TY - JOUR AU - Westney, O. Lenaine AB - Postprostatectomy Incontinence, Artificial Urinary Sphincter, Inflatable Penile Prosthesis, Erectile Dysfunction, Transcorporal INTRODUCTION Despite advances in patient selection, surgical technique, and the perioperative rehabilitation of urinary continence and sexual function, functional complications related to the surgical treatment of prostate cancer persist. Urinary incontinence (UI) and erectile dysfunction (ED) are most commonly reported and are associated with significant physical, psychological, and interpersonal distress. The surgical management of severe and/or refractory UI and ED includes the artificial urinary sphincter (AUS) and inflatable penile prosthesis (IPP), respectively. These surgical procedures may be performed in a dual synchronous or staged (metachronous) manner for men who have failed conservative management, depending on individual clinical presentation and the progression of symptoms over time. In some cases, patients may require de novo AUS placement along with IPP revision. There is a clear advantage of simultaneous dual implant placement with respect to total costs and operative time. Sellers et al., noted a shortened operative time of 24.7% and total cost savings of $7,000 when combined AUS and IPP placement was performed via a single transverse scrotal incision when compared with staged placement.1 However, complication rates are reported to be higher during dual implant placement with rates of erosion being higher for AUS+IPP compared with AUS alone (11.6% vs 4.3%, P = .037).2 As well, shorter operative times are associated with a lower infection rate and therefore avoiding a prolonged procedure for combined placement would reduce the risk of exposing both components to infection. Finally, Medicare and some commercial insurance companies do not reimburse the hospital and the surgeon at the same rate for a second simultaneous implant.3 Understanding the different surgical approaches and techniques for the implantation of the AUS and IPP are critical in preoperative counseling, surgical planning, recognizing intraoperative challenges, and maximizing postoperative outcomes and satisfaction. A careful preoperative evaluation along with astute intraoperative decision making is requisite to prevent damage to the existing IPP and its components. The specific focus of this article is to highlight the perioperative and surgical considerations in the placement of the AMS 800 AUS (Boston Scientific, Minnetonka, MN) in patients with an IPP in-situ. PREOPERATIVE EVALUATION AND PREPARATION Clinical Evaluation Prior to embarking on primary AUS placement or revision surgery in the setting of a prior IPP, a thorough clinical evaluation is warranted to assess patient symptoms, recognize potential intraoperative challenges, formulate a surgical approach, and frame postoperative expectations for patients. Many patients will have undergone pelvic radiation therapy (RT) in either the primary or salvage setting. A history of RT will alert the surgeon to the potential for fibrosis and compromised vascularity that may increase the difficulty of tissue plane dissection and guide the approach for cuff placement. Historically, our practice has been to perform cystourethroscopy and urodynamic studies in all patients undergoing AUS placement with or without prior IPP to rule out urethral stricture disease, intravesical pathology, and to assess bladder storage and emptying dynamics. More recently, the authors have been transitioning from universal cystometrogram evaluation in all male incontinence patients to those with prior radiation or local therapy for prostate cancer associated with storage symptoms. Patients with vesicourethral anastomotic stenosis (VUAS) should be treated prior to AUS placement but approached carefully with respect to the choice of technique for urethrotomy and the duration of catheter placement. In particular, urethrotomy between the 2 o’clock and 10 o’clock urethra should be minimized or performed superficially to avoid corporal injury and the translocation of urine which may lead to IPP infection.4 Post-procedural catheter duration should be limited to less than 48 hours. It is important to elicit the patients experience with the IPP, their satisfaction, and its functionality. Some patients may no longer be sexually active and may desire its removal at the time of AUS placement. Long-term IPP patients (15–20 years) may notice reduced functionality and desire concomitant replacement at the time of de novo AUS placement. In a review of long-term follow up after penile prosthesis implantation, IPP survival was 53% at 20-years with 41% of patients still using the device.5 For patients that continue to use the device with satisfaction, all approaches need to support device protection and preservation. Review of the Surgical History It is critical to obtain and review prior operative reports, when available, for additional details regarding the IPP, surgical approach, reservoir placement, and any intraoperative difficulties that were encountered. Additionally, operative reports from previous abdominal or pelvic surgeries can be useful in guiding surgery. In particular, a history of complicated prostatectomy (i.e., anastomotic leak and/or disruption, pelvic hematoma, abscess) will alert the surgeon to the potential for VUAS or scarring in the region of the dissection from local tissue inflammation. A history of low anterior resection, abdominoperineal resection, and orthotopic ileal neobladder may increase the risk of intra-abdominal adhesions and bowel adherent to the deep pelvis which may prohibit retropubic pressure-regulating balloon (PRB) placement. Severe pelvic fibrosis following RT may produce an obliterated retropubic space. Surgeons should note the position of any abdominal ostomies when deciding on PRB placement. A history of vertical rectus abdominal muscle (VRAM) flap surgery for the closure of pelvic and perineal defects will exclude ipsilateral submuscular PRB placement. Finally, a history of inguinal surgery or inguinal hernia repair with or without mesh will increase the difficulty of PRB placement due to distorted fascial planes, fibrosis and external inguinal ring inaccessibility. In the case of bilateral inguinal mesh, the mesh may need to be incised and reconstructed to permit PRB placement. The Role of Cross-Sectional Imaging Recent cross-sectional imaging is critical in identifying any unusual or unanticipated anatomy such as a pelvic kidney, renal transplant, urinary diversion, or vascular graft. This is particularly true for new patients presenting from another facility. In addition to the anatomical survey, computed tomography (CT) can be helpful in locating the IPP cylinders, pump, reservoir, tubing and previous AUS PRBs and any other drain and retain fragments from prior surgery (Figure 1). Figure 1 Open in new tabDownload slide (A) Coronal CT images depicting left-sided IPP reservoir positioning (yellow arrow). (B) a left-sided pelvic kidney (red arrow) is noted in a patient with prior right-sided PRB placement (yellow arrow) following AUS insertion. Figure 1 is available in color online at www.jsm.jsexmed.org. The IPP pump, which may be located laterally or in the posterior midline of the scrotum can be spared from any capsular disruption by gentle and careful retraction if the location is identified on pre-operative imaging. In addition to CT, magnetic resonance imaging (MRI) offers superior evaluation of all IPP components due to its ability to distinguish fluid compartments and soft tissue abnormalities not captured on conventional CT. This additional imaging can help guide the approach to the patient with IPP related complications or device malfunction at the time of AUS placement.6 Optimization of Medical Conditions The optimization of comorbidities is associated with improved surgical outcomes through reduced rates of surgical site/implant infection and rates of device erosion. Poor glycemic control is associated with an increased rate of AUS erosion and infection. We aim for preoperative hemoglobin A1c values below 7 to limit these complications. The impact of diabetes mellitus has been evaluated in men undergoing AUS placement. In one study, the 5-year incidence of erosion/infection was greater in diabetics (13% vs 8%, P = .025) and on multivariable analysis, diabetes was independently associated with an increased risk of erosion/infection (HR 2.26, P = .02). In addition, there was a greater incidence of erosion or infection in patients with a higher postoperative glucose level (176 mg/dL vs 153 mg/dL, P = .04).7 Similarly, diabetes is associated with a significantly increased risk of IPP infection on multivariable analysis (HR = 1.32, P = .16).8 In addition, hypogonadism has been associated with inferior outcomes with respect to AUS erosion as testosterone deficiency is correlated with urethral atrophy. At baseline, about 45.1% of men undergoing AUS placement have low serum testosterone (< 280 ng/dL) levels with a median of 118 ng/dL.9 This is important given the predisposition of men with low serum testosterone (T) to develop postoperative cuff erosion. In a study of men with low T levels prior to AUS placement, low T was associated with an increased risk of cuff erosion (90%) when compared with men without low serum T (36.4%). In contrast, a history of androgen deprivation therapy (ADT) use prior to AUS placement was reported in 26% of patients but with no difference in complications or time to replacement.10 In practice, we have not routinely replaced testosterone in hypogonadal patients prior to AUS. However, in the individual with prior erosion and with no other contraindications, it should be considered. Pre-incision Preparation Surgical antibiotic prophylaxis is provided according to the American Urological Association guidelines with the administration of intravenous antibiotics within 60 minutes of incision.11 In the dual implant patient, the authors prefer Vancomycin (1 gram) and Gentamicin (1.5 mg/kg). Patients are placed in dorsal lithotomy position, hair clippers are used and the perineum, external genitalia, and lower abdomen are prepped in the standard manner with chlorohexidine. An Ioban dressing is placed to exclude the buttock from the surgical field. A 12–14F Foley catheter is placed into the bladder. INTRAOPERATIVE CONSIDERATIONS Planning the Incision There are several options when planning the surgical incision(s) including the standard perineal approach with counter incision in the inguinal or high scrotal locations. In some instances, all components can be placed using a single incision via either a transverse scrotal or perineal incision (Figure 2). The transverse scrotal approach is less favored for AUS placement after scrotal IPP placement on the basis of avoiding the IPP components. Incisional planning will depend on the location of the IPP reservoir and may require contralateral placement to prevent inadvertent device injury or entering the IPP pseudocapsule. Figure 2 Open in new tabDownload slide Intraoperative images of AUS placement in a patient with prior bone anchored sling and IPP following post-prostatectomy incontinence and erectile dysfunction. (A) the scrotal pump of the IPP is demonstrated. (B) urethral dissection reveals the location of the sling mesh (yellow arrow) with distal normal penobulbar urethra. (C) urethral cuff placement with tubing from IPP cylinders (yellow arrow). Figure 2 is available in color online at www.jsm.jsexmed.org. PRB and Pump Placement As previously stated, if prior surgical history suggests, retropubic PRB placement may be associated with an increased risk of bowel, bladder, or vascular injury; we favor a high submuscular placement. Although ipsilateral placement of the PRB with the IPP reservoir may be necessary if the contralateral side is inhospitable, the norm would be contralateral placement. Further, adjacent pumps potentially increase the difficulty of handling by the patient. Urethral Cuff Placement (Transcorporal) Perhaps the most challenging aspect of AUS implantation in patients with prior IPP is management of the atrophic urethra. In the patient with a urethral measurement of less than 3.25 cm, a standard cuff is unlikely to yield a satisfactory result. Thus, to supplement the urethral tissue, partial or full thickness tunica albuginea is a reliable option. For transcorporal placement, a decision must be made regarding leaving the cuff in contact with the capsule of the cylinders or tunical grafting. We do not routinely close the tunica due to the risk of narrowing the corporal lumen and impairing cylinder inflation and function. Further, the corpus spongiosum is far less vascular post-IPP implantation. However, if closure is deemed necessary then care with needle passage is critical. As well, graft augmentation may be required to close the defect without again narrowing the corporal lumen. There is insufficient evidence to conclude that corporotomy closure is required but some authors perform corporal biological grafting (ex. 6-ply acellular graft) to separate the penile cylinders from remaining in contact with the AUS cuff. In a small series utilizing this technique, all three patients were dry and reported normal IPP function.12 Encountering the IPP If components of the IPP are inadvertently encountered during the course of dissection for the AUS, care should be taken to minimize handling and resultant damage. If dissection and mobilization of the IPP tubing is required then the components should only be handled with shodded surgical instruments to avoid damaging the tubing. Cutting currents should be used at all times to minimize the risk of thermal injury. If tubing is exposed, irrigation with antibiotic solution using a mixture of vancomycin/gentamycin while avoiding any betadine-based irrigation should be performed due to a 9-fold increased risk of IPP infection when using betadine.13 This is an important consideration due to the concern of biofilm formation along the IPP.14 Any overlying tissue is then reapproximated over the exposed device to minimize the risk of infection impacting both devices in the postoperative period if an early infection develops. Catheterization and Instrumentation In the case of a de novo AUS, placement can often be accomplished without placement of a foley catheter. However, if a small caliber foley is used, it should either be removed at the termination of the case for discharge or in 12–18 hours in the observation patient. Cystoscopic evaluation after cuff placement to evaluate coaptation should be avoided. Visual inspection of cycling and cuff competence should be sufficient and potentially reduces infectious risk. POSTOPERATIVE MANAGEMENT AND OUTCOMES Postoperative management is largely similar to AUS placement alone. In the case of urinary retention, catheter duration should be limited to no more than 3 days with double implant patients. If retention continues, suprapubic tube placement with imaging guidance must be considered. Standard activity limitations apply with respect to sexual activity until after device activation. We routinely provide antibiotics for up to 24 hours after AUS placement with an additional short course for patients with an existing IPP, diabetes or recent urinary tract infection. CONCLUSION The IPP and AUS are commonly employed in the surgical management of ED and post-prostatectomy incontinence, respectively. These devices can be implanted either synchronously or in a staged manner depending on individual patient presentation. AUS placement following previous IPP is not straightforward due to the numerous patient and surgical factors that need to be considered to plan the ideal approach for optimization of patient outcomes and maximization of device function and longevity. STATEMENT OF AUTHORSHIP J.S.: was involved in the initial draft of the manuscript; T.G.S and O.L.W.: were involved in evaluating the draft critically and revising the manuscript. All authors were involved in the overall conception and structure of the manuscript. Acknowledgment None. REFERENCES 1 Sellers CL , Morey AF, Jones LA. Cost and time benefits of dual implantation of inflatable penile and artificial urinary sphincter prosthetics by single incision . Urology 2005 ; 65 : 852 – 853 . Google Scholar Crossref Search ADS PubMed WorldCat 2 Sundaram V , Cordon BH, Hofer MDet al. Is risk of artificial urethral sphincter cuff erosion higher in patients with penile prosthesis? J Sex Med 2016 ; 13 : 1432 – 1437 . Google Scholar Crossref Search ADS PubMed WorldCat 3 Khalil MI , Bramwell AK, Bhandari NRet al. Concurrent penile prosthesis and artificial urinary sphincter versus penile prosthesis and male sling: A national multi-institutional analysis of National Surgical Quality Improvement Program database comparing postoperative morbidity . World J Mens Health 2021 ; 39 : 75 – 82 . Google Scholar Crossref Search ADS PubMed WorldCat 4 Carson CC. Inflatable penile prosthesis cylinder failure after internal urethrotomy . Urology 1988 ; 31 : 6 : 510 – 511 . Google Scholar Crossref Search ADS PubMed WorldCat 5 Chierigo F , Capogrosso P, Dehò Fet al. Long-term follow-up after penile prosthesis implantation-survival and quality of life outcomes . J Sex Med 2019 ; 16 : 1827 – 1833 . Google Scholar Crossref Search ADS PubMed WorldCat 6 Thiel DD , Broderick GA, Bridges M. Utility of magnetic resonance imaging in evaluating inflatable penile prosthesis malfunction and complaints . Int J Impot Res 2003 ; 15 : Suppl 5 : S155 – S161 . Google Scholar PubMed OpenURL Placeholder Text WorldCat 7 Viers BR , Linder BJ, Rivera MEet al. The impact of diabetes mellitus and obesity on artificial urinary sphincter outcomes in men . Urology 2016 ; 98 : 176 – 182 . Google Scholar Crossref Search ADS PubMed WorldCat 8 Lipsky MJ , Onyeji I, Golan Ret al. Diabetes is a risk factor for inflatable penile prosthesis infection: Analysis of a large statewide database . Sex Med 2019 ; 7 : 35 – 40 . Google Scholar Crossref Search ADS PubMed WorldCat 9 McKibben MJ , Fuentes J, Shakir Net al. Low serum testosterone is present in nearly half of men undergoing artificial urinary sphincter placement . Urology 2018 ; 118 : 208 – 212 . Google Scholar Crossref Search ADS PubMed WorldCat 10 Domino P , Benfante N, Tin Aet al. Preoperative castrate level of testosterone does not impact outcomes after AUS placement . J Urol 2021 ; 206 : 3S : e380, PD22-01 Google Scholar OpenURL Placeholder Text WorldCat 11 Lightner DJ , Wymer K, Sanchez Jet al. Best practice statement on urologic procedures and antimicrobial prophylaxis . J Urol 2020 ; 203 : 351 . Google Scholar Crossref Search ADS PubMed WorldCat 12 Mendez M , Sexton S, Lentz A. Transcorporal artificial urinary sphincter placement in patients with prior inflatable penile prosthesis utilizing 6-ply acellular graft: A novel technique with resolution of climacturia . J Urol 2016 . Google Scholar OpenURL Placeholder Text WorldCat 13 Manka MG , Yang D, Andrews Jet al. Intraoperative use of betadine irrigation is associated with a 9-Fold increased likelihood of penile prosthesis infection: results from a retrospective case-control study . Sex Med 2020 ; 8 : 422 – 427 . Google Scholar Crossref Search ADS PubMed WorldCat 14 Herati AS , Lo EM. Penile prosthesis biofilm formation and emerging therapies against them . Transl Androl Urol 2018 ; 7 : 960 – 967 . Google Scholar Crossref Search ADS PubMed WorldCat Author notes Conflict of Interest: O. Lenaine Westney MD is a consultant for Boston Scientific Jas Singh MD and Thomas G. Smith III MD do not have any COI. © International Society for Sexual Medicine 2022 TI - Artificial Urinary Sphincter Considerations in Men with Prior Inflatable Penile Prosthesis Placement JF - The Journal of Sexual Medicine DO - 10.1016/j.jsxm.2022.06.017 DA - 2022-08-06 UR - https://www.deepdyve.com/lp/oxford-university-press/artificial-urinary-sphincter-considerations-in-men-with-prior-D9pR0eAYNh SP - 1495 EP - 1498 VL - 19 IS - 10 DP - DeepDyve ER -