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Critical Appraisal and Review of Management Strategies for Severe Fibrosis During Penile Implant Surgery
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SUPPLEMENT ARTICLE Critical Appraisal and Review of Management Strategies for Severe Fibrosis During Penile Implant Surgery Landon Trost, MD,* Mukul Patil, MD,† and Andrew Kramer, MD‡ *Department of Urology, Mayo Clinic, Rochester, MN, USA; †Department of Urology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA; ‡Department of Urology, University of Maryland, Baltimore, MD, USA DOI: 10.1111/jsm.12985
ABSTRACT
Introduction. Penile corporal fibrosis represents a challenging clinical scenario for surgeons placing penile prostheses (PP). Because of its rarity, a small number of series with limited follow-up have reported outcomes in this cohort. Aim. The aim of this study was to perform a critical appraisal of the corporal excavation technique, discuss its relevance to contemporary practice, and review alternative surgical methods and outcomes. Methods. A critical review was performed of the 2006 article by Montague and Angermeier, “Corporeal excavation: new technique for penile prosthesis implantation in men with severe corporeal fibrosis.” Notable inclusions and omissions were described, with emphasis placed on methodology and outcomes. A PubMed search from 1990 to June 2015 was then performed to review and summarize the literature on managing corporal fibrosis during PP surgery. Main Outcome Measures. The main outcome measures used were the major contributions and limitations of the 2006 article describing outcomes of the corporal excavation technique. Results. Corporal excavation is a relevant surgical technique for managing severe corporal fibrosis. Compared with alternatives, excavation achieves successful placement of PP without need for grafting and with few complications. The article was limited by several notable omissions including relevant patient demographic and disease characteristics, patient selection, and minimal descriptions of complications and outcomes. Alternative techniques include use of specialized dilators, counter incisions, reconstruction with graft placement, minimal scar tissue excision, and endoscopic resection. Because of limited data, no specific algorithm for managing corporal fibrosis can be prescribed. Conclusions. Corporal fibrosis is a challenging clinical scenario and requires surgical experience and specialized techniques to manage appropriately. Corporal excavation represents one of several viable techniques, which may be chosen based on surgeon’s preference and clinical factors. Trost Landon, Patil Mukul, and Kramer Andrew. Critical appraisal and review of management strategies for severe fibrosis during penile implant surgery. J Sex Med 2015;12(suppl 7):439–447. Key Words. Revision; Salvage; Erectile Dysfunction; Peyronie’s Disease
Introduction
P
enile corporal fibrosis encountered at the time of penile prosthesis (PP) implantation remains a challenging clinical scenario for prosthetic surgeons. Several etiologies may result in corporal fibrosis including long-standing erectile dysfunction (ED), Peyronie’s disease (PD), and diabetes mellitus, among others. The extent of fibrosis
© 2015 International Society for Sexual Medicine
encountered with these conditions is variable and often does not significantly impact surgical placement of PP. In other cases, particularly among patients with prior ischemic priapism or device explantation secondary to infection, fibrosis may be much more severe and limit the extent of dissection performed. Although these cases represent a relatively small percentage of implants overall, they may be associated with higher rates of intraJ Sex Med 2015;12(suppl 7):439–447
440 operative and postoperative complications, including perforations, crossovers, procedural abortions, supersonic transporter (SST) deformities, or infections. Therefore, descriptions of novel surgical techniques, which permit placement of PP while limiting adverse effects, are welcome additions to contemporary prosthetic surgery. Historically, several techniques preceded this first case series studying corporal excavation as a viable surgical option for the management of severe fibrosis. These included the use of synthetic, autologous, or xenografts, cavernotomes, electrovaporization of fibrotic tissue, corporal counter incisions, extended corporotomy, or multiple incisions with minimal scar tissue excision [1–7]. Each of these techniques exhibited varying limitations and side effect profiles. Cavernotomes were appropriate in cases where an initial channel for dilation could be established; however, their use was limited in cases of complete corporal occlusion and by the indirect nature of incisions performed. Counter incisions and minimal tissue excision permitted device implantation in even the most severely occluded corpora; however, adjunctive use of graft materials is frequently required to achieve coverage of the implant cylinders. These techniques were also associated with complications including perforation, infections, and inadequate dilation, support, and positioning of cylinders.
Trost et al.
Results of corporal tissue excavation Limited demographic information was available on the nine patients reported. Etiologies for the fibrosis included four with prior ischemic priapism, four with prior infected PPs, and one with diabetes mellitus and renal transplantation. Information was obtained via retrospective review of charts and patient telephone interviews. At a mean follow-up of 44 months (range 15–92), all patients continued to have a functional prosthetic, with one patient requiring revision for a malfunctioning device at 46 months. Seven patients required reduced diameter devices (AMS 700 CXM™), while two received standard sizes (AMS 700 CX™). Mean length of excised fibrotic corporal segments was 5.2 cm (range 4–7), and mean PP cylinder length was 13.8 cm (range 12–16). No patient required grafting, and all patients reported limited thrusting with intercourse, presumably due to inadequate functional penile length. The authors concluded that the current series supported the use of extensive corporotomies with tissue excavation in cases of severe corporal fibrosis. Suggested benefits over prior techniques included direct visualization and controlled excision of affected tissue without need for grafting. Aims
Description of corporal tissue excavation technique In this setting, Montague and colleagues presented a series of nine patients undergoing extensive corporotomy with corporal excavation at the time of PP implantation [8]. The technique was performed via a penoscrotal, ventral, inverted-T penile incision. This permitted complete exposure of the corpora bilaterally. Ventral corporotomies were subsequently made from the penoscrotal junction to the distal-most extent of the corpora. Metzenbaum scissors were next used to create a plane between the scarred corporal tissue and the tunica albuginea. This was carried circumferentially until a penrose drain could be placed to further assist with the dissection. The scarred fibrotic corporal tissue was then excised as distally as possible to provide a cavity for the PP (AMS, Boston Scientific, Marlborough, MA, USA; 700 inflatable PP [IPP]). Measurements were then obtained, and an appropriately sized device placed. The corpora were subsequently closed using preplaced horizontal mattress sutures. J Sex Med 2015;12(suppl 7):439–447
The original article by Montague and Angermeier presented several notable contributions, which are described in subsequent sections of the current review in greater detail. As with all articles, however, there were several relevant limitations and omissions, which may have improved the overall relevance and quality of the report. The objective of the current article was to critically review the original publication by Montague and Angermeier to evaluate notable omissions or errors which may have had an impact on the data or limit utility by subsequent readers. Each of the issues identified are organized by article section and are not rated or categorized for overall significance. Methods
A critical review was performed of “Corporeal excavation: new technique for penile prosthesis implantation in men with severe corporeal fibrosis” [8]. The report was analyzed for appropriate-
Corporal Excavation During Penile Prosthesis ness of title, methodology, description of the cohort, technique, and outcomes. All sections of the article were reviewed including the title, body text, images, and references. Style issues including the choice of references, narrative, discussion points, and location of material into various sections were not critically evaluated, as these were not felt to have a substantive impact on the overall relevance and quality of the article. To review the literature on corporal fibrosis, a PubMed search was performed of all publications reporting outcomes of techniques for placement of penile prostheses in men with corporal fibrosis. Given the relative paucity of literature in this area, all publications were initially included for review. Detailed analysis and reporting was not performed of all publications reporting outcomes of synthetic grafting materials, given their lack of relevance in contemporary practice. Main Outcome Measures
The primary outcomes included methodological and reporting factors which limited or reduced the quality and reliability of the article. Given the nature of the current publication, these were subjectively determined by the reviewers and did not rely on any objective measures. The secondary outcomes included a thorough review of the current literature on alternative techniques for managing corporal fibrosis. Emphasis was placed on how corporeal excavation fits within the literature as a whole and within current clinical practice. Results
The article title suggests that the technique is a novel procedure being described. However, as noted by the authors in the commentary section, the procedure had previously been reported nearly 20 years earlier [9,10]. The article may therefore be more accurately titled a report on outcomes of the corporal excavation technique with credit for the technique referenced in the introductory sections. The current article only minimally describes patient demographics and disease characteristics. Pertinent missing information includes patient ages, concomitant fibrosing conditions (such as PD), comorbidities, number of prior prosthetics, and time since the most recent explant or episode of priapism. The cohort itself also only represents a small group of patients. Most case reports in
441 contemporary literature require at least 10 cases to be considered for publication. However, given the relative rarity of severe corporal fibrosis necessitating gross excision, a smaller cohort is to be expected. Additional details regarding patient follow-up are notably absent. The number of patients being evaluated in the clinic versus those undergoing telephone follow-up should be indicated, with the date of last clinical follow-up and physical examination reported. Device issues relating to surgery including cylinder herniation or aneurysms, penile angulation, SST deformity, and discrepant distal positioning, among others would not have been identified with telephone interviews alone. Other missing data include the time period during which the procedures were performed and the total number of revision, salvage, and primary prostheses. These data would help to better contextualize the severity of disease represented by the cohort. If the patients included only a small percentage of all revision cases, this would suggest that they were a highly select group with severe disease. In contrast, if the cohort consisted of all salvage cases performed, it would suggest that the patients included those with lesser degrees of fibrosis, given that a large percentage of salvage cases can be appropriately managed with more conservative techniques. Another relevant issue with the study methodology involves patient selection. The authors did not discuss any inclusion or exclusion criteria. It is unclear if any alternative techniques were attempted prior to performing the excavation or if the authors utilized an algorithm for escalating intra-operative dissection. If other techniques were used, it would be helpful to know with what frequency these are performed successfully, and what percentage of patients will ultimately require a more extensive dissection. These missing data are particularly important given that the decisions as to when and on whom to perform a novel technique are equally as important as understanding the technique itself. The description of the surgical technique does not include any information on preoperative antibiotic protocols or methods used to reduce infection. Given the high-risk nature of salvage procedures in general, these data are relevant and help to compare outcomes against alternative techniques. Postoperative instructions, restrictions, and timing of device activation are also notably absent. As these factors are important in J Sex Med 2015;12(suppl 7):439–447
442 optimizing prosthetic outcomes, the lack of information may prevent others from reproducing and validating the findings. Limited discussion is also present on intraoperative management of the proximal corpora. It is expected that scarring in the proximal corpora was as significant as the distal corpora, which is supported by the finding that 7/9 patients required device downsizing for appropriate placement. It is unclear, however, if any corporal excavation was performed of the proximal corpora, or if any specific complications occurred during dilation. Several important findings are notably absent from the current article. Missing intra-operative data include total operative time, rate and extent of discrepant corporal lengths, presence of unilateral versus bilateral corporal excavations, and sidespecific lengths of resected cores. Complication rates are also significantly important in reporting outcomes of a novel surgical technique. Particularly with salvage PP cases, the rate or lack of proximal perforations, crossovers, and number of procedures attempted but aborted should be reported. Given the extent of dissection performed, the rate of wound breakdown, dehiscences, or other similar issues should be indicated. The current report is also very limited regarding patient and partner satisfaction outcomes. The authors note that “some” patients were unable to have penetrative intercourse with select positions, but fail to indicate how many patients this represents. Similarly, the report that all patients were only able to participate in “limited thrusting” should be better detailed. Terminology from nonvalidated subjective questions should be reported so as to better understand potential confounding issues with wording or interpretation. Several statements in the discussion are also unsupportable from the data provided within the article or would require references to support. The report that the current technique results in fewer medial/lateral perforations compared with dilatation techniques cannot be concluded based on the current findings. The authors did not present any data on other techniques, and therefore, no direct comparisons can be drawn. Also, data reported from other series of alternative techniques were not reviewed, further limiting any direct comparisons. See Table 1 for a review of alternative techniques for managing corporal fibrosis. Similarly, the statement that total cylinder length decreased is unsupportable without any data presented on prosthetic sizes with prior implantations. J Sex Med 2015;12(suppl 7):439–447
Trost et al. Another important factor not adequately discussed in the current article is why limited excision occurred despite a complete ventral corporotomy. With excavated tissue ranging between 4 and 7 cm, it is likely that subtotal excavation was achieved. Thus, the entire length of corporal tissue is not excised, nor did the authors address management of the remaining tissue. Similarly, only two of the nine patients were able to receive standard-sized devices, again suggesting significant limitations with corporal excavation as a technique. Readers are left to question how this approach is significantly different from the previously described multiple incision/minimal excision technique [5]? The logical question one might ask, is what is to be gained by excising just a segment or core of fibrotic tissue, and then placing the rest of the device through and around the scarred corpora as is well described in many other situations? The most treacherous issues for cylinder placement would be the most proximal and distal extents of the corpora, since these are further from the open incision and require potentially risky dilatation techniques. This approach leaves the scarred corpora in these dangerous locations, and only removes it in the safest area, the part closest to the incision. Surgeons have progressed toward less intrusive corporal access, going as far for some to exclude sequential dilatation or even any dilatation at all. Leaving some of the natural tissues behind may be thought to spare some of the blood supply, for healing, infection control, and ease of recovery. This technique seems to walk back a few steps in the spectrum of invasiveness, offering the most extreme approach.
Review of management techniques for corporal fibrosis Corporal fibrosis remains a significant challenge for the prosthetic surgeon in contemporary practice. Despite over 30 years of surgical technique development, the optimal strategy and surgical procedure has not been identified. See Table 1 for a summary of various techniques with reported outcomes. Corporal fibrosis represents a heterogeneous condition. Fibrosis may involve small or large segments of the corpora and may result in significant reductions in luminal diameter in many cases. The severity of fibrosis also varies significantly and ranges from minimal scarring to complete occlusion of the corpora. Optimal strategies to identify patients at high risk for corporal fibrosis have not
2006 (9)
Montague [8]
1996 (12)
1995 (20) 1995 (11)
George [18]
Knoll [19]
Cavernotomes
Grafting
Grafting
Downsized prosthesis
Grafting
Cavernotomes
Multiple incisions, minimal scar excision
Counter incisions
Grafting
44
48
58
56
60
56
38
58
46
20
22
24
10
12
18
44
1–12
91
32
26
PTFE—92%
None
PTFE—38%
Cadaveric pericardium— 100% None
None
Rectus fascia—100%
None
Rectus fascia—66% None—33% None
AMS 700CX—82% Jonas-9.5 mm—18%
PTFE—100%
PTFE—100%
Infection—90% Priapism—10% Explant—27% Infection—36% Priapism—18%
Infection—83% Priapism—17%
Infection—81% Priapism—19%
ICI—6% Infection—82% Priapism—12%
Infection—71% Priapism—29%
Erosion—100%
ICI—17% Infection—42% Priapism—33% Unknown—8% DM + Tx—11% Infection—44% Priapism—44% PD—47% Erosion—27% Explant—7% Infection—20% Priapism—100%
Infection—100%
Crossover—19% Crural perforation—38% Distal perforation—25% Infection—0% Malfunction—8% Revision—25% Infection—5% Revision—5% Infection—0% Malfunction—0% Revision—27% Infection—30%
Crural perforation—6% Infection—0% Revision—0% Crural perforation—3% Infection—0% Malfunction—3% Revision—12%
Complications—0%
Infection—0% Penile hypoesthesia—14% Satisfaction—100%
Malfunction—11%
Complications—0% Revisions—0% Complications—0%
Elective revision—22% Satisfied—71% Satisfied—100%
Etiology for fibrosis Outcomes
Porcine dermis—61% Infection—100% Collagen dermis—39% Bovine pericardium—100% Priapsim—60% Infection—40%
Graft
Downsized (dilated to 10 mm)—100% None
Duraphase-10 mm—41% Malleable-9.5 mm—47% Malleable-11 mm—12% Alpha-1—44% AMS 600—21% AMS 700—21% Semirigid—12% Mark-2—3% Alpha-1—13% Alpha-NB—75% AMS 700CXM—13% Semirigid—58% Inflatable—42%
Mentor-NB—100%
Alpha-1—47% AMS 700—53% - Unclear if reduced cylinder size
AMS 700CXM—78% AMS 700CX—22%
Standard inflatable—33% Malleable 13 mm—66%
Malleable
AMS 700CX—78% AMS 650 11 mm—22%
Mean Mean F/U age (mo) Device
*Data from 2008 study summarized; **Publication in 2008 with identical data; DM + Tx = diabetes mellitus and renal transplantation; F/U = follow-up; ICI = intracavernosal injection therapy; PD = peyronie’s disease; PTFE = polytetrafluoroethylene.
Rossello Barbara [21]
Knoll [20]
1992 (30) 1991
1999 (16)
Mooreville [4]
Herschorn [7]
1999 (34)
Rajpurkar [5]
Ghanem [6]
Palese [3]
Open resectoscope
Park [1]
2002 (1) 2001 (4) 2000 (17)
Grafting
Corporal excavation
Penoscrotal/perineal approach Ultrasound guided endoscopic resection
Grafting
Excavation with grafting
Technique
**Pathak [2,17] 2005 (15)
Shaeer [15,16]
Brusky [14]
Lopes [12,13]
2012 (18) 2009 2007 (5) 2008 (3) 2008* 2007 (12)
Year (n)
Outcomes of techniques to manage penile fibrosis during penile prosthesis implantation
Sansalone [11]
Author
Table 1
Corporal Excavation During Penile Prosthesis 443
J Sex Med 2015;12(suppl 7):439–447
444 been described. Anecdotally, and based on prior descriptions of cohorts, cases of prior penile infection with device removal and ischemic priapism represent some of the conditions more likely to result in severe fibrosis [6,8,12]. However, even in these settings, significant portions of nonfibrotic tissue may be encountered. Multiple techniques have been described to manage corporal fibrosis at the time of device implantation. Initial techniques primarily utilized direct incisions into the scarred tissue with or without graft placement [7,18,20]. Although this permitted device placement in the majority of cases, it frequently was time consuming and included the use of synthetic graft materials, which subsequently fell out of favor due to high revision and infection rates. Later descriptions of autologous, xenologous or cadaveric allografts demonstrated successful placements in all patients, with many able to receive standard-sized implants primarily [2,3,11,12,14]. Revisions range from 0% to 22% and satisfaction 71% to 100% at follow-ups of 10–91 months. To address some of the limitations with early synthetic grafting materials, specialized cavernotomes were developed. Rossello Barbara and Carrion initially reported on the use of a grooved dilator (Carrion-Rossello) to assist with corporal dissection [21]. The instrument was carefully introduced into the scarred tissue with rotating motions (similar to the action used with a wood rasp in carving) to create a channel for the PP. Mooreville and colleagues similarly introduced a modified cavernotome (Uramix/Mooreville) used in a rotating fashion to incise and abrade tissue in 1 mm increments. Although the devices enhanced available options for managing corporal fibrosis, they were best suited for cases in which an initial tract could be established and were ultimately less successful in creating initial tracts for dissection. Outcomes with the Mooreville dilator demonstrated reduced operative time and successful placement in 16 patients without need for grafting. However, only two patients were able to receive standard-sized implants, and complications included 38% proximal and 25% distal perforations (delayed recognition) [4]. The introduction of narrow-base prosthetic models (AMS 700 CXM™ 1990, Alpha 1 NB / Titan NB®, Humlebaek, Denmark, 2002) further increased options for managing severe proximal corporal fibrosis. In contrast to standard size cylinders, which require proximal dilation to a minimum of 12 mm, downsized cylinders may be placed in J Sex Med 2015;12(suppl 7):439–447
Trost et al. cases where only 10 mm of dilation is achieved. Initial outcomes from a series of 20 patients receiving downsized cylinder placement (AMS 700 CXM™) demonstrated a 5% infection rate, with 95% prosthetics functioning at a mean 20 months follow-up [19]. Although some patients will elect to continue with the down-sized devices, Wilson and colleagues reported the feasibility of subsequent device upsizing in a report of 37 men who successfully were converted to standard cylinders after 1 year with the smaller devices. In addition to cylinder diameter upsizing, results also demonstrated a mean 2.2 cm increase in overall implant length without reported complications [22]. Another notable, although preliminary, contribution to the management of corporal fibrosis includes use of a minimally invasive endoscopic approach. The proof of concept for the technique was initially introduced by Park and colleagues who used a resectoscope loop to dissect out scarred cavernosal tissue in one patient via direct cut-down access [1]. Shaeer and colleagues subsequently advanced the technique using a minimally invasive, endoscopic approach [15,16]. Resection of fibrotic tissue was performed under direct vision in a methodical and controlled process. In cases where an initial channel was unable to be developed, the Otis urethrotome (previously described by Mulcahy) and/or ultrasound-guided placement of a guidewire were used to assist in localization and limit complications [16,23]. Results from 12 patients undergoing the procedure at 1–12 months follow-up demonstrated no complications with successful placement of standard-sized devices in all patients without need for grafting. Given the preliminary nature of the report and lack of subsequent validation or follow-up, further study is required of this technique prior to routine implementation. The description of corporal excavation introduced several enhancements over earlier techniques. Compared with grafting, corporal excavation offered similar outcomes while maintaining the rigidity and structure of the native tunical tissue. Unfortunately, because of limited data presented in many grafting series, it is unclear if grafting is able to consistently achieve a significantly higher percentage of standard diameter cylinders compared with excavation alone. Corporal excavation also provided an alternative to cavernotomes, which were associated with higher rates of recognized and unrecognized corporal perforations and often required placement of smaller diameter cylinders [4]. When compared
445
Corporal Excavation During Penile Prosthesis Table 2 Advantages and disadvantages of techniques for managing severe corporal fibrosis at the time of penile prosthesis implantation Advantages
Disadvantages
Corporal counter incisions Corporal excavation
• Reduces need for graft placement • Able to dissect under direct vision • Reduces likelihood for unrecognized injury
Corporal reconstruction (Grafting)
• Able to dissect under direct vision • Reduces likelihood for unrecognized injury • Permits placement of standard-sized cylinders
Specialized dilators (CarrionRossello; Uramix/Mooreville)
• Reduced operative time • Additional corporotomies/extended incision not required • Can be combined with counter incision technique to reduce likelihood for complications • Minimally invasive • Permits placement of standard-sized cylinders
• Requires extensive corporotomy (excavation; not counter incision) • Lack of externally validating series • Frequently requires downsized cylinders • Requires graft placement • Likely increased operative time • Durability of graft and overall repair unknown (extrusions, cylinder aneurysms) • Risk of recognized and unrecognized perforations • Requires specialized instruments • Often requires reduced diameter cylinders
Endoscopic electrocautery resection
with the counter incision technique, similar benefits are achieved regarding reduced corporal perforations and avoidance of graft materials, with relatively similar rates of downsized cylinders required [6]. See Table 2 for a summary of advantages and disadvantages with various corporal fibrosis management strategies.
Contemporary role for corporal excavation The current role for complete corporal excavation is debatable. Since the original publication, longterm follow-up and externally validated series have not been reported. In view of the larger number of studies published using reconstruction with various grafting materials (including publications post-dating the description of corporal excavation), this would suggest that grafting is more widely utilized, and generalized adoption of corporal excavation has not occurred. It is unclear if the larger number of series describing the use of grafting materials is due to the relative ease of the technique over excavation or because of other factors. Similarly, subsequent publications describing alternative, minimally invasive techniques for the management of corporal fibrosis (i.e., endoscopic electrocautery dissection) would also suggest that the optimal technique for managing this difficult to treat issue remains elusive [15,16]. Corporal excavation clearly has advantages over alternative techniques, in that it permits placement of cylinders without need for grafting and allows direct dissection with ability to recognize and manage perforations accordingly. However, corporal excavation is also maximally invasive,
• Requires specialized equipment • Ultrasound guided placement of guide wire may require specialized skillsets • Anticipated learning curve • Lack of externally validating series
requires specialized skillsets, is likely overly aggressive in the majority of cases of corporal fibrosis, and has unclear benefits over less invasive techniques such as counter incision and endoscopic electrocautery resection.
Defining an algorithm Given the relative paucity of data, absence of comparative series, and heterogeneous nature of corporal fibrosis, it is not possible to suggest a definitive optimal strategy or algorithm for management. One exception to this is the recommendation to avoid use of synthetic graft materials because of their association with elevated infection rates. Specialized dilators and cavernotomes remain a viable option in select patients, particularly among patients where an initial tract for dissection can be obtained. However, even in this setting, it is unclear if the use of specialized dilators should be considered an optimal first-line approach, particularly given the relatively high rate of recognized and unrecognized complications reported [4]. Although cases where an initial tract is able to be established likely represent less severe underlying fibrosis, it is unclear if specialized dilators are able to achieve better proximal and distal cylinder positioning or improved dilation over standard dilating methods alone. It is also unclear if there are differing complication rates among patients treated with specialized dilators based on the ability to achieve an initial tract or not. In the absence of adequate data, the role for specialized dilators remains unclear. J Sex Med 2015;12(suppl 7):439–447
446 Perhaps corporal excision, or “excavation,” would be one of many tools that a surgeon possesses, although it would only be used in the most desperate situations involving impassable segments of corpora. If a dilating tool or Furlow instrument can bypass a scarred segment, the tissue expanding qualities of the devices would likely expand these difficult regions through cycling alone, rendering excavation largely unnecessary. However, if counter incisions are done, several dilating instruments employed, and there remains absolutely no space for a long length of corpora, then large-scale excavation could be a last ditch option. From an algorithmic standpoint, the role for corporal excavation likely fits with other extreme and seldom used options including grafting and other major penile reconstructions. Given the limitations with each technique, variable advantage/disadvantage profiles, and lack of definitive data, the ultimate decision as to how to proceed in each clinical scenario should remain at the discretion of the surgeon based on experience, comfort level, and clinical factors.
Future strategies Future management of corporal fibrosis will likely center on prevention. Several authors have suggested a role for early placement of PP in men with prolonged ischemic priapism [24–26]. Compared with a delayed approach, early placement is technically easier to perform, has fewer complication rates, and prevents loss of penile length associated with scar tissue contraction [24]. These benefits have also been recognized and are reflected in the most recent European Association of Urology guidelines on priapism [27]. Another strategy currently undergoing evaluation is the use of space holding materials at the time of infected implant removal. Preliminary data on the instillation of calcium phosphate into corpora following device removal suggests that it may provide a viable option to reduce subsequent scarring and facilitate delayed implantation [28]. Longer term data and further validation are required prior to routine implementation. The use of salvage washout techniques to manage infected PP will also further reduce the prevalence of significant corporal fibrosis. Although the optimal antibiotic regimen, washout protocol, and device to be used at the time of salvage surgery are not well defined, additional studies reporting outcomes will further support this J Sex Med 2015;12(suppl 7):439–447
Trost et al. therapy as a standard of care option for managing infected devices. Ongoing advancements in the management of ED will also likely further reduce the prevalence of corporal fibrosis. As novel treatments including shockwave therapy, tissue engineering, and new pharmacotherapies are developed, placement of PP may be delayed until later in life. This, combined with anticipated mechanical advancements and ongoing attempts at infection reduction in PP technology, will likely lead to a reduction in the relative frequency of revision surgeries required. Conclusions
The article “Corporeal excavation: new technique for penile prosthesis implantation in men with severe corporeal fibrosis” by Montague and Angermeier represents a notable contribution to the literature and presents a novel method for managing severe corporal fibrosis that continues to be relevant in contemporary practice. The article is limited by several factors including small patient numbers, relatively short-term follow-up, and an overall lack of relevant details on clinical factors and outcomes. The insufficient operative detail and description of patient selection also significantly hinder the reader from determining the appropriate clinical context for which the procedure would be most applicable. Also, the lack of subsequent follow-up studies or validation by other providers suggests that the relevance of the technique in contemporary practice is unclear. The management of severe corporal fibrosis represents an ongoing surgical challenge, with limited series and lack of comparative, long-term data describing available techniques. As such, the decision as to which surgical technique is most appropriate must be determined based on surgeon experience, severity of fibrosis, and an understanding of potential risks with each therapy. Future management strategies for corporal fibrosis will likely center on prevention through earlier placement of prostheses in cases of refractory ischemic priapism and adoption of salvage techniques in men with infected prosthetics. Corresponding Author: Landon Trost, MD, Department of Urology, Mayo Clinic, 200 First St NW, Rochester, MN 55905, USA. Tel: 507-284-4248; Fax: 507284-4951; E-mail: [email protected] Conflict of Interest: The authors report no conflicts of interest.
Corporal Excavation During Penile Prosthesis Statement of Authorship
Category 1 (a) Conception and Design Landon Trost; Mukul Patil (b) Acquisition of Data Landon Trost; Mukul Patil (c) Analysis and Interpretation of Data Landon Trost; Mukul Patil
Category 2 (a) Drafting the Article Landon Trost; Mukul Patil (b) Revising It for Intellectual Content Landon Trost; Mukul Patil; Andrew Kramer
Category 3 (a) Final Approval of the Completed Article Landon Trost; Mukul Patil; Andrew Kramer References 1 Park JK, Kim HJ, Kang MH, Jeong YB. Implantation of penile prosthesis in a patient with severe corporeal fibrosis induced by cavernosal injection therapy. Int J Impot Res 2002;14: 545–6. 2 Pathak AS, Chang JH, Parekh AR, Aboseif SR. Use of rectus fascia graft for corporeal reconstruction during placement of penile implant. Urology 2005;65:1198–201. 3 Palese MA, Burnett AL. Corporoplasty using pericardium allograft (tutoplast) with complex penile prosthesis surgery. Urology 2001;58:1049–52. 4 Mooreville M, Adrian S, Delk JR 2nd, Wilson SK. Implantation of inflatable penile prosthesis in patients with severe corporeal fibrosis: Introduction of a new penile cavernotome. J Urol 1999;162:2054–7. 5 Rajpurkar A, Li H, Dhabuwala CB. Penile implant success in patients with corporal fibrosis using multiple incisions and minimal scar tissue excision. Urology 1999;54:145–7. 6 Ghanem H, Ghazy S, El-Meliegy A. Corporeal counter incisions: A simplified approach to penile prosthesis implantation in fibrotic cases. Int J Impot Res 2000;12:153–6. 7 Herschorn S, Ordorica RC. Penile prosthesis insertion with corporeal reconstruction with synthetic vascular graft material. J Urol 1995;154:80–4. 8 Montague DK, Angermeier KW. Corporeal excavation: New technique for penile prosthesis implantation in men with severe corporeal fibrosis. Urology 2006;67:1072–5. 9 Fishman IJ. Corporeal reconstruction procedures for complicated penile implants. Urol Clin North Am 1989;16:73–90. 10 Fishman IJ. Complicated implantations of inflatable penile prostheses. Urol Clin North Am 1987;14:217–39.
447 11 Sansalone S, Garaffa G, Djinovic R, et al. Simultaneous total corporal reconstruction and implantation of a penile prosthesis in patients with erectile dysfunction and severe fibrosis of the corpora cavernosa. J Sex Med 2012;9:1937–44. 12 Lopes EJ, Kuwano AY, Guimaraes AN, Flores JP, Jacobino MA. Corporoplasty using bovine pericardium grafts in complex penile prosthesis implantation surgery. Int Braz J Urol 2009;35:49–53, discussion 53–5. 13 Lopes EJ, Santos TC, Jacobino M. Bovine pericardium in penile prosthesis reimplantation. Int Braz J Urol 2007;33: 74–6. 14 Brusky JP, Tran VQ, Rieder JM, Aboseif SR. A preliminary report on combined penoscrotal and perineal approach for placement of penile prosthesis with corporal fibrosis. Adv Urol 2008:524392. 15 Shaeer O, Shaeer A. Corporoscopic excavation of the fibrosed corpora cavernosa for penile prosethesis implantation: Optical corporotomy and trans-corporeal resection, Shaeer’s technique. J Sex Med 2007;4:218–25. 16 Shaeer O. Implantation of penile prosthesis in cases of corporeal fibrosis: Modified Shaeer’s excavation technique. J Sex Med 2008;5:2470–6. 17 Tran VQ, Lesser TF, Kim DH, Aboseif SR. Penile corporeal reconstruction during difficult placement of a penile prosthesis. Adv Urol 2008:370947. 18 George VK, Shah GS, Mills R, Dhabuwala CB. The management of extensive penile fibrosis: A new technique of “minimal scar-tissue excision”. Br J Urol 1996;77:282–4. 19 Knoll LD, Furlow WL, Benson RC Jr, Bilhartz DL. Management of nondilatable cavernous fibrosis with the use of a downsized inflatable penile prosthesis. J Urol 1995;153:366–7. 20 Knoll LD, Furlow WL. Corporeal reconstruction and prosthetic implantation for impotence associated with nondilatable corporeal cavernosal fibrosis. Acta Urol Belg 1992;60: 15–25. 21 Rossello Barbara M, Carrion H. Cavernotomy. Arch Esp Urol 1991;44:185–6. 22 Wilson SK, Delk JR 2nd, Mulcahy JJ, Cleves M, Salem EA. Upsizing of inflatable penile implant cylinders in patients with corporal fibrosis. J Sex Med 2006;3:736–42. 23 Mulcahy JJ. Editorial comment. J Urol 1999;162:2057. 24 Zacharakis E, Garaffa G, Raheem AA, Christopher AN, Muneer A, Ralph DJ. Penile prosthesis insertion in patients with refractory ischaemic priapism: Early vs. delayed implantation. BJU Int 2014;114:576–81. 25 Tausch TJ, Zhao LC, Morey AF, et al. Malleable penile prosthesis is a cost-effective treatment for refractory ischemic priapism. J Sex Med 2015;12:824–6. 26 Ralph DJ, Garaffa G, Muneer A, et al. The immediate insertion of a penile prosthesis for acute ischaemic priapism. Eur Urol 2009;56:1033–8. 27 Salonia A, Eardley I, Giuliano F, et al. European Association of Urology guidelines on priapism. Eur Urol 2014;65:480–9. 28 Swords K, Martinez DR, Lockhart JL, Carrion R. A preliminary report on the usage of an intracorporal antibiotic cast with synthetic high purity CaSO4 for the treatment of infected penile implant. J Sex Med 2013;10:1162–9.
J Sex Med 2015;12(suppl 7):439–447
SUPPLEMENT ARTICLE Critical Appraisal and Review of Management Strategies for Severe Fibrosis During Penile Implant Surgery Landon Trost, MD,* Mukul Patil, MD,† and Andrew Kramer, MD‡ *Department of Urology, Mayo Clinic, Rochester, MN, USA; †Department of Urology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA; ‡Department of Urology, University of Maryland, Baltimore, MD, USA DOI: 10.1111/jsm.12985
ABSTRACT
Introduction. Penile corporal fibrosis represents a challenging clinical scenario for surgeons placing penile prostheses (PP). Because of its rarity, a small number of series with limited follow-up have reported outcomes in this cohort. Aim. The aim of this study was to perform a critical appraisal of the corporal excavation technique, discuss its relevance to contemporary practice, and review alternative surgical methods and outcomes. Methods. A critical review was performed of the 2006 article by Montague and Angermeier, “Corporeal excavation: new technique for penile prosthesis implantation in men with severe corporeal fibrosis.” Notable inclusions and omissions were described, with emphasis placed on methodology and outcomes. A PubMed search from 1990 to June 2015 was then performed to review and summarize the literature on managing corporal fibrosis during PP surgery. Main Outcome Measures. The main outcome measures used were the major contributions and limitations of the 2006 article describing outcomes of the corporal excavation technique. Results. Corporal excavation is a relevant surgical technique for managing severe corporal fibrosis. Compared with alternatives, excavation achieves successful placement of PP without need for grafting and with few complications. The article was limited by several notable omissions including relevant patient demographic and disease characteristics, patient selection, and minimal descriptions of complications and outcomes. Alternative techniques include use of specialized dilators, counter incisions, reconstruction with graft placement, minimal scar tissue excision, and endoscopic resection. Because of limited data, no specific algorithm for managing corporal fibrosis can be prescribed. Conclusions. Corporal fibrosis is a challenging clinical scenario and requires surgical experience and specialized techniques to manage appropriately. Corporal excavation represents one of several viable techniques, which may be chosen based on surgeon’s preference and clinical factors. Trost Landon, Patil Mukul, and Kramer Andrew. Critical appraisal and review of management strategies for severe fibrosis during penile implant surgery. J Sex Med 2015;12(suppl 7):439–447. Key Words. Revision; Salvage; Erectile Dysfunction; Peyronie’s Disease
Introduction
P
enile corporal fibrosis encountered at the time of penile prosthesis (PP) implantation remains a challenging clinical scenario for prosthetic surgeons. Several etiologies may result in corporal fibrosis including long-standing erectile dysfunction (ED), Peyronie’s disease (PD), and diabetes mellitus, among others. The extent of fibrosis
© 2015 International Society for Sexual Medicine
encountered with these conditions is variable and often does not significantly impact surgical placement of PP. In other cases, particularly among patients with prior ischemic priapism or device explantation secondary to infection, fibrosis may be much more severe and limit the extent of dissection performed. Although these cases represent a relatively small percentage of implants overall, they may be associated with higher rates of intraJ Sex Med 2015;12(suppl 7):439–447
440 operative and postoperative complications, including perforations, crossovers, procedural abortions, supersonic transporter (SST) deformities, or infections. Therefore, descriptions of novel surgical techniques, which permit placement of PP while limiting adverse effects, are welcome additions to contemporary prosthetic surgery. Historically, several techniques preceded this first case series studying corporal excavation as a viable surgical option for the management of severe fibrosis. These included the use of synthetic, autologous, or xenografts, cavernotomes, electrovaporization of fibrotic tissue, corporal counter incisions, extended corporotomy, or multiple incisions with minimal scar tissue excision [1–7]. Each of these techniques exhibited varying limitations and side effect profiles. Cavernotomes were appropriate in cases where an initial channel for dilation could be established; however, their use was limited in cases of complete corporal occlusion and by the indirect nature of incisions performed. Counter incisions and minimal tissue excision permitted device implantation in even the most severely occluded corpora; however, adjunctive use of graft materials is frequently required to achieve coverage of the implant cylinders. These techniques were also associated with complications including perforation, infections, and inadequate dilation, support, and positioning of cylinders.
Trost et al.
Results of corporal tissue excavation Limited demographic information was available on the nine patients reported. Etiologies for the fibrosis included four with prior ischemic priapism, four with prior infected PPs, and one with diabetes mellitus and renal transplantation. Information was obtained via retrospective review of charts and patient telephone interviews. At a mean follow-up of 44 months (range 15–92), all patients continued to have a functional prosthetic, with one patient requiring revision for a malfunctioning device at 46 months. Seven patients required reduced diameter devices (AMS 700 CXM™), while two received standard sizes (AMS 700 CX™). Mean length of excised fibrotic corporal segments was 5.2 cm (range 4–7), and mean PP cylinder length was 13.8 cm (range 12–16). No patient required grafting, and all patients reported limited thrusting with intercourse, presumably due to inadequate functional penile length. The authors concluded that the current series supported the use of extensive corporotomies with tissue excavation in cases of severe corporal fibrosis. Suggested benefits over prior techniques included direct visualization and controlled excision of affected tissue without need for grafting. Aims
Description of corporal tissue excavation technique In this setting, Montague and colleagues presented a series of nine patients undergoing extensive corporotomy with corporal excavation at the time of PP implantation [8]. The technique was performed via a penoscrotal, ventral, inverted-T penile incision. This permitted complete exposure of the corpora bilaterally. Ventral corporotomies were subsequently made from the penoscrotal junction to the distal-most extent of the corpora. Metzenbaum scissors were next used to create a plane between the scarred corporal tissue and the tunica albuginea. This was carried circumferentially until a penrose drain could be placed to further assist with the dissection. The scarred fibrotic corporal tissue was then excised as distally as possible to provide a cavity for the PP (AMS, Boston Scientific, Marlborough, MA, USA; 700 inflatable PP [IPP]). Measurements were then obtained, and an appropriately sized device placed. The corpora were subsequently closed using preplaced horizontal mattress sutures. J Sex Med 2015;12(suppl 7):439–447
The original article by Montague and Angermeier presented several notable contributions, which are described in subsequent sections of the current review in greater detail. As with all articles, however, there were several relevant limitations and omissions, which may have improved the overall relevance and quality of the report. The objective of the current article was to critically review the original publication by Montague and Angermeier to evaluate notable omissions or errors which may have had an impact on the data or limit utility by subsequent readers. Each of the issues identified are organized by article section and are not rated or categorized for overall significance. Methods
A critical review was performed of “Corporeal excavation: new technique for penile prosthesis implantation in men with severe corporeal fibrosis” [8]. The report was analyzed for appropriate-
Corporal Excavation During Penile Prosthesis ness of title, methodology, description of the cohort, technique, and outcomes. All sections of the article were reviewed including the title, body text, images, and references. Style issues including the choice of references, narrative, discussion points, and location of material into various sections were not critically evaluated, as these were not felt to have a substantive impact on the overall relevance and quality of the article. To review the literature on corporal fibrosis, a PubMed search was performed of all publications reporting outcomes of techniques for placement of penile prostheses in men with corporal fibrosis. Given the relative paucity of literature in this area, all publications were initially included for review. Detailed analysis and reporting was not performed of all publications reporting outcomes of synthetic grafting materials, given their lack of relevance in contemporary practice. Main Outcome Measures
The primary outcomes included methodological and reporting factors which limited or reduced the quality and reliability of the article. Given the nature of the current publication, these were subjectively determined by the reviewers and did not rely on any objective measures. The secondary outcomes included a thorough review of the current literature on alternative techniques for managing corporal fibrosis. Emphasis was placed on how corporeal excavation fits within the literature as a whole and within current clinical practice. Results
The article title suggests that the technique is a novel procedure being described. However, as noted by the authors in the commentary section, the procedure had previously been reported nearly 20 years earlier [9,10]. The article may therefore be more accurately titled a report on outcomes of the corporal excavation technique with credit for the technique referenced in the introductory sections. The current article only minimally describes patient demographics and disease characteristics. Pertinent missing information includes patient ages, concomitant fibrosing conditions (such as PD), comorbidities, number of prior prosthetics, and time since the most recent explant or episode of priapism. The cohort itself also only represents a small group of patients. Most case reports in
441 contemporary literature require at least 10 cases to be considered for publication. However, given the relative rarity of severe corporal fibrosis necessitating gross excision, a smaller cohort is to be expected. Additional details regarding patient follow-up are notably absent. The number of patients being evaluated in the clinic versus those undergoing telephone follow-up should be indicated, with the date of last clinical follow-up and physical examination reported. Device issues relating to surgery including cylinder herniation or aneurysms, penile angulation, SST deformity, and discrepant distal positioning, among others would not have been identified with telephone interviews alone. Other missing data include the time period during which the procedures were performed and the total number of revision, salvage, and primary prostheses. These data would help to better contextualize the severity of disease represented by the cohort. If the patients included only a small percentage of all revision cases, this would suggest that they were a highly select group with severe disease. In contrast, if the cohort consisted of all salvage cases performed, it would suggest that the patients included those with lesser degrees of fibrosis, given that a large percentage of salvage cases can be appropriately managed with more conservative techniques. Another relevant issue with the study methodology involves patient selection. The authors did not discuss any inclusion or exclusion criteria. It is unclear if any alternative techniques were attempted prior to performing the excavation or if the authors utilized an algorithm for escalating intra-operative dissection. If other techniques were used, it would be helpful to know with what frequency these are performed successfully, and what percentage of patients will ultimately require a more extensive dissection. These missing data are particularly important given that the decisions as to when and on whom to perform a novel technique are equally as important as understanding the technique itself. The description of the surgical technique does not include any information on preoperative antibiotic protocols or methods used to reduce infection. Given the high-risk nature of salvage procedures in general, these data are relevant and help to compare outcomes against alternative techniques. Postoperative instructions, restrictions, and timing of device activation are also notably absent. As these factors are important in J Sex Med 2015;12(suppl 7):439–447
442 optimizing prosthetic outcomes, the lack of information may prevent others from reproducing and validating the findings. Limited discussion is also present on intraoperative management of the proximal corpora. It is expected that scarring in the proximal corpora was as significant as the distal corpora, which is supported by the finding that 7/9 patients required device downsizing for appropriate placement. It is unclear, however, if any corporal excavation was performed of the proximal corpora, or if any specific complications occurred during dilation. Several important findings are notably absent from the current article. Missing intra-operative data include total operative time, rate and extent of discrepant corporal lengths, presence of unilateral versus bilateral corporal excavations, and sidespecific lengths of resected cores. Complication rates are also significantly important in reporting outcomes of a novel surgical technique. Particularly with salvage PP cases, the rate or lack of proximal perforations, crossovers, and number of procedures attempted but aborted should be reported. Given the extent of dissection performed, the rate of wound breakdown, dehiscences, or other similar issues should be indicated. The current report is also very limited regarding patient and partner satisfaction outcomes. The authors note that “some” patients were unable to have penetrative intercourse with select positions, but fail to indicate how many patients this represents. Similarly, the report that all patients were only able to participate in “limited thrusting” should be better detailed. Terminology from nonvalidated subjective questions should be reported so as to better understand potential confounding issues with wording or interpretation. Several statements in the discussion are also unsupportable from the data provided within the article or would require references to support. The report that the current technique results in fewer medial/lateral perforations compared with dilatation techniques cannot be concluded based on the current findings. The authors did not present any data on other techniques, and therefore, no direct comparisons can be drawn. Also, data reported from other series of alternative techniques were not reviewed, further limiting any direct comparisons. See Table 1 for a review of alternative techniques for managing corporal fibrosis. Similarly, the statement that total cylinder length decreased is unsupportable without any data presented on prosthetic sizes with prior implantations. J Sex Med 2015;12(suppl 7):439–447
Trost et al. Another important factor not adequately discussed in the current article is why limited excision occurred despite a complete ventral corporotomy. With excavated tissue ranging between 4 and 7 cm, it is likely that subtotal excavation was achieved. Thus, the entire length of corporal tissue is not excised, nor did the authors address management of the remaining tissue. Similarly, only two of the nine patients were able to receive standard-sized devices, again suggesting significant limitations with corporal excavation as a technique. Readers are left to question how this approach is significantly different from the previously described multiple incision/minimal excision technique [5]? The logical question one might ask, is what is to be gained by excising just a segment or core of fibrotic tissue, and then placing the rest of the device through and around the scarred corpora as is well described in many other situations? The most treacherous issues for cylinder placement would be the most proximal and distal extents of the corpora, since these are further from the open incision and require potentially risky dilatation techniques. This approach leaves the scarred corpora in these dangerous locations, and only removes it in the safest area, the part closest to the incision. Surgeons have progressed toward less intrusive corporal access, going as far for some to exclude sequential dilatation or even any dilatation at all. Leaving some of the natural tissues behind may be thought to spare some of the blood supply, for healing, infection control, and ease of recovery. This technique seems to walk back a few steps in the spectrum of invasiveness, offering the most extreme approach.
Review of management techniques for corporal fibrosis Corporal fibrosis remains a significant challenge for the prosthetic surgeon in contemporary practice. Despite over 30 years of surgical technique development, the optimal strategy and surgical procedure has not been identified. See Table 1 for a summary of various techniques with reported outcomes. Corporal fibrosis represents a heterogeneous condition. Fibrosis may involve small or large segments of the corpora and may result in significant reductions in luminal diameter in many cases. The severity of fibrosis also varies significantly and ranges from minimal scarring to complete occlusion of the corpora. Optimal strategies to identify patients at high risk for corporal fibrosis have not
2006 (9)
Montague [8]
1996 (12)
1995 (20) 1995 (11)
George [18]
Knoll [19]
Cavernotomes
Grafting
Grafting
Downsized prosthesis
Grafting
Cavernotomes
Multiple incisions, minimal scar excision
Counter incisions
Grafting
44
48
58
56
60
56
38
58
46
20
22
24
10
12
18
44
1–12
91
32
26
PTFE—92%
None
PTFE—38%
Cadaveric pericardium— 100% None
None
Rectus fascia—100%
None
Rectus fascia—66% None—33% None
AMS 700CX—82% Jonas-9.5 mm—18%
PTFE—100%
PTFE—100%
Infection—90% Priapism—10% Explant—27% Infection—36% Priapism—18%
Infection—83% Priapism—17%
Infection—81% Priapism—19%
ICI—6% Infection—82% Priapism—12%
Infection—71% Priapism—29%
Erosion—100%
ICI—17% Infection—42% Priapism—33% Unknown—8% DM + Tx—11% Infection—44% Priapism—44% PD—47% Erosion—27% Explant—7% Infection—20% Priapism—100%
Infection—100%
Crossover—19% Crural perforation—38% Distal perforation—25% Infection—0% Malfunction—8% Revision—25% Infection—5% Revision—5% Infection—0% Malfunction—0% Revision—27% Infection—30%
Crural perforation—6% Infection—0% Revision—0% Crural perforation—3% Infection—0% Malfunction—3% Revision—12%
Complications—0%
Infection—0% Penile hypoesthesia—14% Satisfaction—100%
Malfunction—11%
Complications—0% Revisions—0% Complications—0%
Elective revision—22% Satisfied—71% Satisfied—100%
Etiology for fibrosis Outcomes
Porcine dermis—61% Infection—100% Collagen dermis—39% Bovine pericardium—100% Priapsim—60% Infection—40%
Graft
Downsized (dilated to 10 mm)—100% None
Duraphase-10 mm—41% Malleable-9.5 mm—47% Malleable-11 mm—12% Alpha-1—44% AMS 600—21% AMS 700—21% Semirigid—12% Mark-2—3% Alpha-1—13% Alpha-NB—75% AMS 700CXM—13% Semirigid—58% Inflatable—42%
Mentor-NB—100%
Alpha-1—47% AMS 700—53% - Unclear if reduced cylinder size
AMS 700CXM—78% AMS 700CX—22%
Standard inflatable—33% Malleable 13 mm—66%
Malleable
AMS 700CX—78% AMS 650 11 mm—22%
Mean Mean F/U age (mo) Device
*Data from 2008 study summarized; **Publication in 2008 with identical data; DM + Tx = diabetes mellitus and renal transplantation; F/U = follow-up; ICI = intracavernosal injection therapy; PD = peyronie’s disease; PTFE = polytetrafluoroethylene.
Rossello Barbara [21]
Knoll [20]
1992 (30) 1991
1999 (16)
Mooreville [4]
Herschorn [7]
1999 (34)
Rajpurkar [5]
Ghanem [6]
Palese [3]
Open resectoscope
Park [1]
2002 (1) 2001 (4) 2000 (17)
Grafting
Corporal excavation
Penoscrotal/perineal approach Ultrasound guided endoscopic resection
Grafting
Excavation with grafting
Technique
**Pathak [2,17] 2005 (15)
Shaeer [15,16]
Brusky [14]
Lopes [12,13]
2012 (18) 2009 2007 (5) 2008 (3) 2008* 2007 (12)
Year (n)
Outcomes of techniques to manage penile fibrosis during penile prosthesis implantation
Sansalone [11]
Author
Table 1
Corporal Excavation During Penile Prosthesis 443
J Sex Med 2015;12(suppl 7):439–447
444 been described. Anecdotally, and based on prior descriptions of cohorts, cases of prior penile infection with device removal and ischemic priapism represent some of the conditions more likely to result in severe fibrosis [6,8,12]. However, even in these settings, significant portions of nonfibrotic tissue may be encountered. Multiple techniques have been described to manage corporal fibrosis at the time of device implantation. Initial techniques primarily utilized direct incisions into the scarred tissue with or without graft placement [7,18,20]. Although this permitted device placement in the majority of cases, it frequently was time consuming and included the use of synthetic graft materials, which subsequently fell out of favor due to high revision and infection rates. Later descriptions of autologous, xenologous or cadaveric allografts demonstrated successful placements in all patients, with many able to receive standard-sized implants primarily [2,3,11,12,14]. Revisions range from 0% to 22% and satisfaction 71% to 100% at follow-ups of 10–91 months. To address some of the limitations with early synthetic grafting materials, specialized cavernotomes were developed. Rossello Barbara and Carrion initially reported on the use of a grooved dilator (Carrion-Rossello) to assist with corporal dissection [21]. The instrument was carefully introduced into the scarred tissue with rotating motions (similar to the action used with a wood rasp in carving) to create a channel for the PP. Mooreville and colleagues similarly introduced a modified cavernotome (Uramix/Mooreville) used in a rotating fashion to incise and abrade tissue in 1 mm increments. Although the devices enhanced available options for managing corporal fibrosis, they were best suited for cases in which an initial tract could be established and were ultimately less successful in creating initial tracts for dissection. Outcomes with the Mooreville dilator demonstrated reduced operative time and successful placement in 16 patients without need for grafting. However, only two patients were able to receive standard-sized implants, and complications included 38% proximal and 25% distal perforations (delayed recognition) [4]. The introduction of narrow-base prosthetic models (AMS 700 CXM™ 1990, Alpha 1 NB / Titan NB®, Humlebaek, Denmark, 2002) further increased options for managing severe proximal corporal fibrosis. In contrast to standard size cylinders, which require proximal dilation to a minimum of 12 mm, downsized cylinders may be placed in J Sex Med 2015;12(suppl 7):439–447
Trost et al. cases where only 10 mm of dilation is achieved. Initial outcomes from a series of 20 patients receiving downsized cylinder placement (AMS 700 CXM™) demonstrated a 5% infection rate, with 95% prosthetics functioning at a mean 20 months follow-up [19]. Although some patients will elect to continue with the down-sized devices, Wilson and colleagues reported the feasibility of subsequent device upsizing in a report of 37 men who successfully were converted to standard cylinders after 1 year with the smaller devices. In addition to cylinder diameter upsizing, results also demonstrated a mean 2.2 cm increase in overall implant length without reported complications [22]. Another notable, although preliminary, contribution to the management of corporal fibrosis includes use of a minimally invasive endoscopic approach. The proof of concept for the technique was initially introduced by Park and colleagues who used a resectoscope loop to dissect out scarred cavernosal tissue in one patient via direct cut-down access [1]. Shaeer and colleagues subsequently advanced the technique using a minimally invasive, endoscopic approach [15,16]. Resection of fibrotic tissue was performed under direct vision in a methodical and controlled process. In cases where an initial channel was unable to be developed, the Otis urethrotome (previously described by Mulcahy) and/or ultrasound-guided placement of a guidewire were used to assist in localization and limit complications [16,23]. Results from 12 patients undergoing the procedure at 1–12 months follow-up demonstrated no complications with successful placement of standard-sized devices in all patients without need for grafting. Given the preliminary nature of the report and lack of subsequent validation or follow-up, further study is required of this technique prior to routine implementation. The description of corporal excavation introduced several enhancements over earlier techniques. Compared with grafting, corporal excavation offered similar outcomes while maintaining the rigidity and structure of the native tunical tissue. Unfortunately, because of limited data presented in many grafting series, it is unclear if grafting is able to consistently achieve a significantly higher percentage of standard diameter cylinders compared with excavation alone. Corporal excavation also provided an alternative to cavernotomes, which were associated with higher rates of recognized and unrecognized corporal perforations and often required placement of smaller diameter cylinders [4]. When compared
445
Corporal Excavation During Penile Prosthesis Table 2 Advantages and disadvantages of techniques for managing severe corporal fibrosis at the time of penile prosthesis implantation Advantages
Disadvantages
Corporal counter incisions Corporal excavation
• Reduces need for graft placement • Able to dissect under direct vision • Reduces likelihood for unrecognized injury
Corporal reconstruction (Grafting)
• Able to dissect under direct vision • Reduces likelihood for unrecognized injury • Permits placement of standard-sized cylinders
Specialized dilators (CarrionRossello; Uramix/Mooreville)
• Reduced operative time • Additional corporotomies/extended incision not required • Can be combined with counter incision technique to reduce likelihood for complications • Minimally invasive • Permits placement of standard-sized cylinders
• Requires extensive corporotomy (excavation; not counter incision) • Lack of externally validating series • Frequently requires downsized cylinders • Requires graft placement • Likely increased operative time • Durability of graft and overall repair unknown (extrusions, cylinder aneurysms) • Risk of recognized and unrecognized perforations • Requires specialized instruments • Often requires reduced diameter cylinders
Endoscopic electrocautery resection
with the counter incision technique, similar benefits are achieved regarding reduced corporal perforations and avoidance of graft materials, with relatively similar rates of downsized cylinders required [6]. See Table 2 for a summary of advantages and disadvantages with various corporal fibrosis management strategies.
Contemporary role for corporal excavation The current role for complete corporal excavation is debatable. Since the original publication, longterm follow-up and externally validated series have not been reported. In view of the larger number of studies published using reconstruction with various grafting materials (including publications post-dating the description of corporal excavation), this would suggest that grafting is more widely utilized, and generalized adoption of corporal excavation has not occurred. It is unclear if the larger number of series describing the use of grafting materials is due to the relative ease of the technique over excavation or because of other factors. Similarly, subsequent publications describing alternative, minimally invasive techniques for the management of corporal fibrosis (i.e., endoscopic electrocautery dissection) would also suggest that the optimal technique for managing this difficult to treat issue remains elusive [15,16]. Corporal excavation clearly has advantages over alternative techniques, in that it permits placement of cylinders without need for grafting and allows direct dissection with ability to recognize and manage perforations accordingly. However, corporal excavation is also maximally invasive,
• Requires specialized equipment • Ultrasound guided placement of guide wire may require specialized skillsets • Anticipated learning curve • Lack of externally validating series
requires specialized skillsets, is likely overly aggressive in the majority of cases of corporal fibrosis, and has unclear benefits over less invasive techniques such as counter incision and endoscopic electrocautery resection.
Defining an algorithm Given the relative paucity of data, absence of comparative series, and heterogeneous nature of corporal fibrosis, it is not possible to suggest a definitive optimal strategy or algorithm for management. One exception to this is the recommendation to avoid use of synthetic graft materials because of their association with elevated infection rates. Specialized dilators and cavernotomes remain a viable option in select patients, particularly among patients where an initial tract for dissection can be obtained. However, even in this setting, it is unclear if the use of specialized dilators should be considered an optimal first-line approach, particularly given the relatively high rate of recognized and unrecognized complications reported [4]. Although cases where an initial tract is able to be established likely represent less severe underlying fibrosis, it is unclear if specialized dilators are able to achieve better proximal and distal cylinder positioning or improved dilation over standard dilating methods alone. It is also unclear if there are differing complication rates among patients treated with specialized dilators based on the ability to achieve an initial tract or not. In the absence of adequate data, the role for specialized dilators remains unclear. J Sex Med 2015;12(suppl 7):439–447
446 Perhaps corporal excision, or “excavation,” would be one of many tools that a surgeon possesses, although it would only be used in the most desperate situations involving impassable segments of corpora. If a dilating tool or Furlow instrument can bypass a scarred segment, the tissue expanding qualities of the devices would likely expand these difficult regions through cycling alone, rendering excavation largely unnecessary. However, if counter incisions are done, several dilating instruments employed, and there remains absolutely no space for a long length of corpora, then large-scale excavation could be a last ditch option. From an algorithmic standpoint, the role for corporal excavation likely fits with other extreme and seldom used options including grafting and other major penile reconstructions. Given the limitations with each technique, variable advantage/disadvantage profiles, and lack of definitive data, the ultimate decision as to how to proceed in each clinical scenario should remain at the discretion of the surgeon based on experience, comfort level, and clinical factors.
Future strategies Future management of corporal fibrosis will likely center on prevention. Several authors have suggested a role for early placement of PP in men with prolonged ischemic priapism [24–26]. Compared with a delayed approach, early placement is technically easier to perform, has fewer complication rates, and prevents loss of penile length associated with scar tissue contraction [24]. These benefits have also been recognized and are reflected in the most recent European Association of Urology guidelines on priapism [27]. Another strategy currently undergoing evaluation is the use of space holding materials at the time of infected implant removal. Preliminary data on the instillation of calcium phosphate into corpora following device removal suggests that it may provide a viable option to reduce subsequent scarring and facilitate delayed implantation [28]. Longer term data and further validation are required prior to routine implementation. The use of salvage washout techniques to manage infected PP will also further reduce the prevalence of significant corporal fibrosis. Although the optimal antibiotic regimen, washout protocol, and device to be used at the time of salvage surgery are not well defined, additional studies reporting outcomes will further support this J Sex Med 2015;12(suppl 7):439–447
Trost et al. therapy as a standard of care option for managing infected devices. Ongoing advancements in the management of ED will also likely further reduce the prevalence of corporal fibrosis. As novel treatments including shockwave therapy, tissue engineering, and new pharmacotherapies are developed, placement of PP may be delayed until later in life. This, combined with anticipated mechanical advancements and ongoing attempts at infection reduction in PP technology, will likely lead to a reduction in the relative frequency of revision surgeries required. Conclusions
The article “Corporeal excavation: new technique for penile prosthesis implantation in men with severe corporeal fibrosis” by Montague and Angermeier represents a notable contribution to the literature and presents a novel method for managing severe corporal fibrosis that continues to be relevant in contemporary practice. The article is limited by several factors including small patient numbers, relatively short-term follow-up, and an overall lack of relevant details on clinical factors and outcomes. The insufficient operative detail and description of patient selection also significantly hinder the reader from determining the appropriate clinical context for which the procedure would be most applicable. Also, the lack of subsequent follow-up studies or validation by other providers suggests that the relevance of the technique in contemporary practice is unclear. The management of severe corporal fibrosis represents an ongoing surgical challenge, with limited series and lack of comparative, long-term data describing available techniques. As such, the decision as to which surgical technique is most appropriate must be determined based on surgeon experience, severity of fibrosis, and an understanding of potential risks with each therapy. Future management strategies for corporal fibrosis will likely center on prevention through earlier placement of prostheses in cases of refractory ischemic priapism and adoption of salvage techniques in men with infected prosthetics. Corresponding Author: Landon Trost, MD, Department of Urology, Mayo Clinic, 200 First St NW, Rochester, MN 55905, USA. Tel: 507-284-4248; Fax: 507284-4951; E-mail: [email protected] Conflict of Interest: The authors report no conflicts of interest.
Corporal Excavation During Penile Prosthesis Statement of Authorship
Category 1 (a) Conception and Design Landon Trost; Mukul Patil (b) Acquisition of Data Landon Trost; Mukul Patil (c) Analysis and Interpretation of Data Landon Trost; Mukul Patil
Category 2 (a) Drafting the Article Landon Trost; Mukul Patil (b) Revising It for Intellectual Content Landon Trost; Mukul Patil; Andrew Kramer
Category 3 (a) Final Approval of the Completed Article Landon Trost; Mukul Patil; Andrew Kramer References 1 Park JK, Kim HJ, Kang MH, Jeong YB. Implantation of penile prosthesis in a patient with severe corporeal fibrosis induced by cavernosal injection therapy. Int J Impot Res 2002;14: 545–6. 2 Pathak AS, Chang JH, Parekh AR, Aboseif SR. Use of rectus fascia graft for corporeal reconstruction during placement of penile implant. Urology 2005;65:1198–201. 3 Palese MA, Burnett AL. Corporoplasty using pericardium allograft (tutoplast) with complex penile prosthesis surgery. Urology 2001;58:1049–52. 4 Mooreville M, Adrian S, Delk JR 2nd, Wilson SK. Implantation of inflatable penile prosthesis in patients with severe corporeal fibrosis: Introduction of a new penile cavernotome. J Urol 1999;162:2054–7. 5 Rajpurkar A, Li H, Dhabuwala CB. Penile implant success in patients with corporal fibrosis using multiple incisions and minimal scar tissue excision. Urology 1999;54:145–7. 6 Ghanem H, Ghazy S, El-Meliegy A. Corporeal counter incisions: A simplified approach to penile prosthesis implantation in fibrotic cases. Int J Impot Res 2000;12:153–6. 7 Herschorn S, Ordorica RC. Penile prosthesis insertion with corporeal reconstruction with synthetic vascular graft material. J Urol 1995;154:80–4. 8 Montague DK, Angermeier KW. Corporeal excavation: New technique for penile prosthesis implantation in men with severe corporeal fibrosis. Urology 2006;67:1072–5. 9 Fishman IJ. Corporeal reconstruction procedures for complicated penile implants. Urol Clin North Am 1989;16:73–90. 10 Fishman IJ. Complicated implantations of inflatable penile prostheses. Urol Clin North Am 1987;14:217–39.
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