International Journal of Impotence Research (2014) 27, 49–53 © 2014 Macmillan Publishers Limited All rights reserved 0955-9930/14 www.nature.com/ijir
ORIGINAL ARTICLE
Inflatable penile prosthesis technique and outcomes after radial forearm free flap neophalloplasty RL Segal1, EZ Massanyi1,2, AD Gupta1, JP Gearhart1,2, RJ Redett3, TJ Bivalacqua1 and AL Burnett1 The aim of this study was to describe the technical aspects and short-term outcomes of inflatable penile prosthesis (IPP) implantation after neophallus reconstruction at a single institution. Nine men with previously constructed radial forearm neophalli underwent IPP implantation. The etiologies of their penile anomaly were bladder exstrophy complex in five, disorder of sexual differentiation in two and genital obliteration secondary to ballistic trauma in two. Median follow-up was 9.6 months (range 1.5–139.7). The records for these patients were retrospectively reviewed and outcomes recorded. Mean age was 23.6 (range 18–31) years, and mean time interval from neophalloplasty to IPP implantation was 22.1 months (range 3–48). In all cases, 3-piece IPPs were employed, with eight of patients having one cylinder implanted in the native corporal body and extending into the neophallus. Mean surgical time was 222 min (range 142–409). Median length of implanted device was 22 cm. No intraoperative complications were observed. At the most recent follow-up, six patients (66.7%) had functional devices, with acceptable surgical outcomes. Three patients (33.3%) sustained device infections, and three (33.3%) sustained cylinder erosion. In three patients in whom neo-tunica albuginea were fashioned by ensheathing the cylinder with allograft human dermal tissue matrix, no erosions occurred. One patient underwent two revisions, the first for the associated erosion and infection and the second for genital pain, and was left with a semi-rigid prosthesis. IPP implantation affords the best opportunity for functionality for patients with a radial forearm free flap neophallus. Caution must be taken to ensure viability of the neophallus intraoperatively, and protocols to minimize the risk of infection should be followed. Fashioning neo-tunica albuginea using graft material may reduce risk of erosion. International Journal of Impotence Research (2014) 27, 49–53; doi:10.1038/ijir.2014.30; published online 7 August 2014
INTRODUCTION As a result of evolving understanding of male genital anatomy and continued surgical ingenuity, men with severe genital anomalies or loss are able to experience successful sexual relationships. Men with congenital birth defects (aphallia, micropenis, classic bladder exstrophy/epispadias complex, cloacal exstrophy), ambiguous genitalia, a history of penile trauma resulting in penile destruction, a history of penectomy due to malignancy or female-to-male gender reassignment are now candidates for penile reconstruction, which allows the possibility of resumption of sexual activity. The most common tissue flap sources for neophallus reconstruction are free flaps derived from the radial forearm, but options also include tissue from the anterolateral thigh, the scapula/latissimus dorsi, fibula, and local rotational flaps from the abdomen, groin and thigh.1 The ultimate means to restore erectile function for these men involves implantation of a penile prosthesis. Although it is reported that men with a neophallus alone are able to engage in penetrative intercourse successfully,2 most reports of men with neophalli document the implantation of a penile prosthesis as the final step in the surgical reconstructive course.3–7 Although neophalli have an impressively natural aesthetic appearance (Figure 1), they are comprised solely of soft tissue, and thus they typically cannot generate the rigidity needed for penetration. The purpose of this study is to review our series, highlighting the technical aspects of contemporary inflatable penile prosthesis
(IPP) implantation in the neophallus. Although at our institution the preferred approach for neophallus reconstruction is to employ a radial forearm free flap, the features of IPP implantation discussed here are appropriate for neophalli derived from any tissue source. We also report on the outcomes of this surgery, and identify comorbid factors that influence surgical success. MATERIALS AND METHODS Data accrual After obtaining institutional review board approval, a database of all patients undergoing implantation of a penile prosthesis at our hospital from 1 January 2000 to 31 December 2011 was retrospectively compiled. Patients were identified on the basis of querying the GE Centricity Professional Fee Billing System for Current Procedure Terminology (CPT) procedure codes from hospital records, and all pertinent information was collected from the electronic medical record and transferred into a computerized database. A total of nine patients were identified with previous radial forearm neophallus reconstruction who underwent IPP implantation (performed by TJB and ALB).
Data collection Variables collected included patient demographic parameters, medical comorbidities, details of the surgery (date, surgeon, duration of surgery [time from anesthesia induction to the patient’s transfer out of the operative suite], perioperative antibiotics employed, mode of anesthesia
1 The James Buchanan Brady Urological Institute, The Johns Hopkins Medical Institutions, Baltimore, MD, USA; 2Division of Pediatric Urology, The Johns Hopkins University School of Medicine, Charlotte Bloomberg Children's Hospital, Baltimore, MD, USA and 3Department of Plastic and Reconstructive Surgery, Johns Hopkins School of Medicine, Baltimore, MD, USA. Correspondence: Dr AL Burnett, The James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions, 600 North Wolfe Street, Marburg 407, Baltimore, MD 21287, USA. E-mail: [email protected] Received 10 September 2013; revised 13 May 2014; accepted 26 June 2014; published online 7 August 2014
IPP after neophalloplasty RL Segal et al
50
Figure 2. Appearance of neophallus before IPP implantation. Arrow indicates position of native glans exposed at the ventral base of the neophallus.
Figure 1.
Appearance of a neophallus before IPP implantation.
employed, duration of hospitalization), surgical outcomes (infection, erosion [defined as physical extrusion of any component of the device through either skin or urethra] or mechanical failure [defined as any circumstance where the patient is not satisfied with the operability of the device, which requires surgical revision]) and clinical follow-up. For this study, follow-up consisted of outcomes noted in their most recent hospital clinic visit.
Description of surgery Penile prosthesis implantation in a reconstructed neophallus is a technically demanding surgery, for which the surgical approach has previously been described.8–11 Our approach is similar, and will be described now. As for men with native phalli, patients are treated perioperatively with antibiotics, and all the same precautions to mitigate the risk of infection are taken.12 General anesthesia is employed, and patients are placed either in supine or low lithotomy position, depending on the underlying etiology of the patient’s penile anomaly and the extent of reconstruction that will be required. Men with native corporal bodies, such as those with bladder exstrophy, may be approached similarly to men with native phalli with a penoscrotal approach. For those who had not undergone neocrura reconstruction as part of their phalloplasty, prosthesis fixation is required to ensure its stability, which may be feasibly performed through a penoscrotal incision. Conversely, patients with neocrura derived from synthetic materials should be positioned in low lithotomy, so that perineal access to the proximal aspect of the neocrura is possible. Appreciation of the anatomy of the neophallus is critical. It is advisable to have the reconstructive surgeon who performed the phalloplasty available should his expertise be required. If a diminutive native phallus is incorporated into the neophallic reconstruction (most commonly at the phallic base) to preserve erogenous sensation, its presence should be noted (Figure 2). The position of the neophallic arterial supply should be documented with intraoperative Doppler ultrasound. If the neophallus was reconstructed with a neourethra through which voiding occurs, it should be gently catheterized so that the position of the urethra is notable at all times. Additionally, consideration should be taken for suprapubic catheter urinary diversion so that the urethral catheter may be removed as soon as possible postoperatively to limit the duration of the foreign body’s presence within the neourethra and risk of tissue breakdown. If the patient is already surgically diverted via catheterizable stoma, this stoma should be catheterized to monitor urine output during surgery, but the catheter may be removed afterwards so that the patient is able to resume selfcatheterization. International Journal of Impotence Research (2015), 49 – 53
Figure 3.
Proximal corporal dilation with a Hegar dilator.
If a penoscrotal incision is to be used, careful dissection to expose the native corporal bodies is the initial surgical step. This portion of the procedure may be challenging, particularly when the corporal bodies are diminutive. Once identified, the surgeon must determine whether it is possible to implant two cylinders, based on the girth of the neophallus. Although the presence of two cylinders may achieve symmetry, the neophallus may not be able to accommodate them suitably when fully inflated, in which case one cylinder is preferred. If one cylinder is to be implanted, then the more stout corporal body should be selected for implantation, though the location of the neophallic blood supply may influence this decision. A corporotomy is made, and proximal dilation to the crus is performed (Figure 3). Distal dilation is performed, and the corporal body is carefully perforated anterolaterally through the dorsal tunica albuginea, allowing the dilator to pass into the neophallus. This maneuver is critical, as corporal perforation too medially at the dorsal aspect of the native phallus may injure its dorsal penile nerve and compromise erogenous sensation. Neophallic dilation is performed, and the phallic length is measured. The appropriately sized IPP is selected (Figure 4), and depending on the girth of the neophallus, slender cylinder(s) (such as the AMS 700 CXR (Minnetonka, MA) or Coloplast (Minneapolis, MN) narrowedbased) may be used. In order to provide additional protection against cylinder erosion, the surgeon may elect to cover the distal cylinders with a sleeve of graft material, either allograft or xenograft, which serves as an extra layer ensheathing the IPP cylinders. If so, the dimensions are measured and the graft material is folded into a cylinder and the edges sutured together (similar to a cigar in a cigar tube). This cylindrical sleeve is then applied © 2014 Macmillan Publishers Limited
IPP after neophalloplasty RL Segal et al
51
Figure 4.
Table 1. Patient
Appearance of neophallus with a single cylinder implanted, before scrotal pump positioning.
Preoperative patient characteristics Age (years) at time of IPP implantation
1 2 3 4 5 6 7 8 9
20 20 23 27 31 22 25 18 26
Diagnosis
Phalloplasty procedure
CBE, penile inadequacy CBE, penile inadequacy CBE, penile inadequacy, epispadias Genital trauma-penile loss DSD Genital trauma-penile loss Cloacal exstrophy, penile inadequacy CBE, penile inadequacy, epispadias DSD
MRFFFP MRFFFP MRFFFP MRFFFP N/A MRFFFP MRFFFP MRFFFP MRFFFP
(left) (left) (left) (left) (left) (left) (right) (left)
Time from phalloplasty (months) 9 19 19 48 3 25 17 11 48
Abbreviations: CBE, classic bladder exstrophy; DSD, disorder of sexual differentiation; MRFFFP, microvascular radial forearm free flap phalloplasty; N/A, not applicable.
over the IPP cylinder(s), which are then implanted routinely. Corporotomy closure is then performed. Given that most of these patients have had previous lower abdominal or inguinal surgeries, ectopic reservoir implantation is generally employed. The scrotal pump is placed routinely in a subdartos pouch. For men with prior constructed neocrura, ideally the cylinders should be positioned within them so that the cylinders are anchored and will not move within the neophallus. Depending on their proximal extent, the neocrura may be accessed via a perineal approach. Dilation is then performed within these neocrura, and the cylinders are positioned within them. For men without either native crura or neocrura, the IPP needs to be anchored to ensure its stable position within the neophallus. IPP anchoring may be accomplished by its osseous fixation to the pubic symphysis13 or inferior pubic rami,14 by suturing the rear-tip extender directly to the bone, or by placing the cylinders within cylindrical sheathes of graft material constructed as neocrura.8–10
Clinical protocol Patients are kept in hospital for observation for typically one night, and discharged home on postoperative day 1. The scrotal drain is removed when drainage has reached a nadir. Follow-up consists of a clinic visit at least 6 weeks postoperatively to verify postoperative recovery and to instruct the patient on pump © 2014 Macmillan Publishers Limited
manipulation. The most important aspect of this instruction is to ensure that the patient is proficient with the deflation mechanism to avoid tissue necrosis effects that result in cylinder erosion associated with partially inflated devices. Sensation in the neophallus may be incomplete, however, and patients may not experience the same discomfort as a warning to deflate the device circumventing cylinder erosion.
RESULTS Patient baseline preoperative characteristics are listed in Table 1. Of the nine patients, eight underwent neophalloplasty at our institution, derived from radial forearm free flap, at a mean of 22.1 (range 3–48) months prior to IPP implantation. The etiology of penile anomaly was bladder exstrophy complex in four, cloacal exstrophy in one, disorder of sexual differentiation in two, and genital loss secondary to ballistic trauma in two. Mean age at the time of IPP implantation was 23.6 (range 18–31) years. Median body mass index was 26.5 kgm − 2. Eight out of nine patients had no previous attempts at IPP implantation. One patient previously had a semi-rigid prosthesis with which he was not satisfied, which prompted IPP implantation at another institution. This device International Journal of Impotence Research (2015), 49 – 53
IPP after neophalloplasty RL Segal et al
International Journal of Impotence Research (2015), 49 – 53
IPP salvaged 14 No Yes 409 Yes
Functional IPP — No 162 Yes
9
Abbreviations: IPP, inflatable penile prosthesis; N/A, not applicable.
18 AMS 700 CXR
AlloDerm sheath encasing IPP cylinders AlloDerm sheath encasing IPP cylinders 22 AMS 700 CX 8
AMS 700 CX
Infrapubic; 2nd incision for reservoir; 3rd incision for pump Penoscrotal; 2nd incision for reservoir Penoscrotal; 2nd incision for reservoir 7
12
No
Functional IPP — No No 173
No Yes N/A
Proximal Windsock (Tutoplast Yes pericardium) anchored to native CB AlloDerm sheath encasing IPP Yes cylinders 24 Mentor Alpha I Lateral Penoscrotal 6
4 5
3
2
14
Functional IPP Replaced with semi-rigid prosthesis, which also eroded, not replaced IPP salvaged; Eventually replaced with semi-rigid prosthesis — 50 AMS 700 CX AMS 700 CX
27 24
None None
Yes Yes
N/A 288
No No
No Yes
Functional IPP — None 15
No
183
No
No
IPP explanted and not replaced 288 Yes Yes 202 No None 12
AMS 700 CXR AMS 700 CX
141 Yes No 142 No None AMS 700 CX
Lateral penoscrotal; 2nd incision for reservoir Infrapubic; 2nd incision for reservoir Penoscrotal; 2nd incision for reservoir Penoscrotal Penoscrotal 1
22
Drain (yes/no) Total IPP Adjuvant maneuvers length (cm) IPP type Patient Surgical approach
Surgical procedures and outcomes
Table 2.
DISCUSSION As demonstrated in this study, IPP is feasible in neophalli. However, although effective at restoring erectile function with satisfactory outcomes, IPP implantation in men with neophalli is associated with greater risk of complications than in men with normal native phalli. Risks of device infection and erosion (both 33.3%) were shown to be considerably higher than those reported in the contemporary standard phallic IPP literature (1–8%).15,16 The main emphasis of this report is to highlight the surgical principles of IPP implantation in a neophallus. These include (i) initial identification of critical structures, including the vascular supply of the neophallus, and the neourethra (if present), to ensure safety and prevent iatrogenic injury; (ii) anchorage of the prosthesis within the native corporal body or to the surgically reconstructed neocrura, depending on the underlying etiology of penile loss; (iii) cylinder ensheathment with a sleeve of graft material to mitigate against percutaneous neophallic cylinder erosion. This last point is of particular importance, because early in our series, three out of six (50%) patients did not undergo this step sustaining subsequent cylinder erosion, whereas this modification later resulted in no patient sustaining erosion. Other considerations in the context of managing erosion, such as downsizing the cylinder(s) or primary neophallic repair, while possible, result in our opinion in suboptimal outcomes, such as destabilization of the erect neophallus or further risk of device infection, respectively. As such, preventing erosion from occurring altogether should be
Surgical time Infection Erosion Time to adverse Outcome (min.) event (days)
subsequently became infected which was explanted at our institution 8 months prior to IPP re-implantation. The surgical details for each patient are listed in Table 2. Surgical approaches were either penoscrotal or infrapubic, with this decision based on what was thought to be the most direct access to the corporal bodies, as well as the lowest risk to the vascular supply to the neophallus. All patients had one cylinder implanted, except patient #9, who had two. Given the extensive previous surgical history of the majority of these patients, a counter-incision in the lower abdomen was made for reservoir placement in six patients, with one patient requiring an additional scrotal incision for proper pump placement. Four patients had adjuvant maneuvers to optimize positioning of the cylinders within the neophallus, including a proximal windsock derived from allograft pericardium in one patient, and acellular human dermis allograft neotunica construction for the neophallus in three patients. Mean operative duration was 222 min (range 142–409). Median follow-up was 9.6 months (range 1.5–139.7). Three out of nine (33.3%) patients developed infections of their IPP, one with associated device erosion through the distal tip of the neophallus, and two developed wound breakdown with exposure of underlying device components (Table 2). Two patients developed distal cylinder erosion through the neophallus without associated clinical infection, for an erosion rate of 33.3% (3/9). In one of those cases (patient #1), it was noted that the IPP was never fully deflated, which presumably explains the cause for erosion: chronic pressure within the neophallus from the inflated IPP cylinder resulting in distal ischemia and eventual erosion. In the two patients with wound separation, the indwelling IPP was salvageable with washout and secure wound closure. In one of these patients, as a result of chronic genital pain, the IPP was eventually removed and replaced with a semi-rigid prosthesis, 7 years later. The combined complication rate (erosion or infection or both) was five out of nine (55.6%). No patient had mechanical functional failure of the device. At the last follow-up, six patients possess stable, intact devices, and one out of six (16.7%) is sexually active by report. No explicit reasons were given as to why those five out of six patients with intact devices are not sexually active.
IPP explanted and not replaced
52
© 2014 Macmillan Publishers Limited
IPP after neophalloplasty RL Segal et al
53 striven for, which in our mind is best accomplished by cylinder ensheathment. Multiple reports have documented the feasibility, safety and success of penile prosthesis implantation in a neophallus. Hoebeke et al.3 reported on 35 gender reassignment patients, of whom 10 received semi-rigid and 25 received inflatable devices. Successful implantation occurred in all 10 patients receiving a semi-rigid device, although 1 patient underwent revision to have a 3-piece IPP implanted. In the IPP group, complications (infection, neophallus necrosis and/or erosion) occurred in five patients (20%). In a report with longer-term follow-up from the same group, with 120/129 gender reassignment patients receiving 3-piece IPPs, there was a 41.1% risk of surgical removal or revision of the prosthesis at a mean follow-up of 30.2 months for device infection, erosion or malfunction.4 Of all IPPs used in this cohort, 108/185 (58.4%) still remained in place after initial implantation, with a total infection rate of 11.9%, erosion rate of 8.1%, prosthesis malfunction rate of 22.2% and malposition rate of 14.6%. Bettocchi et al.2 reported that among 17 patients with neophalli who underwent penile prosthesis surgery, 6 of 8 receiving semirigid prostheses sustained erosions. Perovic14 reported successful penile prosthesis insertion in eight men (three IPP; five semi-rigid) with a variety of penile anomalies without complication. Lumen5 reported that in men undergoing neophallus reconstruction, two out of four men required penile prosthesis explantation because of infection. In Garaffa’s6 series of men undergoing neophallus construction status post penile carcinoma treatment, four out of five men had successful IPP implantation, with one device explanted as a result of infection. Special consideration should be given to men with classic bladder exstrophy or cloacal exstrophy. Anatomical distortions of the pelvis, namely diastasis of the symphysis pubis, as well as the native penis, most notably a shorter anterior corporal segment (distal from the pelvic attachment), and a greater intercorporal distance,17 may contribute to a heightened risk of complications associated with IPP implantation in a neophallus. With angulated proximal support, the position of the cylinder may deviate oppositely within the neophallus. We postulate that this contributes specifically to the risk of erosion for IPP in neophalli, reported here and elsewhere.7 This complication occurred because of incomplete deflation of the cylinder, which exerted lateral pressure at the distal neophallus. Counseling is critical for the patient to fully understand these risks and adhere to instructions for device use to try to mitigate them. For men with neophalli, preoperative counseling about risk of adverse events and realistic outcome expectations is critical for both patient understanding and medicolegal considerations. Should any surgeries, either aesthetic or functional, be required on the genitalia (including but not limited to neophallic revision for any reason, tattooing, urethroplasty or scrotoplasty), these should be completed prior to penile prosthesis implantation. This sequence is recommended because any post-prosthesis surgical intervention may result in inadvertent damage to the device, or may cause exposure of device components, which will increase the risk of prosthetic infection. Of additional importance is consideration for scrotoplasty. For IPPs, the pump is routinely placed within the scrotum for easy pump manipulation. As such, for proper surgical planning, the scrotum must be adequately sized to accommodate the pump within a subdartos pouch. Although placement is often easily achieved even in men with diminutive scrota (such as post-trauma, post-scrotectomy or possibly femaleto-male transgender patients), any plans for scrotal enhancement surgery, whether in the form of grafting or tissue expansion, should be pursued prior to penile prosthesis implantation. Ectopic pump placement has not been reported, and in the situation where the size of the scrotum limits pump placement, the patient may have to assume the inherent risks of a semi-rigid prosthesis. IPPs generally
© 2014 Macmillan Publishers Limited
are preferred over semi-rigid prostheses to limit constant pressure within the neophallus, which may predispose to cylinder erosion, described above. Special attention should be given to arterial blood supply to the flap to avoid its disruption, which can result in ischemia, necrosis and loss of the neophallus, the most dreaded outcome of penile prosthesis implantation. If it is felt that during surgery survival of the neophallus may be jeopardized, then a decision to abort prosthesis insertion may be necessary. Once the surgery is complete, the patient must allow for an extended period of recovery for healing. Our report has some potential limitations. Our series represented a small number of patients, with limited follow-up. This reflects the relative novelty of undertaking this surgery at our institution, as well as the fact that our cohort includes two-thirds international patients for whom routine follow-up is extremely difficult. Finally, we did not formally assess patient satisfaction or quality of life outcomes associated with their surgery. In conclusion, implantation of IPP in men with reconstructed neophalli is complex and should only be undertaken by experts, with the understanding that surgical plans depend on the etiology of the native penile anomaly and anatomic constraints of the neophallus. Risk of adverse events is considerably higher in this patient population, and informed consent is critical. Nevertheless, successful surgical outcomes may be achieved. CONFLICT OF INTEREST The authors declare no conflict of interest.
REFERENCES 1 Bluebond-Langner R, Redett RJ. Phalloplasty in complete aphallia and ambiguous genitalia. Semin Plast Surg 2011; 25: 196–205. 2 Bettocchi C, Ralph DJ, Pryor JP. Pedicled pubic phalloplasty in females with gender dysphoria. BJU Int 2005; 95: 120–124. 3 Hoebeke P, de Cuypere G, Ceulemans P, Monstrey S. Obtaining rigidity in total phalloplasty: experience with 35 patients. J Urol 2003; 169: 221–223. 4 Hoebeke PB, Decaestecker K, Beysend M, Opdenakker Y, Lumen N, Monstrey SM. Erectile implants in female-to-male transsexuals: our experience in 129 patients. Eur Urol 2010; 57: 334–341. 5 Lumen N, Monstrey S, Selvaggi G, Ceulemans P, De Cuypere G, Van Laecke E et al. Phalloplasty: a valuable treatment for males with penile insufficiency. Urology 2008; 71: 272–276. 6 Garaffa G, Raheem AA, Christopher NA, Ralph DJ. Total phallic reconstruction after penile amputation for carcinoma. BJU Int 2009; 104: 852–856. 7 Massanyi EZ, Gupta A, Goel S, Gearhart JP, Burnett AL, Bivalacqua TJ et al. Radial Forearm Free Flap Phalloplasty for Penile Inadequacy in Exstrophy Patients. J Urol 2012; 190(4 Suppl): 1577–1582. 8 Jordan GH, Alter GJ, Gilbert DA, Horton CE, Devine CJ. Penile prosthesis implantation in total phalloplasty. J Urol 1994; 152: 410–414. 9 Ballaro A, Pryor JP, Ralph DJ. Prosthesis implantation after radial free flap phalloplasty in patient with bladder exstrophy. Int J Imp Res 1999; 11: 341–342. 10 Levine LA, Zachary LS, Gottlieb LJ. Prosthesis placement after total phallic reconstruction. J Urol 1993; 149: 593–598. 11 Hage JJ. Dynaflex prosthesis in total phalloplasty. Plast Reconstr Surg 1997; 99: 479–485. 12 Katz DJ, Stember DS, Nelson CJ, Mulhall JP. Perioperative prevention of penile prosthesis infection: practice patterns among surgeons of SMSNA and ISSM. J Sex Med 2012; 9: 1705–1712. 13 Fisch M, Wammack R, Ahlers J, Sennerich T, Müller SC, Hohenfellner R. Osseous fixation of a penile prosthesis after transsexual phalloplasty: a case report. J Urol 1993; 149: 122–125. 14 Perovic SV, Djinovic R, Bumbasirevic M, Djordjevic M, Vukovic P. Total phalloplasty using a musculocutaneous latissimus dorsi flap. BJU Int 2007; 100: 899–905. 15 Serefoglu EC, Mandava SH, Gokce A, Chouhan JD, Wilson SK, Hellstrom WJ. Long-Term Revision Rate due to infection in hydrophilic-coated inflatable penile prostheses: 11-year follow-up. J Sex Med 2012; 9: 2182–2186. 16 Wilson SK, Zumbe J, Henry GD, Salem EA, Delk JR, Cleves MA. Infection reduction using antibiotic-coated inflatable penile prosthesis. Urol 2007; 70: 337–340. 17 Silver RI, Yang A, Ben-Chaim J, Jeffs RD, Gearhart JP. Penile length in adulthood after exstrophy reconstruction. J Urol 1997; 157: 999–1003.
International Journal of Impotence Research (2015), 49 – 53
ORIGINAL ARTICLE
Inflatable penile prosthesis technique and outcomes after radial forearm free flap neophalloplasty RL Segal1, EZ Massanyi1,2, AD Gupta1, JP Gearhart1,2, RJ Redett3, TJ Bivalacqua1 and AL Burnett1 The aim of this study was to describe the technical aspects and short-term outcomes of inflatable penile prosthesis (IPP) implantation after neophallus reconstruction at a single institution. Nine men with previously constructed radial forearm neophalli underwent IPP implantation. The etiologies of their penile anomaly were bladder exstrophy complex in five, disorder of sexual differentiation in two and genital obliteration secondary to ballistic trauma in two. Median follow-up was 9.6 months (range 1.5–139.7). The records for these patients were retrospectively reviewed and outcomes recorded. Mean age was 23.6 (range 18–31) years, and mean time interval from neophalloplasty to IPP implantation was 22.1 months (range 3–48). In all cases, 3-piece IPPs were employed, with eight of patients having one cylinder implanted in the native corporal body and extending into the neophallus. Mean surgical time was 222 min (range 142–409). Median length of implanted device was 22 cm. No intraoperative complications were observed. At the most recent follow-up, six patients (66.7%) had functional devices, with acceptable surgical outcomes. Three patients (33.3%) sustained device infections, and three (33.3%) sustained cylinder erosion. In three patients in whom neo-tunica albuginea were fashioned by ensheathing the cylinder with allograft human dermal tissue matrix, no erosions occurred. One patient underwent two revisions, the first for the associated erosion and infection and the second for genital pain, and was left with a semi-rigid prosthesis. IPP implantation affords the best opportunity for functionality for patients with a radial forearm free flap neophallus. Caution must be taken to ensure viability of the neophallus intraoperatively, and protocols to minimize the risk of infection should be followed. Fashioning neo-tunica albuginea using graft material may reduce risk of erosion. International Journal of Impotence Research (2014) 27, 49–53; doi:10.1038/ijir.2014.30; published online 7 August 2014
INTRODUCTION As a result of evolving understanding of male genital anatomy and continued surgical ingenuity, men with severe genital anomalies or loss are able to experience successful sexual relationships. Men with congenital birth defects (aphallia, micropenis, classic bladder exstrophy/epispadias complex, cloacal exstrophy), ambiguous genitalia, a history of penile trauma resulting in penile destruction, a history of penectomy due to malignancy or female-to-male gender reassignment are now candidates for penile reconstruction, which allows the possibility of resumption of sexual activity. The most common tissue flap sources for neophallus reconstruction are free flaps derived from the radial forearm, but options also include tissue from the anterolateral thigh, the scapula/latissimus dorsi, fibula, and local rotational flaps from the abdomen, groin and thigh.1 The ultimate means to restore erectile function for these men involves implantation of a penile prosthesis. Although it is reported that men with a neophallus alone are able to engage in penetrative intercourse successfully,2 most reports of men with neophalli document the implantation of a penile prosthesis as the final step in the surgical reconstructive course.3–7 Although neophalli have an impressively natural aesthetic appearance (Figure 1), they are comprised solely of soft tissue, and thus they typically cannot generate the rigidity needed for penetration. The purpose of this study is to review our series, highlighting the technical aspects of contemporary inflatable penile prosthesis
(IPP) implantation in the neophallus. Although at our institution the preferred approach for neophallus reconstruction is to employ a radial forearm free flap, the features of IPP implantation discussed here are appropriate for neophalli derived from any tissue source. We also report on the outcomes of this surgery, and identify comorbid factors that influence surgical success. MATERIALS AND METHODS Data accrual After obtaining institutional review board approval, a database of all patients undergoing implantation of a penile prosthesis at our hospital from 1 January 2000 to 31 December 2011 was retrospectively compiled. Patients were identified on the basis of querying the GE Centricity Professional Fee Billing System for Current Procedure Terminology (CPT) procedure codes from hospital records, and all pertinent information was collected from the electronic medical record and transferred into a computerized database. A total of nine patients were identified with previous radial forearm neophallus reconstruction who underwent IPP implantation (performed by TJB and ALB).
Data collection Variables collected included patient demographic parameters, medical comorbidities, details of the surgery (date, surgeon, duration of surgery [time from anesthesia induction to the patient’s transfer out of the operative suite], perioperative antibiotics employed, mode of anesthesia
1 The James Buchanan Brady Urological Institute, The Johns Hopkins Medical Institutions, Baltimore, MD, USA; 2Division of Pediatric Urology, The Johns Hopkins University School of Medicine, Charlotte Bloomberg Children's Hospital, Baltimore, MD, USA and 3Department of Plastic and Reconstructive Surgery, Johns Hopkins School of Medicine, Baltimore, MD, USA. Correspondence: Dr AL Burnett, The James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions, 600 North Wolfe Street, Marburg 407, Baltimore, MD 21287, USA. E-mail: [email protected] Received 10 September 2013; revised 13 May 2014; accepted 26 June 2014; published online 7 August 2014
IPP after neophalloplasty RL Segal et al
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Figure 2. Appearance of neophallus before IPP implantation. Arrow indicates position of native glans exposed at the ventral base of the neophallus.
Figure 1.
Appearance of a neophallus before IPP implantation.
employed, duration of hospitalization), surgical outcomes (infection, erosion [defined as physical extrusion of any component of the device through either skin or urethra] or mechanical failure [defined as any circumstance where the patient is not satisfied with the operability of the device, which requires surgical revision]) and clinical follow-up. For this study, follow-up consisted of outcomes noted in their most recent hospital clinic visit.
Description of surgery Penile prosthesis implantation in a reconstructed neophallus is a technically demanding surgery, for which the surgical approach has previously been described.8–11 Our approach is similar, and will be described now. As for men with native phalli, patients are treated perioperatively with antibiotics, and all the same precautions to mitigate the risk of infection are taken.12 General anesthesia is employed, and patients are placed either in supine or low lithotomy position, depending on the underlying etiology of the patient’s penile anomaly and the extent of reconstruction that will be required. Men with native corporal bodies, such as those with bladder exstrophy, may be approached similarly to men with native phalli with a penoscrotal approach. For those who had not undergone neocrura reconstruction as part of their phalloplasty, prosthesis fixation is required to ensure its stability, which may be feasibly performed through a penoscrotal incision. Conversely, patients with neocrura derived from synthetic materials should be positioned in low lithotomy, so that perineal access to the proximal aspect of the neocrura is possible. Appreciation of the anatomy of the neophallus is critical. It is advisable to have the reconstructive surgeon who performed the phalloplasty available should his expertise be required. If a diminutive native phallus is incorporated into the neophallic reconstruction (most commonly at the phallic base) to preserve erogenous sensation, its presence should be noted (Figure 2). The position of the neophallic arterial supply should be documented with intraoperative Doppler ultrasound. If the neophallus was reconstructed with a neourethra through which voiding occurs, it should be gently catheterized so that the position of the urethra is notable at all times. Additionally, consideration should be taken for suprapubic catheter urinary diversion so that the urethral catheter may be removed as soon as possible postoperatively to limit the duration of the foreign body’s presence within the neourethra and risk of tissue breakdown. If the patient is already surgically diverted via catheterizable stoma, this stoma should be catheterized to monitor urine output during surgery, but the catheter may be removed afterwards so that the patient is able to resume selfcatheterization. International Journal of Impotence Research (2015), 49 – 53
Figure 3.
Proximal corporal dilation with a Hegar dilator.
If a penoscrotal incision is to be used, careful dissection to expose the native corporal bodies is the initial surgical step. This portion of the procedure may be challenging, particularly when the corporal bodies are diminutive. Once identified, the surgeon must determine whether it is possible to implant two cylinders, based on the girth of the neophallus. Although the presence of two cylinders may achieve symmetry, the neophallus may not be able to accommodate them suitably when fully inflated, in which case one cylinder is preferred. If one cylinder is to be implanted, then the more stout corporal body should be selected for implantation, though the location of the neophallic blood supply may influence this decision. A corporotomy is made, and proximal dilation to the crus is performed (Figure 3). Distal dilation is performed, and the corporal body is carefully perforated anterolaterally through the dorsal tunica albuginea, allowing the dilator to pass into the neophallus. This maneuver is critical, as corporal perforation too medially at the dorsal aspect of the native phallus may injure its dorsal penile nerve and compromise erogenous sensation. Neophallic dilation is performed, and the phallic length is measured. The appropriately sized IPP is selected (Figure 4), and depending on the girth of the neophallus, slender cylinder(s) (such as the AMS 700 CXR (Minnetonka, MA) or Coloplast (Minneapolis, MN) narrowedbased) may be used. In order to provide additional protection against cylinder erosion, the surgeon may elect to cover the distal cylinders with a sleeve of graft material, either allograft or xenograft, which serves as an extra layer ensheathing the IPP cylinders. If so, the dimensions are measured and the graft material is folded into a cylinder and the edges sutured together (similar to a cigar in a cigar tube). This cylindrical sleeve is then applied © 2014 Macmillan Publishers Limited
IPP after neophalloplasty RL Segal et al
51
Figure 4.
Table 1. Patient
Appearance of neophallus with a single cylinder implanted, before scrotal pump positioning.
Preoperative patient characteristics Age (years) at time of IPP implantation
1 2 3 4 5 6 7 8 9
20 20 23 27 31 22 25 18 26
Diagnosis
Phalloplasty procedure
CBE, penile inadequacy CBE, penile inadequacy CBE, penile inadequacy, epispadias Genital trauma-penile loss DSD Genital trauma-penile loss Cloacal exstrophy, penile inadequacy CBE, penile inadequacy, epispadias DSD
MRFFFP MRFFFP MRFFFP MRFFFP N/A MRFFFP MRFFFP MRFFFP MRFFFP
(left) (left) (left) (left) (left) (left) (right) (left)
Time from phalloplasty (months) 9 19 19 48 3 25 17 11 48
Abbreviations: CBE, classic bladder exstrophy; DSD, disorder of sexual differentiation; MRFFFP, microvascular radial forearm free flap phalloplasty; N/A, not applicable.
over the IPP cylinder(s), which are then implanted routinely. Corporotomy closure is then performed. Given that most of these patients have had previous lower abdominal or inguinal surgeries, ectopic reservoir implantation is generally employed. The scrotal pump is placed routinely in a subdartos pouch. For men with prior constructed neocrura, ideally the cylinders should be positioned within them so that the cylinders are anchored and will not move within the neophallus. Depending on their proximal extent, the neocrura may be accessed via a perineal approach. Dilation is then performed within these neocrura, and the cylinders are positioned within them. For men without either native crura or neocrura, the IPP needs to be anchored to ensure its stable position within the neophallus. IPP anchoring may be accomplished by its osseous fixation to the pubic symphysis13 or inferior pubic rami,14 by suturing the rear-tip extender directly to the bone, or by placing the cylinders within cylindrical sheathes of graft material constructed as neocrura.8–10
Clinical protocol Patients are kept in hospital for observation for typically one night, and discharged home on postoperative day 1. The scrotal drain is removed when drainage has reached a nadir. Follow-up consists of a clinic visit at least 6 weeks postoperatively to verify postoperative recovery and to instruct the patient on pump © 2014 Macmillan Publishers Limited
manipulation. The most important aspect of this instruction is to ensure that the patient is proficient with the deflation mechanism to avoid tissue necrosis effects that result in cylinder erosion associated with partially inflated devices. Sensation in the neophallus may be incomplete, however, and patients may not experience the same discomfort as a warning to deflate the device circumventing cylinder erosion.
RESULTS Patient baseline preoperative characteristics are listed in Table 1. Of the nine patients, eight underwent neophalloplasty at our institution, derived from radial forearm free flap, at a mean of 22.1 (range 3–48) months prior to IPP implantation. The etiology of penile anomaly was bladder exstrophy complex in four, cloacal exstrophy in one, disorder of sexual differentiation in two, and genital loss secondary to ballistic trauma in two. Mean age at the time of IPP implantation was 23.6 (range 18–31) years. Median body mass index was 26.5 kgm − 2. Eight out of nine patients had no previous attempts at IPP implantation. One patient previously had a semi-rigid prosthesis with which he was not satisfied, which prompted IPP implantation at another institution. This device International Journal of Impotence Research (2015), 49 – 53
IPP after neophalloplasty RL Segal et al
International Journal of Impotence Research (2015), 49 – 53
IPP salvaged 14 No Yes 409 Yes
Functional IPP — No 162 Yes
9
Abbreviations: IPP, inflatable penile prosthesis; N/A, not applicable.
18 AMS 700 CXR
AlloDerm sheath encasing IPP cylinders AlloDerm sheath encasing IPP cylinders 22 AMS 700 CX 8
AMS 700 CX
Infrapubic; 2nd incision for reservoir; 3rd incision for pump Penoscrotal; 2nd incision for reservoir Penoscrotal; 2nd incision for reservoir 7
12
No
Functional IPP — No No 173
No Yes N/A
Proximal Windsock (Tutoplast Yes pericardium) anchored to native CB AlloDerm sheath encasing IPP Yes cylinders 24 Mentor Alpha I Lateral Penoscrotal 6
4 5
3
2
14
Functional IPP Replaced with semi-rigid prosthesis, which also eroded, not replaced IPP salvaged; Eventually replaced with semi-rigid prosthesis — 50 AMS 700 CX AMS 700 CX
27 24
None None
Yes Yes
N/A 288
No No
No Yes
Functional IPP — None 15
No
183
No
No
IPP explanted and not replaced 288 Yes Yes 202 No None 12
AMS 700 CXR AMS 700 CX
141 Yes No 142 No None AMS 700 CX
Lateral penoscrotal; 2nd incision for reservoir Infrapubic; 2nd incision for reservoir Penoscrotal; 2nd incision for reservoir Penoscrotal Penoscrotal 1
22
Drain (yes/no) Total IPP Adjuvant maneuvers length (cm) IPP type Patient Surgical approach
Surgical procedures and outcomes
Table 2.
DISCUSSION As demonstrated in this study, IPP is feasible in neophalli. However, although effective at restoring erectile function with satisfactory outcomes, IPP implantation in men with neophalli is associated with greater risk of complications than in men with normal native phalli. Risks of device infection and erosion (both 33.3%) were shown to be considerably higher than those reported in the contemporary standard phallic IPP literature (1–8%).15,16 The main emphasis of this report is to highlight the surgical principles of IPP implantation in a neophallus. These include (i) initial identification of critical structures, including the vascular supply of the neophallus, and the neourethra (if present), to ensure safety and prevent iatrogenic injury; (ii) anchorage of the prosthesis within the native corporal body or to the surgically reconstructed neocrura, depending on the underlying etiology of penile loss; (iii) cylinder ensheathment with a sleeve of graft material to mitigate against percutaneous neophallic cylinder erosion. This last point is of particular importance, because early in our series, three out of six (50%) patients did not undergo this step sustaining subsequent cylinder erosion, whereas this modification later resulted in no patient sustaining erosion. Other considerations in the context of managing erosion, such as downsizing the cylinder(s) or primary neophallic repair, while possible, result in our opinion in suboptimal outcomes, such as destabilization of the erect neophallus or further risk of device infection, respectively. As such, preventing erosion from occurring altogether should be
Surgical time Infection Erosion Time to adverse Outcome (min.) event (days)
subsequently became infected which was explanted at our institution 8 months prior to IPP re-implantation. The surgical details for each patient are listed in Table 2. Surgical approaches were either penoscrotal or infrapubic, with this decision based on what was thought to be the most direct access to the corporal bodies, as well as the lowest risk to the vascular supply to the neophallus. All patients had one cylinder implanted, except patient #9, who had two. Given the extensive previous surgical history of the majority of these patients, a counter-incision in the lower abdomen was made for reservoir placement in six patients, with one patient requiring an additional scrotal incision for proper pump placement. Four patients had adjuvant maneuvers to optimize positioning of the cylinders within the neophallus, including a proximal windsock derived from allograft pericardium in one patient, and acellular human dermis allograft neotunica construction for the neophallus in three patients. Mean operative duration was 222 min (range 142–409). Median follow-up was 9.6 months (range 1.5–139.7). Three out of nine (33.3%) patients developed infections of their IPP, one with associated device erosion through the distal tip of the neophallus, and two developed wound breakdown with exposure of underlying device components (Table 2). Two patients developed distal cylinder erosion through the neophallus without associated clinical infection, for an erosion rate of 33.3% (3/9). In one of those cases (patient #1), it was noted that the IPP was never fully deflated, which presumably explains the cause for erosion: chronic pressure within the neophallus from the inflated IPP cylinder resulting in distal ischemia and eventual erosion. In the two patients with wound separation, the indwelling IPP was salvageable with washout and secure wound closure. In one of these patients, as a result of chronic genital pain, the IPP was eventually removed and replaced with a semi-rigid prosthesis, 7 years later. The combined complication rate (erosion or infection or both) was five out of nine (55.6%). No patient had mechanical functional failure of the device. At the last follow-up, six patients possess stable, intact devices, and one out of six (16.7%) is sexually active by report. No explicit reasons were given as to why those five out of six patients with intact devices are not sexually active.
IPP explanted and not replaced
52
© 2014 Macmillan Publishers Limited
IPP after neophalloplasty RL Segal et al
53 striven for, which in our mind is best accomplished by cylinder ensheathment. Multiple reports have documented the feasibility, safety and success of penile prosthesis implantation in a neophallus. Hoebeke et al.3 reported on 35 gender reassignment patients, of whom 10 received semi-rigid and 25 received inflatable devices. Successful implantation occurred in all 10 patients receiving a semi-rigid device, although 1 patient underwent revision to have a 3-piece IPP implanted. In the IPP group, complications (infection, neophallus necrosis and/or erosion) occurred in five patients (20%). In a report with longer-term follow-up from the same group, with 120/129 gender reassignment patients receiving 3-piece IPPs, there was a 41.1% risk of surgical removal or revision of the prosthesis at a mean follow-up of 30.2 months for device infection, erosion or malfunction.4 Of all IPPs used in this cohort, 108/185 (58.4%) still remained in place after initial implantation, with a total infection rate of 11.9%, erosion rate of 8.1%, prosthesis malfunction rate of 22.2% and malposition rate of 14.6%. Bettocchi et al.2 reported that among 17 patients with neophalli who underwent penile prosthesis surgery, 6 of 8 receiving semirigid prostheses sustained erosions. Perovic14 reported successful penile prosthesis insertion in eight men (three IPP; five semi-rigid) with a variety of penile anomalies without complication. Lumen5 reported that in men undergoing neophallus reconstruction, two out of four men required penile prosthesis explantation because of infection. In Garaffa’s6 series of men undergoing neophallus construction status post penile carcinoma treatment, four out of five men had successful IPP implantation, with one device explanted as a result of infection. Special consideration should be given to men with classic bladder exstrophy or cloacal exstrophy. Anatomical distortions of the pelvis, namely diastasis of the symphysis pubis, as well as the native penis, most notably a shorter anterior corporal segment (distal from the pelvic attachment), and a greater intercorporal distance,17 may contribute to a heightened risk of complications associated with IPP implantation in a neophallus. With angulated proximal support, the position of the cylinder may deviate oppositely within the neophallus. We postulate that this contributes specifically to the risk of erosion for IPP in neophalli, reported here and elsewhere.7 This complication occurred because of incomplete deflation of the cylinder, which exerted lateral pressure at the distal neophallus. Counseling is critical for the patient to fully understand these risks and adhere to instructions for device use to try to mitigate them. For men with neophalli, preoperative counseling about risk of adverse events and realistic outcome expectations is critical for both patient understanding and medicolegal considerations. Should any surgeries, either aesthetic or functional, be required on the genitalia (including but not limited to neophallic revision for any reason, tattooing, urethroplasty or scrotoplasty), these should be completed prior to penile prosthesis implantation. This sequence is recommended because any post-prosthesis surgical intervention may result in inadvertent damage to the device, or may cause exposure of device components, which will increase the risk of prosthetic infection. Of additional importance is consideration for scrotoplasty. For IPPs, the pump is routinely placed within the scrotum for easy pump manipulation. As such, for proper surgical planning, the scrotum must be adequately sized to accommodate the pump within a subdartos pouch. Although placement is often easily achieved even in men with diminutive scrota (such as post-trauma, post-scrotectomy or possibly femaleto-male transgender patients), any plans for scrotal enhancement surgery, whether in the form of grafting or tissue expansion, should be pursued prior to penile prosthesis implantation. Ectopic pump placement has not been reported, and in the situation where the size of the scrotum limits pump placement, the patient may have to assume the inherent risks of a semi-rigid prosthesis. IPPs generally
© 2014 Macmillan Publishers Limited
are preferred over semi-rigid prostheses to limit constant pressure within the neophallus, which may predispose to cylinder erosion, described above. Special attention should be given to arterial blood supply to the flap to avoid its disruption, which can result in ischemia, necrosis and loss of the neophallus, the most dreaded outcome of penile prosthesis implantation. If it is felt that during surgery survival of the neophallus may be jeopardized, then a decision to abort prosthesis insertion may be necessary. Once the surgery is complete, the patient must allow for an extended period of recovery for healing. Our report has some potential limitations. Our series represented a small number of patients, with limited follow-up. This reflects the relative novelty of undertaking this surgery at our institution, as well as the fact that our cohort includes two-thirds international patients for whom routine follow-up is extremely difficult. Finally, we did not formally assess patient satisfaction or quality of life outcomes associated with their surgery. In conclusion, implantation of IPP in men with reconstructed neophalli is complex and should only be undertaken by experts, with the understanding that surgical plans depend on the etiology of the native penile anomaly and anatomic constraints of the neophallus. Risk of adverse events is considerably higher in this patient population, and informed consent is critical. Nevertheless, successful surgical outcomes may be achieved. CONFLICT OF INTEREST The authors declare no conflict of interest.
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