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Simultaneous Total Corporal Reconstruction and Implantation of a Penile Prosthesis in Patients with Erectile Dysfunction and Severe Fibrosis of the Corpora Cavernosa
1
Simultaneous Total Corporal Reconstruction and Implantation of a Penile Prosthesis in Patients with Erectile Dysfunction and Severe Fibrosis of the Corpora Cavernosa jsm_2748
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Salvatore Sansalone, MD,*1 Giulio Garaffa, MD, FRCS (Urol),†1 Rados Djinovic, MD,‡ Gabriele Antonini, MD,§ Giuseppe Vespasiani, MD,* Francesco Pio Ieria, MD,* Sebastiano Cimino, MD,¶ Carla Loreto, MD,** and David J. Ralph, MD† *Department of Urology, School of Medicine Tor Vergata University of Rome, Rome, Italy; †St. Peter’s Andrology, University College London Hospitals, London and Broomfield Hospital, Chelmsford, UK; ‡Department of Urology, School of Medicine, Serbian Academy of Science and Arts, University of Belgrade, Belgrade, Serbia; §Department of Urology, “U.Bracci” University La Sapienza, Rome, Italy; ¶Department of Urology, University of Messina, Messina, Italy; **Department of Bio-Medical Sciences, Anatomy Section, University of Catania, Catania, Italy DOI: 10.1111/j.1743-6109.2012.02748.x
ABSTRACT
Introduction. Implantation of a penile prosthesis in severely scarred corporal bodies represents a great challenge as fibrosis can compromise dilatation and subsequent closure of the corpora cavernosa and limit size, type, and function of the device. Aim. The aim of this study is to report our experience of simultaneous corporeal reconstruction and penile prosthesis implantation in patients with severe penile contracture consequence of diffuse fibrosis. Methods. Between March 2006 and February 2010, 18 patients with severe penile contracture and coporeal fibrosis underwent simultaneous corporeal reconstruction and placement of a penile prosthesis. Main Outcome Measures. Surgical outcome and complications have been recorded during postoperative follow-up. Patients’ satisfaction has been assessed 6 months postoperatively with the administration of the modified Erectile Dysfunction Index of Treatment Satisfaction questionnaire. Results. Although the dilatation of the corpora was extremely difficult due to the severe fibrosis, a penile prosthesis has been implanted in all patients. A malleable penile prosthesis has been inserted in four patients and a three-piece inflatable device in the remainder. After an average follow-up of 26 months (range 6–36), revision surgery was required in four patients (elective exchange to three-piece inflatable device in three patients and upsizing of the implant in one patient). Although all patients were able to achieve penetrative sexual intercourse, four patients were partially dissatisfied because of significant penile shortening. Conclusion. In expert hands, simultaneous penile prosthesis implantation and corporal reconstruction of severely scarred corpora yield satisfactory results. Patients must be warned that complication rate in presence of severe fibrosis is significantly higher than in virgin cases and that downsized cylinders might be required due to the contracture of the tunica albuginea. Sansalone S, Garaffa G, Djinovic R, Antonini G, Vespasiani G, Ieria FP, Cimino S, Loreto C, and Ralph DJ. 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 **;**:**–**. Key Words. Low Flow Priapism; Erectile Dysfunction; Infection; Erosion; Inflatable Penile Prosthesis; Malleable Penile Prosthesis; Graft
1
Both authors have contributed equally to the production of this article.
© 2012 International Society for Sexual Medicine
J Sex Med **;**:**–**
2
Sansalone et al.
Introduction
D
ense corporeal fibrosis (CF) poses a severe challenge to the implanting surgeon as dilatation of the corpora can be extremely difficult. Due to the contracture of the tunica albuginea, downsized cylinders are often required, and a penile shortening of up to 4–6 cm is a common finding [1]. Penile fibrosis usually occurs following explantation of infected penile prosthesis, refractory low flow priapism, severe penile trauma, Peyronie’s disease (PD), and intracavernosal injection of vasoactive drugs [2–4]. Among all these conditions, explantation of an infected penile implant leads to a more significant degree of scarring and contracture, and this group of patients is characterized by a more extensive and dense fibrosis in the crura than in the shaft [5]. Patients with refractory ischemic priapism instead tend to develop severe distal fibrosis with relatively normal crura, and therefore penile prosthesis implantation is relatively easier [6]. Over the years, multiple surgical approaches have been suggested to facilitate penile prosthesis implantation in patients with severe CF. Extensive corporotomies or distal second incisions, excision of the scarred tissue, and the use of the Otis urethrotome, cavernotomes, and resectoscope loops has shown to be useful to create sufficient space to house the cylinders in the vast majority of patients. However, in some cases, the degree of scarring and contracture is so severe that closure of the tunica albuginea over a penile implant is impossible, and therefore reconstruction of the corpora with a patch becomes necessary [1,2,7–14]. This series reports the long-term outcome from patient’s and surgeon’s perspective of simultaneous corporeal reconstruction and penile prosthesis implantation in patients’ severe fibrosis and contracture of the corpora cavernosa.
Methods and Main Outcome Measures
Between March 2006 and February 2010, 18 patients with severe corporeal scarring and penile shortening underwent simultaneous corporeal reconstruction and insertion of a penile prosthesis (Figure 1). All patients had previously undergone implantation of a penile prosthesis and subsequent removal of the infected implant in another institution. Two patients have had a repeated attempt of implantation, but the device was then removed because of infection in one case and erosion in the J Sex Med **;**:**–**
Figure 1 Severe corporeal scarring with penile shortening consequence of explantation of an infected penile prosthesis.
other. Overall, seven patients were diabetics (39%), and the indication for the initial implantation of the erectile device was refractory erectile dysfunction in 12 patients and PD in six patients. Prior to surgery, all patients have been adequately counseled about the potential intraand postoperative complications, including urethral perforation, crossover, corporal injury, penile prosthesis infection, erosion, and mechanical failure. Patients were aware that implantation of a penile prosthesis in severely fibrotic corpora is associated with high complications rate, that the procedure would have been abandoned in case of urethral injury, and that the expected postoperative penile size would not be longer than the preoperative stretched penile length [1]. After adequate counseling about the different types of penile implants, 14 patients opted for a three-piece inflatable device (AMS 700 CX, American Medical Systems, Minnetonka, MN,
Implantation of Prosthesis and Total Corporal Reconstruction USA) and the remainder for a malleable one (AMS 650 11 mm, American Medical Systems). Surgical Technique
All patients underwent implantation of the device after intravenous administration of Gentamicin (Sandoz, Holzkirchen, Germany) and Amoxicillin/ Clavulanic acid (Co-Amoxiclav, GlaxoSmithKline, London, UK) and 10 minutes scrub of the surgical field with povidone-iodine (Betadine, Meda, Sweden). Surgery was carried out through a longitudinal scrotal incision that was extended on the ventral aspect of the shaft up to the corona in order to guarantee adequate exposure of the corpora from the crura to the distal tips. Once a complete exposure of the corpora was achieved, two longitudinal corporotomies, one on each side of the urethra, were carried out from the crura to the coronal sulcus and the scarred cavernosal tissue dissected off the tunica albuginea. This procedure has been carried out with blunt dissection with Metzenbaum scissors. The use of the hand-held diathermy was avoided if possible in order to prevent thermal damage to the neurovascular bundle and consequent postoperative glans numbness (Figure 2). Once the scarred tissue was completely excised, the tunica albuginea was carefully assessed. A total corporeal reconstruction was performed only if the tunica was so severely contracted and inadequate that closure over a 9 mm Hegar could not be accomplished without tension, thus precluding
Figure 2 Once the corpora are exposed through a midline ventral incision, the two corporotomies are extended from the crura to the corporeal tips, and the fibrotic cavernosal tissue is excised with blunt dissection.
3
even the insertion of an AMS 600 or of an AMS CXR (American Medical Systems, Minnetonka, Minnesota, USA). Proximal blunt dissection was carried out carefully under vision with Metzenbaum scissor first and with cavernotomes subsequently. In four patients, proximal fibrosis was so dense that blunt dissection could not be performed safely, and therefore the corporotomies were extended proximally almost to the tip of the crura. In one patient, a proximal perforation was recognized intraoperatively and managed successfully with an anchoring suture in 0 Polydioxanone (PDS II; Ethicon Inc., Somerville, NJ, USA). Under a continuous irrigation of the surgical field with Gentamicin solution, the ventral aspect of the corpora was reconstructed with the use of porcine dermis (InteXen, American Medical Systems) patch graft in 11 patients and acellular collagen dermis (Pelvicol, Bard Medical, Murray Hill, NJ, USA) in the remainder. All sutures have been carried out with 2-0 Polydioxanone in a running fashion (Figure 3). Reconstruction of the corpora has bee carried out over an 11 mm Hegar dilator in patients undergoing implantation of an inflatable device and directly on the rods in patients who have opted for a malleable prosthesis. The inflatable rods were inserted after the reconstruction of the corpora to prevent inadvertent perforation of the cylinders (Figure 4). Insertion of reservoir and pump were carried out in the usual fashion, and after the closure of dartos and skin with running 3-0 polyglactin sutures (Vicryl, Ethicon Inc., Somerville, NJ, USA) (Figure 5), a light compressive dressing was applied to shaft and scrotum to reduce the risk of edema and hematoma formation. A 12-French suction drain was left postoperatively in the scrotum in all patients, and the cylinders of the AMS 700 CX were left semi-inflated. Patients were discharged home with 2 weeks of oral Amoxicillin/Clavulanic acid (Co-Amoxiclav, GlaxoSmithKline) on postoperative day one after the removal of compressive dressing and drain and, in case of implantation of an inflatable device, once the prosthesis were successfully deflated. Postoperative follow-up was started 4–6 weeks postoperatively, and patients who have had a three-piece inflatable penile prosthesis implanted were encouraged to cycle the device on a daily basis to prevent further scar formation around the cylinders, as this might have led to further shortening or deformity. Sexual activity was encouraged once the skin wounds were completely healed, and J Sex Med **;**:**–**
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Sansalone et al. A
B
C
Figure 3 The ventral aspect of the corpora is reconstructed with a Pelvicol patch and running 2-0 Polydioxanone sutures. (A) In patients undergoing implantation of an inflatable device, reconstruction is performed over an 11-cm Hegar dilator in order to prevent inadvertent perforation of the cylinders. (B) The reconstruction is started at the level of the tips and continued proximally to the base of the penis. (C) In case of implantation of a semirigid rod, the reconstruction is carried out directly over the cylinders.
the patient was comfortable with inflating and deflating the device. Surgical outcome and postoperative complications were recorded in the postoperative follow-up that was scheduled at 6 months and every year thereafter. Patients’ satisfaction was assessed at the 6 months postoperative follow-up visit with the administration of the modified Erectile Dysfunction Index of Treatment Satisfaction (EDITS) questionnaire [15–17]. Surgical outcome and patients’ satisfaction were then assessed subjectively by the surgeon in the subsequent visits. Results
The average age at the time of surgery was 58 years (range 46–65 years), and the mean time from J Sex Med **;**:**–**
the explantation of the previous device was 14 months (range 7–18). When comparing the size of the implanted cylinders with the one of the previously explanted rods, the average loss of length was 3 cm (range 2–4.5). Overall, postoperative complications consisted in superficial scrotal wound dehiscence and a small scrotal hematoma, respectively, in two and three patients and were managed conservatively with the prolonged administration of broad spectrum antibiotics. Revision surgery was required in four patients (22%); the indications were elective exchange of an AMS 650 to an AMS 700 CX in three patients and to upsize an inflatable implant in one patient. The average increase of length in patients who have undergone elective exchange of a malleable device to a three-piece inflatable was 2 cm (range
Implantation of Prosthesis and Total Corporal Reconstruction
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A
B
Figure 4 The reconstructed corpora after the implantation of the cylinders. (A) The cylinders of AMS 700 CX are comfortably housed into the reconstructed corpora. (B) The reconstruction after implantation of the AMS 650 11 mm malleable penile prosthesis.
1–3.5) while a gain of 3 cm was achieved after upsizing of the device. After an average follow-up of 26 months (range 6–36), the prosthesis was sitting in the correct position, and the penis was reasonably straight and rigid enough to guarantee successful sexual penetration in all cases; all patients who have undergone implantation of a three-piece inflatable penile prosthesis were able to cycle the device. Overall, 14 patients returned the modified EDITS questionnaire at the 6 monthly postoperative review, and the results are shown in Table 1. Overall, 10 patients (71%) were fully satisfied with the cosmetic and functional result of surgery. Although no patient complained of postoperative shortening, four patients were not satisfied with penile length. Discussion Figure 5 The final result after implantation of the AMS 650 and closure of Dartos and skin with 3-0 Vicryl sutures.
Penile prosthesis implantation in patients with severe fibrosis of the corpora cavernosa still repreJ Sex Med **;**:**–**
6 Table 1
Sansalone et al. Patients’ satisfaction 6 months postoperatively
Domain
Outcome measure(s)
Overall satisfaction (domain #1)
Satisfied (1 and 2) 10 (71%) Halfway (3) 20 Somewhat dissatisfied (4 and 5) 4 (29%)
Overall confidence (domain #4)
Confident (1 and 2) 10 (71%) Halfway (3) 0 Somewhat dissatisfied (4 and 5) 4 (29%)
Postoperative penile Satisfied (1 and 2) length (domain #9) Halfway (3) Dissatisfied (4 and 5)
Outcome
10 (71%) 0 4 (29%)
sents a challenge and is associated with low levels of patients’ satisfaction because of penile shortening and elevated rate of intra- and postoperative complications [1–14]. Although extremely difficult, dilatation of severely fibrotic corpora can be achieved with complete exposure of the corpora cavernosa, extended or multiple corporotomies, and the use of cavernotomes, Otis urethrotomes, and resection loops. However, patients with associated severe contracture of the tunica albuginea and penile inadequacy still represent a surgical dilemma as the simple dilatation of the corpora cavernosa, if feasible, would not create enough space to house downsized cylinders. Therefore, traditionally, this group has been managed with total phallic reconstruction with the use of infraumbilical, groin, or free flaps [18]. Although total phallic reconstruction with the use of the radial artery-based forearm free flap guarantees excellent cosmetic and functional results and represents the best technique available at the moment [19], patients are always better served if their penis is preserved. Therefore, simultaneous corporeal reconstruction and penile prosthesis implantation should be always attempted in patients with penile inadequacy as a consequence of CF and albuginea scarring. Although the use of patch grafts to cover limited tunical defects after the implantation of a penile prosthesis in patients with severe fibrosis has been already described, this is the largest series
Table 2 fibrosis
of simultaneous total corporeal reconstruction and insertion of erectile devices reported so far (Table 2) [20–24]. This series confirms that satisfaction rates in patients undergoing penile prosthesis implantation in severely scarred corpora tend to be low [1,4,7,8]. Moreover, the fact that after a median follow-up of 26 months that no case of mechanical failure has been recorded suggests that there has been a significant improvement in the reliability of the inflatable penile implants when compared with previous data [1,8]. The use of grafts has been very popular after the excision of the fibrotic tissue when the tunica albuginea does not allow closure of the corpora cavernosa. In fact, defects in the tunica albuginea larger than 1 cm, if left not covered, are associated with increased risk of aneurysmal dilatation of the cylinders, erosion, migration, infection, and mechanical failure of the device [2,25,26]. Graft materials can be classified in three categories: synthetic, autologous tissue, and extracellular matrix. The most common synthetic grafts are Goretex (Polytetrafluoroethylene, Gore Medical, Flagstaff, Arizona, USA) and Dacron (Polyethylene terephthate, Gore Medical, Flagstaff, Arizona, USA), while the most common autologous materials used in prosthetic surgery are saphenous vein, dermis, buccal mucosa, rectus fascia, and fascia lata. Bovine and cadaveric pericardium, porcine small intestine submucosa, and cadaveric fascia lata represent instead the extracellular matrix grafts [27]. Each graft in material has its own advantages and drawbacks in terms of availability, antigenicity, and cost effectiveness. The main disadvantage of synthetic grafts is their immunogenicity, which translates in a significantly increased penile prosthesis infection rate, which has been reported as high as 30%, while donor size morbidity, limited availability, and increased operative time are the downsides of autologous materials [28]. Extracellular matrix grafts instead are not associated with donor site morbidity and limited avail-
Series describing the use of patch grafts for complete corporeal reconstruction in patients with severe corporeal
Author
Year
No. of patients
Graft material
Complications
Follow-up*
Tran et al. and Patak et al. [11,23] Lopes et al. [24]
2008 2007
8 1
Rectus fascia Pericardium
0 0
18 24
*Follow-up in months
J Sex Med **;**:**–**
Implantation of Prosthesis and Total Corporal Reconstruction ability and according to various authors are not associated with increased infection rates of the prosthetic device, although larger series will be necessary to confirm these data [17,21]. Therefore, extracellular matrix grafts represent the material of choice when grafting is required. Although no patient developed penile prosthesis infection and ultimately required explantation of the device, grafts should be avoided when possible in penile prosthetic surgery [7]. In this series, the only indication for corporeal reconstruction with the use of grafts was severe contracture and insufficiency of the tunica albuginea that would have precluded closure over an AMS 600 or an AMS CXR. When possible, patients are better served without the use of grafts even at the expense of using a downsized implants as with regular cycling and use, the device acts as a tissue expander and many of these patients will be able to undergo replacement of the downsized cylinders with standard diameter, longer cylinders [1,2,7]. Conclusion
This series confirms that in expert hands, total corporeal reconstruction is a safe and reliable technique in patients with penile inadequacy consequence of severe corporeal scarring and albugineal contracture. Because patients’ satisfaction rates are low because of unrealistic expectations, an adequate and thorough preoperative counseling is necessary. Corresponding Author: Salvatore Sansalone, MD, Policlinico di Tor Vergata, University of Rome, Viale Oxford 81, Rome 00133, Italy. Tel: +393471792019; Fax: +390620902975; E-mail: salvatore.sansalone@ yahoo.it Conflict of Interest: None. Statement of Authorship
Category 1 (a) Conception and Design Salvatore Sansalone; Giulio Garaffa; Rados Djinovic; Gabriele Antonini; Giuseppe Vespasiani; Francesco Pio Ieria; Sebastiano Cimino; Carla Loreto (b) Acquisition of Data Salvatore Sansalone (c) Analysis and Interpretation of Data Giulio Garaffa
Category 2 (a) Drafting the Article Giulio Garaffa
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(b) Revising It for Intellectual Content Giulio Garaffa; David J. Ralph; Salvatore Sansalone
Category 3 (a) Final Approval of the Completed Article Giulio Garaffa; David J. Ralph; Salvatore Sansalone; Rados Djinovic; Gabriele Antonini; Giuseppe Vespasiani; Francesco Pio Ieria; Sebastiano Cimino; Carla Loreto
References 1 Wilson SK. Reimplantation of inflatable penile prosthesis into scarred corporeal bodies. Int J Impot Res 2003;15(5 suppl): S125–28. 2 Martinez-Salamanca JI, Mueller A, Moncada I, Carballido J, Mulhall JP. Penile prosthesis surgery in patients with corporal fibrosis: A state of the art review. J Sex Med 2011;8:1880– 9. 3 Ralph DJ, Garaffa G, Munnez A, Freeman A, Rees RW, Christopher AN, Minhas S. The immediate insertion of a penile prosthesis for acute ischaemic priapism. Eur Urol 2008;56: 1033–8. 4 Loreto C, Barbagli G, Djinovic R, Vespasiani G, Carnazza ML, Miano R, Musumeci G, Sansalone S. Tumor necrosis factor related apoptosis-inducing ligand (TRAIL) and its death receptor (DR5) in Peyronie’s disease. A biomolecular study of apoptosis activation. J Sex Med 2011;8:109–15. 5 Gasser TC, Larsen EH, Bruskewitz RG. Penile prosthesis reimplantation. J Urol 1987;137:46–7. 6 Stember DS, Mulhall JP. Ischemic priapism and implant surgery with sharp corporal fibrosis excision. J Sex Med 2010;7:1987–90. 7 Wilson SK, Terry T, Delk JR. Improved implant survival in patients with severe corporal fibrosis: A new technique without necessity of grafting. J Urol 1996;155(Suppl 5):611A. 8 Garaffa G, Abdel Raheem AM, Spillings A, Minhas S, Christopher AN, et al. Penile prosthesis insertion in cases of severe fibrosis. J Urol 2008;179:(suppl):403. 9 Rajpurkar AA, Li HH, Dhabuwala CCB. Penile implant success in patients with corporal fibrosis using multiple incisions and minimal scar tissue excision. Urology 1999;54:145–7. 10 Knoll LD. Use of penile prosthetic implants in patients with penile fibrosis. Urol Clin North Am 1995;22:857–63. 11 Tran VQ, Lesser F, Kim DH, Aboseif SR. Penile reconstruction during difficult placement of a penile prosthesis. Adv Urol 2008 Nov 4 [Epub ahead of print] doi: 10.1155/2008/370947. 12 Shaeer O. Penoscopy: Optical corporotomy and resection for prosthesis implantation in cases of severe fibrosis, Shaeer’s technique. J Sex Med 2007;4:1214–7. 13 Shaeer O. Implantation of penile prosthesis in cases of corporeal fibrosis: Modified Shaeer’s excavation technique. J Sex Med 2008;5:2470–6. 14 Montague DK, Angermeier KW. Corporeal excavation: New technique for penile prosthesis implantation in men with severe corporeal fibrosis. Urology 2006;67:1072–5. 15 Garaffa G, Minervini A, Christopher AN, Minhas S, Ralph DJ. The management of residual curvature after penile prosthesis implantation in patients with Peyronie’s Disease. BJU Int 2011;108:1152–6. 16 Altof SE, Corty EW, Levine SB, Levine F, Burnett AL, McVary K, Stecher V, Seftel AD. EDITS: Development of questionnaires for evaluating satisfaction with treatments for erectile dysfunction. Urology 1999;53:793–9.
J Sex Med **;**:**–**
8 17 Sansalone S, Garaffa G, Djinovic R, Egydio P, Vespasiani G, Miano R, Loreto C, Ralph DJ. Simultaneous penile lengthening and penile prosthesis implantation in patients with Peyronie’s disease, refractory erectile dysfunction and severe penile shortening. J Sex Med 2012;9:316–21. 18 Lumen N, Monstrey S, Selvaggi G, Ceulemans P, De Cuypere G, Van Laecke E, Hoebeke P. Phalloplasty: A valuable treatment for patients with penile insufficiency. Urology 2008;71:272–6. 19 Garaffa G, Raheem AA, Christopher AN, Ralph DJ. Total phallic reconstruction after penile amputation for carcinoma. BJU Int 2009;104:852–6. 20 Boyd SD, Martins FE. Simultaneous Ultrex penile prosthesis reimplantation and Goretex grafting corporoplasty. J Urol 1995;153:359A. 21 Palese MA, Burnett AL. Corporoplasty using pericardium allograft (tutoplast) with complex penile prosthesis surgery. Urology 2001;58:1049–52. 22 Lopes EJ, Kuwano AY, Guimaraes AN, Flores IP, Jacobino MA. Corporoplasty using bovine pericardium grafts in
J Sex Med **;**:**–**
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complex penile prosthesis implantation surgery. Int Braz J Urol 2009;35:49–53. Pathak AS, Chang JH, Parekh AR, Aboseif SR. Use of rectus fascia graft for corporeal reconstruction during placement of a penile implant. Urology 2005;65:1198–201. Lopes EJ, Santos TC, Jacobino M. Bovine pericardium in penile prosthesis reimplantation. Int Braz J Urol 2007;33: 74–6. Ralph D, Gonzales-Cadavid N, Mirone V, Perovic S, Sohn M, Usta M, Levine L. The management of Peyronie’s disease: Evidence-based 2010 guidelines. J Sex Med 2010;7:2359–74. Carson CC, Noh CH. Distal penile prosthesis extrusion: Treatment with distal corporoplasty or Gretex windsock reinforcement. Int J Impot Res 2002;14:81–4. Kadioglu A, Sanli O, Akman T, Ersay A, Guven S, Mammadov F. Grafts materials in Peyronie’s disease surgery: A comprehensive review. J Sex Med 2007;4:581–95. Knoll LD, Furlow WL, Bilharz DL. Management of nondilatable cavernous fibrosis with the use of downsized penile prosthesis. J Urol 1995;153:366–7.
Simultaneous Total Corporal Reconstruction and Implantation of a Penile Prosthesis in Patients with Erectile Dysfunction and Severe Fibrosis of the Corpora Cavernosa jsm_2748
1..8
Salvatore Sansalone, MD,*1 Giulio Garaffa, MD, FRCS (Urol),†1 Rados Djinovic, MD,‡ Gabriele Antonini, MD,§ Giuseppe Vespasiani, MD,* Francesco Pio Ieria, MD,* Sebastiano Cimino, MD,¶ Carla Loreto, MD,** and David J. Ralph, MD† *Department of Urology, School of Medicine Tor Vergata University of Rome, Rome, Italy; †St. Peter’s Andrology, University College London Hospitals, London and Broomfield Hospital, Chelmsford, UK; ‡Department of Urology, School of Medicine, Serbian Academy of Science and Arts, University of Belgrade, Belgrade, Serbia; §Department of Urology, “U.Bracci” University La Sapienza, Rome, Italy; ¶Department of Urology, University of Messina, Messina, Italy; **Department of Bio-Medical Sciences, Anatomy Section, University of Catania, Catania, Italy DOI: 10.1111/j.1743-6109.2012.02748.x
ABSTRACT
Introduction. Implantation of a penile prosthesis in severely scarred corporal bodies represents a great challenge as fibrosis can compromise dilatation and subsequent closure of the corpora cavernosa and limit size, type, and function of the device. Aim. The aim of this study is to report our experience of simultaneous corporeal reconstruction and penile prosthesis implantation in patients with severe penile contracture consequence of diffuse fibrosis. Methods. Between March 2006 and February 2010, 18 patients with severe penile contracture and coporeal fibrosis underwent simultaneous corporeal reconstruction and placement of a penile prosthesis. Main Outcome Measures. Surgical outcome and complications have been recorded during postoperative follow-up. Patients’ satisfaction has been assessed 6 months postoperatively with the administration of the modified Erectile Dysfunction Index of Treatment Satisfaction questionnaire. Results. Although the dilatation of the corpora was extremely difficult due to the severe fibrosis, a penile prosthesis has been implanted in all patients. A malleable penile prosthesis has been inserted in four patients and a three-piece inflatable device in the remainder. After an average follow-up of 26 months (range 6–36), revision surgery was required in four patients (elective exchange to three-piece inflatable device in three patients and upsizing of the implant in one patient). Although all patients were able to achieve penetrative sexual intercourse, four patients were partially dissatisfied because of significant penile shortening. Conclusion. In expert hands, simultaneous penile prosthesis implantation and corporal reconstruction of severely scarred corpora yield satisfactory results. Patients must be warned that complication rate in presence of severe fibrosis is significantly higher than in virgin cases and that downsized cylinders might be required due to the contracture of the tunica albuginea. Sansalone S, Garaffa G, Djinovic R, Antonini G, Vespasiani G, Ieria FP, Cimino S, Loreto C, and Ralph DJ. 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 **;**:**–**. Key Words. Low Flow Priapism; Erectile Dysfunction; Infection; Erosion; Inflatable Penile Prosthesis; Malleable Penile Prosthesis; Graft
1
Both authors have contributed equally to the production of this article.
© 2012 International Society for Sexual Medicine
J Sex Med **;**:**–**
2
Sansalone et al.
Introduction
D
ense corporeal fibrosis (CF) poses a severe challenge to the implanting surgeon as dilatation of the corpora can be extremely difficult. Due to the contracture of the tunica albuginea, downsized cylinders are often required, and a penile shortening of up to 4–6 cm is a common finding [1]. Penile fibrosis usually occurs following explantation of infected penile prosthesis, refractory low flow priapism, severe penile trauma, Peyronie’s disease (PD), and intracavernosal injection of vasoactive drugs [2–4]. Among all these conditions, explantation of an infected penile implant leads to a more significant degree of scarring and contracture, and this group of patients is characterized by a more extensive and dense fibrosis in the crura than in the shaft [5]. Patients with refractory ischemic priapism instead tend to develop severe distal fibrosis with relatively normal crura, and therefore penile prosthesis implantation is relatively easier [6]. Over the years, multiple surgical approaches have been suggested to facilitate penile prosthesis implantation in patients with severe CF. Extensive corporotomies or distal second incisions, excision of the scarred tissue, and the use of the Otis urethrotome, cavernotomes, and resectoscope loops has shown to be useful to create sufficient space to house the cylinders in the vast majority of patients. However, in some cases, the degree of scarring and contracture is so severe that closure of the tunica albuginea over a penile implant is impossible, and therefore reconstruction of the corpora with a patch becomes necessary [1,2,7–14]. This series reports the long-term outcome from patient’s and surgeon’s perspective of simultaneous corporeal reconstruction and penile prosthesis implantation in patients’ severe fibrosis and contracture of the corpora cavernosa.
Methods and Main Outcome Measures
Between March 2006 and February 2010, 18 patients with severe corporeal scarring and penile shortening underwent simultaneous corporeal reconstruction and insertion of a penile prosthesis (Figure 1). All patients had previously undergone implantation of a penile prosthesis and subsequent removal of the infected implant in another institution. Two patients have had a repeated attempt of implantation, but the device was then removed because of infection in one case and erosion in the J Sex Med **;**:**–**
Figure 1 Severe corporeal scarring with penile shortening consequence of explantation of an infected penile prosthesis.
other. Overall, seven patients were diabetics (39%), and the indication for the initial implantation of the erectile device was refractory erectile dysfunction in 12 patients and PD in six patients. Prior to surgery, all patients have been adequately counseled about the potential intraand postoperative complications, including urethral perforation, crossover, corporal injury, penile prosthesis infection, erosion, and mechanical failure. Patients were aware that implantation of a penile prosthesis in severely fibrotic corpora is associated with high complications rate, that the procedure would have been abandoned in case of urethral injury, and that the expected postoperative penile size would not be longer than the preoperative stretched penile length [1]. After adequate counseling about the different types of penile implants, 14 patients opted for a three-piece inflatable device (AMS 700 CX, American Medical Systems, Minnetonka, MN,
Implantation of Prosthesis and Total Corporal Reconstruction USA) and the remainder for a malleable one (AMS 650 11 mm, American Medical Systems). Surgical Technique
All patients underwent implantation of the device after intravenous administration of Gentamicin (Sandoz, Holzkirchen, Germany) and Amoxicillin/ Clavulanic acid (Co-Amoxiclav, GlaxoSmithKline, London, UK) and 10 minutes scrub of the surgical field with povidone-iodine (Betadine, Meda, Sweden). Surgery was carried out through a longitudinal scrotal incision that was extended on the ventral aspect of the shaft up to the corona in order to guarantee adequate exposure of the corpora from the crura to the distal tips. Once a complete exposure of the corpora was achieved, two longitudinal corporotomies, one on each side of the urethra, were carried out from the crura to the coronal sulcus and the scarred cavernosal tissue dissected off the tunica albuginea. This procedure has been carried out with blunt dissection with Metzenbaum scissors. The use of the hand-held diathermy was avoided if possible in order to prevent thermal damage to the neurovascular bundle and consequent postoperative glans numbness (Figure 2). Once the scarred tissue was completely excised, the tunica albuginea was carefully assessed. A total corporeal reconstruction was performed only if the tunica was so severely contracted and inadequate that closure over a 9 mm Hegar could not be accomplished without tension, thus precluding
Figure 2 Once the corpora are exposed through a midline ventral incision, the two corporotomies are extended from the crura to the corporeal tips, and the fibrotic cavernosal tissue is excised with blunt dissection.
3
even the insertion of an AMS 600 or of an AMS CXR (American Medical Systems, Minnetonka, Minnesota, USA). Proximal blunt dissection was carried out carefully under vision with Metzenbaum scissor first and with cavernotomes subsequently. In four patients, proximal fibrosis was so dense that blunt dissection could not be performed safely, and therefore the corporotomies were extended proximally almost to the tip of the crura. In one patient, a proximal perforation was recognized intraoperatively and managed successfully with an anchoring suture in 0 Polydioxanone (PDS II; Ethicon Inc., Somerville, NJ, USA). Under a continuous irrigation of the surgical field with Gentamicin solution, the ventral aspect of the corpora was reconstructed with the use of porcine dermis (InteXen, American Medical Systems) patch graft in 11 patients and acellular collagen dermis (Pelvicol, Bard Medical, Murray Hill, NJ, USA) in the remainder. All sutures have been carried out with 2-0 Polydioxanone in a running fashion (Figure 3). Reconstruction of the corpora has bee carried out over an 11 mm Hegar dilator in patients undergoing implantation of an inflatable device and directly on the rods in patients who have opted for a malleable prosthesis. The inflatable rods were inserted after the reconstruction of the corpora to prevent inadvertent perforation of the cylinders (Figure 4). Insertion of reservoir and pump were carried out in the usual fashion, and after the closure of dartos and skin with running 3-0 polyglactin sutures (Vicryl, Ethicon Inc., Somerville, NJ, USA) (Figure 5), a light compressive dressing was applied to shaft and scrotum to reduce the risk of edema and hematoma formation. A 12-French suction drain was left postoperatively in the scrotum in all patients, and the cylinders of the AMS 700 CX were left semi-inflated. Patients were discharged home with 2 weeks of oral Amoxicillin/Clavulanic acid (Co-Amoxiclav, GlaxoSmithKline) on postoperative day one after the removal of compressive dressing and drain and, in case of implantation of an inflatable device, once the prosthesis were successfully deflated. Postoperative follow-up was started 4–6 weeks postoperatively, and patients who have had a three-piece inflatable penile prosthesis implanted were encouraged to cycle the device on a daily basis to prevent further scar formation around the cylinders, as this might have led to further shortening or deformity. Sexual activity was encouraged once the skin wounds were completely healed, and J Sex Med **;**:**–**
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Sansalone et al. A
B
C
Figure 3 The ventral aspect of the corpora is reconstructed with a Pelvicol patch and running 2-0 Polydioxanone sutures. (A) In patients undergoing implantation of an inflatable device, reconstruction is performed over an 11-cm Hegar dilator in order to prevent inadvertent perforation of the cylinders. (B) The reconstruction is started at the level of the tips and continued proximally to the base of the penis. (C) In case of implantation of a semirigid rod, the reconstruction is carried out directly over the cylinders.
the patient was comfortable with inflating and deflating the device. Surgical outcome and postoperative complications were recorded in the postoperative follow-up that was scheduled at 6 months and every year thereafter. Patients’ satisfaction was assessed at the 6 months postoperative follow-up visit with the administration of the modified Erectile Dysfunction Index of Treatment Satisfaction (EDITS) questionnaire [15–17]. Surgical outcome and patients’ satisfaction were then assessed subjectively by the surgeon in the subsequent visits. Results
The average age at the time of surgery was 58 years (range 46–65 years), and the mean time from J Sex Med **;**:**–**
the explantation of the previous device was 14 months (range 7–18). When comparing the size of the implanted cylinders with the one of the previously explanted rods, the average loss of length was 3 cm (range 2–4.5). Overall, postoperative complications consisted in superficial scrotal wound dehiscence and a small scrotal hematoma, respectively, in two and three patients and were managed conservatively with the prolonged administration of broad spectrum antibiotics. Revision surgery was required in four patients (22%); the indications were elective exchange of an AMS 650 to an AMS 700 CX in three patients and to upsize an inflatable implant in one patient. The average increase of length in patients who have undergone elective exchange of a malleable device to a three-piece inflatable was 2 cm (range
Implantation of Prosthesis and Total Corporal Reconstruction
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A
B
Figure 4 The reconstructed corpora after the implantation of the cylinders. (A) The cylinders of AMS 700 CX are comfortably housed into the reconstructed corpora. (B) The reconstruction after implantation of the AMS 650 11 mm malleable penile prosthesis.
1–3.5) while a gain of 3 cm was achieved after upsizing of the device. After an average follow-up of 26 months (range 6–36), the prosthesis was sitting in the correct position, and the penis was reasonably straight and rigid enough to guarantee successful sexual penetration in all cases; all patients who have undergone implantation of a three-piece inflatable penile prosthesis were able to cycle the device. Overall, 14 patients returned the modified EDITS questionnaire at the 6 monthly postoperative review, and the results are shown in Table 1. Overall, 10 patients (71%) were fully satisfied with the cosmetic and functional result of surgery. Although no patient complained of postoperative shortening, four patients were not satisfied with penile length. Discussion Figure 5 The final result after implantation of the AMS 650 and closure of Dartos and skin with 3-0 Vicryl sutures.
Penile prosthesis implantation in patients with severe fibrosis of the corpora cavernosa still repreJ Sex Med **;**:**–**
6 Table 1
Sansalone et al. Patients’ satisfaction 6 months postoperatively
Domain
Outcome measure(s)
Overall satisfaction (domain #1)
Satisfied (1 and 2) 10 (71%) Halfway (3) 20 Somewhat dissatisfied (4 and 5) 4 (29%)
Overall confidence (domain #4)
Confident (1 and 2) 10 (71%) Halfway (3) 0 Somewhat dissatisfied (4 and 5) 4 (29%)
Postoperative penile Satisfied (1 and 2) length (domain #9) Halfway (3) Dissatisfied (4 and 5)
Outcome
10 (71%) 0 4 (29%)
sents a challenge and is associated with low levels of patients’ satisfaction because of penile shortening and elevated rate of intra- and postoperative complications [1–14]. Although extremely difficult, dilatation of severely fibrotic corpora can be achieved with complete exposure of the corpora cavernosa, extended or multiple corporotomies, and the use of cavernotomes, Otis urethrotomes, and resection loops. However, patients with associated severe contracture of the tunica albuginea and penile inadequacy still represent a surgical dilemma as the simple dilatation of the corpora cavernosa, if feasible, would not create enough space to house downsized cylinders. Therefore, traditionally, this group has been managed with total phallic reconstruction with the use of infraumbilical, groin, or free flaps [18]. Although total phallic reconstruction with the use of the radial artery-based forearm free flap guarantees excellent cosmetic and functional results and represents the best technique available at the moment [19], patients are always better served if their penis is preserved. Therefore, simultaneous corporeal reconstruction and penile prosthesis implantation should be always attempted in patients with penile inadequacy as a consequence of CF and albuginea scarring. Although the use of patch grafts to cover limited tunical defects after the implantation of a penile prosthesis in patients with severe fibrosis has been already described, this is the largest series
Table 2 fibrosis
of simultaneous total corporeal reconstruction and insertion of erectile devices reported so far (Table 2) [20–24]. This series confirms that satisfaction rates in patients undergoing penile prosthesis implantation in severely scarred corpora tend to be low [1,4,7,8]. Moreover, the fact that after a median follow-up of 26 months that no case of mechanical failure has been recorded suggests that there has been a significant improvement in the reliability of the inflatable penile implants when compared with previous data [1,8]. The use of grafts has been very popular after the excision of the fibrotic tissue when the tunica albuginea does not allow closure of the corpora cavernosa. In fact, defects in the tunica albuginea larger than 1 cm, if left not covered, are associated with increased risk of aneurysmal dilatation of the cylinders, erosion, migration, infection, and mechanical failure of the device [2,25,26]. Graft materials can be classified in three categories: synthetic, autologous tissue, and extracellular matrix. The most common synthetic grafts are Goretex (Polytetrafluoroethylene, Gore Medical, Flagstaff, Arizona, USA) and Dacron (Polyethylene terephthate, Gore Medical, Flagstaff, Arizona, USA), while the most common autologous materials used in prosthetic surgery are saphenous vein, dermis, buccal mucosa, rectus fascia, and fascia lata. Bovine and cadaveric pericardium, porcine small intestine submucosa, and cadaveric fascia lata represent instead the extracellular matrix grafts [27]. Each graft in material has its own advantages and drawbacks in terms of availability, antigenicity, and cost effectiveness. The main disadvantage of synthetic grafts is their immunogenicity, which translates in a significantly increased penile prosthesis infection rate, which has been reported as high as 30%, while donor size morbidity, limited availability, and increased operative time are the downsides of autologous materials [28]. Extracellular matrix grafts instead are not associated with donor site morbidity and limited avail-
Series describing the use of patch grafts for complete corporeal reconstruction in patients with severe corporeal
Author
Year
No. of patients
Graft material
Complications
Follow-up*
Tran et al. and Patak et al. [11,23] Lopes et al. [24]
2008 2007
8 1
Rectus fascia Pericardium
0 0
18 24
*Follow-up in months
J Sex Med **;**:**–**
Implantation of Prosthesis and Total Corporal Reconstruction ability and according to various authors are not associated with increased infection rates of the prosthetic device, although larger series will be necessary to confirm these data [17,21]. Therefore, extracellular matrix grafts represent the material of choice when grafting is required. Although no patient developed penile prosthesis infection and ultimately required explantation of the device, grafts should be avoided when possible in penile prosthetic surgery [7]. In this series, the only indication for corporeal reconstruction with the use of grafts was severe contracture and insufficiency of the tunica albuginea that would have precluded closure over an AMS 600 or an AMS CXR. When possible, patients are better served without the use of grafts even at the expense of using a downsized implants as with regular cycling and use, the device acts as a tissue expander and many of these patients will be able to undergo replacement of the downsized cylinders with standard diameter, longer cylinders [1,2,7]. Conclusion
This series confirms that in expert hands, total corporeal reconstruction is a safe and reliable technique in patients with penile inadequacy consequence of severe corporeal scarring and albugineal contracture. Because patients’ satisfaction rates are low because of unrealistic expectations, an adequate and thorough preoperative counseling is necessary. Corresponding Author: Salvatore Sansalone, MD, Policlinico di Tor Vergata, University of Rome, Viale Oxford 81, Rome 00133, Italy. Tel: +393471792019; Fax: +390620902975; E-mail: salvatore.sansalone@ yahoo.it Conflict of Interest: None. Statement of Authorship
Category 1 (a) Conception and Design Salvatore Sansalone; Giulio Garaffa; Rados Djinovic; Gabriele Antonini; Giuseppe Vespasiani; Francesco Pio Ieria; Sebastiano Cimino; Carla Loreto (b) Acquisition of Data Salvatore Sansalone (c) Analysis and Interpretation of Data Giulio Garaffa
Category 2 (a) Drafting the Article Giulio Garaffa
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(b) Revising It for Intellectual Content Giulio Garaffa; David J. Ralph; Salvatore Sansalone
Category 3 (a) Final Approval of the Completed Article Giulio Garaffa; David J. Ralph; Salvatore Sansalone; Rados Djinovic; Gabriele Antonini; Giuseppe Vespasiani; Francesco Pio Ieria; Sebastiano Cimino; Carla Loreto
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