-5 inhibitors.16, 17, 18, 19The previously held notion that a PP is the last resort for treatment of ED should be reconsidered, because the PP could be the best option depending on the clinical scenario.
In addition to clinical indications, appropriate patient selection is an important aspect of PP surgery. Certain patient characteristics can place candidates at higher risk for postoperative dissatisfaction and should be taken into account when discussing placement of a PP.20Similarly, appropriate and thorough informed consent is an essential component of patient education, with postoperative satisfaction relating in part to established preoperative expectations.21
The operative decision to place a malleable, two-piece, or three-piece IPP is based on several factors, including patient preference, surgeon experience, indication for procedure, manual dexterity, penile size, and mental function. Malleable devices require less manual dexterity by the patient and can be performed under local anesthesia. Given the nature of malleable devices, they are less prone to malfunction; however, they are permanently firm and have lower overall satisfaction compared with three-piece devices.22, 23, 24 Two-piece IPPs do not require placement of a separate reservoir and therefore can be used in cases in which reservoir placement is problematic, such as after major pelvic surgery or renal transplantation. With the lack of a distinct reservoir, the two-piece devices do not permit complete deflation of the penile cylinders.25, 26, 27
The most common device implanted in penile surgery is the three-piece IPP. In a recent study, which aimed to evaluate the modern use of PP surgery, IPP placement accounted for 96.2% of procedures, whereas semirigid prosthesis placement represented 3.8% of procedures.28 In another National Practice Pattern analysis, the overall proportion of IPP compared with malleable prosthesis increased from 2.3:1 in 2003 to 25:1 in 2012.29 The same analysis concluded that although specialists and high-volume surgeons perform a disproportionate number of implants, low-volume surgeons (defined as implanting no more than four prostheses per year) perform most IPP implantations (75%) in the United States.
Contemporary devices and surgical considerations
Currently, several PPs are available, with the most commonly placed manufactured by AMS and Coloplast. AMS manufactures three three-piece IPPs (AMS 700 CX, CXR, and LGX) and Coloplast has two currently available models (Titan and Titan NB). There are several distinctive differences among the various prostheses. For cylindrical strength, AMS uses a three-ply woven fiber technology with Parylene coating to limit the extent of expansion circumferentially (CX and CXR) and longitudinally (LGX), whereas Coloplast uses Bioflex as the base material for the cylinders that is more resilient to sheer forces than silicone.
THE JOURNAL OF SEXUAL MEDICINE, April 2016Volume 13, Issue 4, Pages 489–518
Laurence A. Levine, MD, Edgardo Becher, MD, PhD, Anthony Bella, MD, William Brant, MD, Tobias Kohler, MD, Juan Ignacio Martinez-Salamanca, MD, Landon Trost, MD, Allen Morey, MD