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F. E. Martins et al. (eds.)Textbook of Male Genitourethral Reconstructionhttps://doi.org/10.1007/978-3-030-21447-0_48

48. Management of Non-infectious complications during and after Inflatable Penile Prosthesis Placement

Jonathan Clavell-Hernández¹, Rafael Carrion² and Run Wang^{3, 4}

(1)

St Joseph Medical Center, Houston, TX, USA

(2)

University of South Florida, Tampa, FL, USA

(3)

Division of Urology, University of Texas Health Science Center-McGovern Medical School, Houston, TX, USA

(4)

Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA

Run Wang

Email: run.wang@uth.tmc.edu

Keywords

Penile prosthesisErectile dysfunctionSurgical complicationsCorporal crossoverCorporal perforationCylinder erosionFloppy glansAuto-inflationGlans hypermobilityReservoir complication

48.1 Introduction

Penile prosthesis implantation has been proven to be an effective management approach for medically refractory erectile dysfunction (ED). The inflatable penile prosthesis (IPP) is among the most reliable medical devices currently in use with over a 95% 5-years survival, 80% 10-years survival and over 70% 15-years survival [1]. In the hands of an experienced surgeon, the surgery offers a high patient satisfaction rate and a low rate of complications. This relationship between patient outcomes and surgical volume has been well documented for IPP placement [2]. Given that most urologists who perform fewer than five implants per year are responsible for more than 75% of penile prosthesis placement in the United States and United Kingdom [3, 4], awareness of intraoperative and postoperative obstacles is pivotal. Moreover, every surgeon should be prepared and know how to troubleshoot these complications.

The goal of this chapter is to present the most common non-infectious complications during and after IPP surgery and provide ways to avoid and work through these problems in order to increase patient satisfaction. The prevention and management of infection after IPP placement will not be discussed in this review.

48.2 Intraoperative Complications

The best approach to complications during surgery is always prevention. Careful preparation prior to surgery and understanding all possible issues that may arise is crucial.

48.2.1 Corporal Dilation

Penoscrotal and infrapubic approaches are highly effective for smooth implantation. Ultimately, the decision for which approach to use is left to the discretion of the surgeon and is often dictated by familiarity and previous training. Regardless of the surgical approach chosen to place the implant, adequate exposure of the corpora is paramount. The corpora cavernosa should be accessible and visible without any overlying tissues, and the corporotomies should be properly sized. A corporotomy that is too small can cause difficulty during dilation and placement of the cylinder base, while larger corporotomies can cause an incompletely closed corporotomy. This can increase the risk for bleeding/hematoma formation and cause an unintended damage to the cylinder while trying to reinforce the closure. Dilation is usually done with the use of Hegar or Brooks dilators. Hegar dilators have the disadvantage that the entire length of the instrument is the same diameter which may create higher resistance, while Brooks dilators have a bullet configuration on the end that creates less resistance. The steel stem of the Brooks dilator is also in a “Z” configuration which can make the dilation passes easier. During distal dilation, dilators should always be angled dorsolaterally to avoid urethral injury and proximal dilation should be performed taking into consideration the lateral route of the proximal crura.

It is helpful to consider the minimal diameter required for the cylinders available during implantation. Boston Scientific’s AMS (American Medical Systems) 700 CXR and Coloplast Narrow Base cylinders only require dilation to 9 mm. AMS CX and LGX require dilation of 11 mm, while Coloplast’s Titan cylinders require dilation to 11 or 12 mm proximally and 9–10 mm distally. While most prosthetic surgeons perform corporal serial dilations for virgin IPP cases, Moncada et al. suggested that dilation is not necessary during IPP placement. One hundred patients were randomized to penile implantation with vs without prior dilation of the corpora cavernosa. The patients who did not undergo dilation underwent IPP placement with the Furlow device (9 mm diameter) which was only used for measurement and placement of the cylinders. Although the clinical significance of their findings is questionable, the study showed no difference in complication rates, but a statistically significant increase in flaccid penile length along with decreased OR time and postoperative pain in the non-dilated group [5]. Despite which surgical technique is undertaken it is imperative to ensure proper cylinder placement to avoid patient dissatisfaction (Fig. 48.1).

../images/468369_1_En_48_Chapter/468369_1_En_48_Fig1_HTML.png — Fig. 48.1

Flail penis as a result of difficult dilation during penile prosthesis implantation. (Dr. R Carrion, USF Health)

48.2.2 Corporal Crossover

Dilation of the corpora during IPP placement has been reported as a challenging step for the delayed occurrence of complications [8]. When two cylinders end up within the same corporal body either proximally or distally, one has crossed over the midline. The septum of the corporal bodies is fenestrated and lends itself to violation during instrumentation. The best approach to prevent crossover is to always keep in mind the dorsolateral angle during corporal dilation. Indicators for corporal crossover include contact during simultaneous dilation, unequal corporal measurements, difficulty with placement of the second cylinder, misalignment of the urethral catheter off midline between the two inflated cylinders, and a lopsided, unusual erection upon cylinder inflation [6, 7]. Cylinder crossover will result in penile deformity or shortening and the development of a fibrous capsule around the implant that will require additional surgical intervention to correct. It is important to be able to identify and correct this at the time of surgery to avoid having the patient complain during his postoperative visit of de novo angulation or persistent pain in the penis upon inflation of the cylinders.

Distal crossover probably occurs more frequently in infrapubic placement of cylinders. If the penis is not on stretch, and the surgeon is not careful, it is quite easy to pass the Furlow needle-introducer device over the opposite side and back to the same side before firing the needle through the glans penis. Distal cylinder crossover can be very subtle at the time of surgery but can be obvious after a few months. (Fig. 48.2) In the intraoperative setting, this is usually easily remedied. Remove both cylinders, place a dilator in the common cavity that receives the crossover, re-dilate the opposite cavity being sure to dilate laterally with the tip indenting the skin outward. Next, pass the Furlow needle-introducer device, and while maintaining the dilator in the “crossover” side, the first cylinder is placed. Finally, you remove the dilator and pass the Furlow on the side originally holding both cylinders and place the second cylinder [6].

../images/468369_1_En_48_Chapter/468369_1_En_48_Fig2_HTML.png — Fig. 48.2

(a) Distal crossover with lateral droop of the glans. (b) Distal crossover with de novo penile angulation. (Dr. R Carrion, USF Health)

Proximal corporal crossover is caused by corporal fibrosis and technical errors. A proximal crossover is suspected when the first cylinder base has passed through the septum, occupies the contralateral corpora, and the surgeon has difficulty placing the base of the second cylinder. This technical error can occur when the surgeon does not respect the natural lateral divergence of the proximal crura during dilation. Similar to distal crossover, proximal corporal crossovers are managed by placing a dilator in the normally dilated corporal side. A second dilator is then passed proximally into the contralateral corpora and a clinking metal sound confirms the crossover. If this happens, the surgeon should reposition the dilator laterally to create a more lateral plane. When the handles of the dilators look like an American football field goal post, successful correction of the crossover has ensued [9] (Fig. 48.3).

../images/468369_1_En_48_Chapter/468369_1_En_48_Fig3_HTML.jpg — Fig. 48.3

Brooks dilators placed within each proximal corpora. Dilators are at the same length and resemble an American Football field goal post, demonstrating correction of proximal crossover. (Dr. R. Wang, UT/MDA)

48.2.3 Proximal or Crural Perforation

Another well-known intraoperative complication is tunical perforation-injury during proximal dilation. This usually occurs in patients with corporal fibrosis. When the corporal body is scarred, there is a tendency to dilate forcefully downward which may lead to perforation. Like corporal crossover, if proximal perforations go unrecognized, problems may arise postoperatively. The cylinder will eventually migrate through the perforated window and the distal end of the cylinder will be felt in the midshaft. (Fig. 48.4) One way to prevent this complication is by avoiding the use of narrow (<9 mm) caliber dilators [10]. Traditionally, a perineal incision was made to repair the defect. Repair involved repositioning the patient into the lithotomy position, and a complicated closure or a graft ‘windsock’ placed around the base of the cylinder which was fixed to the adjacent corporal tissue. However, due to its complexity and high rate of postoperative infection when synthetic graft material is used, direct closure of the perforation is not advised [11, 12].

../images/468369_1_En_48_Chapter/468369_1_En_48_Fig4_HTML.png — Fig. 48.4

Proximal perforation (a) Left proximal perforation. Patient complained of pain while sitting down. RTE was palpable on digital rectal exam. (b) Migration of left cylinder with tip at the mid shaft. (Dr. R Carrion, USF Health)

In order to avoid closure of the defect, experts have adopted methods to keep the cylinder base from migrating down through the defect and allow the perforation to scar over the base of the cylinder. Wilson described the use of the rear tip extender (RTE) sling that addressed the perforation without the use of graft material [13]. First, the non-perforated side is measured and will determine the total length of the cylinder and rear tip extender of the affected side. A non-absorbable suture (00 Prolene) is placed through the lateral tunica albuginea wall at the level of the corporotomy, passed through the proximal end of the RTE, and then passed through the medial corporotomy wall. (Fig. 48.5a) Cylinders are then implanted in standard fashion and the corporotomies are closed. The guide sutures exiting the glans are held on tension to ensure the RTE is not extending through the perforation tunnel. With the prosthesis fully inflated, the suture sling is tied and acts as a hammock, keeping the cylinder base from sliding proximally. After surgery, the development of fibrous scar tissue will encase and fix the cylinder into place. Another maneuver used to prevent proximal migration is to fixate the input tubing with the stay sutures at the level of the corporotomy. (Fig. 48.5b) In order to allow time for the fibrous capsule to form, patients are advised to avoid sexual intercourse for at least 6 weeks postoperatively [11].

../images/468369_1_En_48_Chapter/468369_1_En_48_Fig5_HTML.jpg — Fig. 48.5

(a) RTE sling which serves as a hammock to keep the proximal edge of the cylinder from migrating through the perforation. (b) While the cylinder is being pulled by the string exiting the glans, the corporotomy stay sutures are tied around or below the tubing exiting the cylinder in the perforated side to avoid proximal migration

48.2.4 Distal Perforation

Distal perforation may occur during dilation of the corporal body or during penile modeling to correct Peyronie’s disease [11]. This can be avoided by isolating the urethra by firmly squeezing the glans immediately proximal to the glans during dilation in an infrapubic approach and during manual modeling for Peyronie’s disease [14]. Indicators of distal perforation include seeing blood, dilator or the tip of the cylinder at the urethral meatus. (Fig. 48.6) Confirmation of urethral perforation is usually obtained by noticing a rush of fluid from the meatus after injecting irrigation fluid into the corporotomy. The safest course is to abort the surgery, address the urethral injury, and consider IPP re-implantation 2 or 3 months later. If the penile prosthesis is implanted, leaving cylinders adjacent to an unrepaired urethral injury increases the risk of implant infection and impaired wound healing.

../images/468369_1_En_48_Chapter/468369_1_En_48_Fig6_HTML.jpg — Fig. 48.6

Urethral perforation . Distal tip of cylinder is visualized within the urethral meatus. (Dr. R. Wang, UT/MDA)

A distal urethral injury should be evaluated and assessed for the need for primary closure. Small distal urethral injuries may heal without repair. Prolonged catheter placement is usually not necessary given that the urinary stream will draw tissue fluid into itself from the perforation rather than allow urine to infiltrate the corporal cavity [7]. However, larger injuries typically require repair and an adequate exposure for a 2-layer closure. A single cylinder may be placed in cases of unilateral urethral injuries that are adequately repaired [6]. However, one must take into consideration that patient satisfaction with a single inflatable cylinder is considerably lower than with two cylinders [6].

More recently, some surgeons have adopted ways to avoid aborting prosthesis implantation after distal urethral injuries. Anele et al. [15] published a series of 4 urethral injuries out of 243 patients who underwent primary urethral repair and temporary suprapubic cystostomy allowing for successful completion of unaborted IPP implantation. Urinary diversion with suprapubic tube (SPT) was maintained for 4–8 weeks to allow for urethral healing. After 6 months follow-up, there were no reports of infection, erosion or mechanical failure. Another option that is rarely utilized for distal urethral/meatal injuries is to create an iatrogenic hypospadias in order to access the urethral perforation. Once a two-layer closure of the urethral perforation is performed, the IPP cylinders are implanted and a 14-Fr foley catheter is left in place for 3–5 days. The goal is that the hypospadiac meatus minimizes the pressure differential between the urethral catheter and the corporal cylinder by allowing the urine to exit proximal to the injury. The author of this technique recommends to avoid prosthesis cycling and sexual intercourse for 6 weeks to avoid re-perforation [16].

48.2.5 Intraoperative Reservoir-related Injuries

When placing an IPP through a penoscrotal approach , reservoir placement is performed blindly, which can be stressful for some surgeons. The goals to favorable reservoir placement include preventing the patient from feeling or seeing the reservoir, preventing autoinflation, and limiting any other more serious complications such as injury to bladder, bowel or vessels. It is important to note that reservoir-related complications are relatively rare in the hands of an experienced surgeon. However, a complication during placement of a reservoir can make a relatively easy operation become a disaster. Penile prosthesis reservoirs have been traditionally placed in the prevesical space, or Space of Retzius (SOR) , below the abdominal wall fascia. Levine and Hoeh presented their technique of traditional reservoir placement in the SOR to avoid creating inguinal floor weakness and visceral injury [17]. In their technique, Jorgensen scissors are used to pass through the penoscrotal incision, inguinal ring and over the pubis with the tips pointing posteriorly to perforate the transversalis fascia and gain access to the retropubic space. This allows the surgeon to insert their finger in the SOR and create space to place the reservoir.

A study in 2013 showed that there was a rising concern among surgeons when placing an IPP reservoir in patients after robotic-assisted laparoscopic prostatectomies (RALP) [18]. RALP require an intraperitoneal approach and robotic surgeons do not re-establish the peritoneal veil in the pelvis which allows the bowel to migrate to the prevesical space. Given that the number one indication for IPP placement is post-prostatectomy ED [7], the surgeon must take into consideration that the prevesical space may have excessive scar. Therefore, blind placement of the reservoir from a penoscrotal incision into the SOR can lead to catastrophic injuries which include bladder, small bowel injury, small bowel obstruction and intestinal fistula [19, 20].

To avoid incurring these risks, surgeons have proposed the use of an alternative or ectopic location. Ectopic location involves reservoir placement between the transversus abdominis muscle anteriorly and the transversalis fascia posteriorly, rectus abdominis muscle anteriorly and transversalis fascia posteriorly, or subcutaneous below the Scarpas fascia [7, 21, 22]. While some use ectopic reservoir placement for patients with history of pelvic surgery, others have adapted and used this approach routinely [23, 24]. To do this, the index finger is placed through the external inguinal ring on top of the transversalis fascia and a space is created pointing to the ipsilateral shoulder. This space is then broadened and extended toward the shoulder using a ring clamp. Both the AMS Conceal™ low profile reservoir and Coloplast Cloverleaf® reservoir provide a ‘flat-like’ configuration that avoids palpation of the reservoirs when placed ectopically. Nevertheless, ectopic reservoir placement (ERP) has its own array of complications. We will briefly discuss complications that can occur during traditional SOR and ectopic placement of reservoirs. Table 48.1 summarizes the largest series reporting complications related to reservoir placement.

In a cadaver study, Henry and colleagues showed that a full bladder may be as close as 2 cm to the inguinal ring, while 6.75 cm while decompressed [25]. Therefore, the best way to avoid a bladder injury is to ensure that the bladder is empty prior to implantation of the reservoir. Various case reports have been published on patients with bladder perforation [26–31]. The largest series was reported by Furlow and Goldwasser who found erosion of the reservoir in a total of eight patients, six cases into the bladder and 2 cases into an ileal conduit (0.4%) [26]. Risk factors for visceral erosion include prior pelvic surgery and radiation. Patients with bladder erosion usually present with either gross hematuria or irritative voiding symptoms (Fig. 48.7) [27, 28]. A cystoscopy or imaging studies will confirm injury and depending on the extent of injury, the bladder defect should be repaired or a Foley catheter/suprapubic tube should be left in place until the bladder injury is healed.

../images/468369_1_En_48_Chapter/468369_1_En_48_Fig7_HTML.jpg — Fig. 48.7

Erosion of prosthetic reservoir within bladder which is noted as a filling defect within the bladder. (Dr. R Carrion, USF Health)

Bowel injuries during or after reservoir placement are extremely rare. Documented cases have presented with small bowel obstruction and intestinal fistula [19, 20].

Management of a bladder injury may be addressed without removal of the penile prosthesis. If the reservoir has eroded into the bladder, the reservoir may be removed with subsequent repair the bladder laceration and the reservoir can be relocated in the other side of the pelvis or in an ectopic location. On the other hand, bowel injury is more complex to manage. There are no studies of the proper management of this type of injury since it is extremely rare. Mulcahy recommends extension of the incision or a new incision to visualize the injury, resection of the involved bowel part and anastomosing the two bowel segments, while repositioning the reservoir elsewhere with copious wound irrigation [7].

The iliac vessels are about 3 cm lateral to the pocket where the reservoir is traditionally placed [25]. The vessels most commonly injured are the external iliac vein or branches such as the inferior epigastric, external superficial pudendal or cremasteric vessels. These vessels can be injured during placement or removal of retropubic reservoirs [17]. If copious bleeding is noted, vascular injury should be suspected, and the first step should be to ensure adequate exposure. Either the original incision is extended or a new incision should be made and the surgeon should consider an intraoperative consultation to a vascular surgeon who can aid with injury repair, if necessary. On many occasions, the surgeon removing the reservoir is different than the original surgeon who placed the initial implant. These situations can increase the risk of bleeding during reservoir removal which has led some surgeons to decide to leave the reservoir behind in uninfected IPP revisions (Fig. 48.8) [32, 33]. There have also been several reports of reservoir compression to the external iliac vein with subsequent lower extremity edema and deep venous thrombosis [17, 34–38]. If a traditional-SOR approach is undertaken, vascular complications can be avoided by ensuring that an adequate space has been created such that there is no compression to the adjacent venous structures. Whenever inadequate space is encountered, the surgeon should consider ERP.

../images/468369_1_En_48_Chapter/468369_1_En_48_Fig8_HTML.jpg — Fig. 48.8

Prosthetic reservoir in the pelvis adjacent to the bowel and iliac vessels. Extreme caution to surrounding structures should be taken during reservoir removal to avoid injury. (Dr. R. Carrion, USF Health)

48.3 Postoperative Complications

Although there have been dramatic breakthroughs and improvements in prosthesis design and implantation techniques over the years to decrease complications rates and improve durability and patient satisfaction, the principles in IPP placement remain well-established.

48.3.1 Hematoma

Bleeding and hematoma formation may contribute to postoperative complications following IPP placement. Hematomas typically develop in the scrotum which provides a substantial expansion for blood and other fluids to collect. One common source of hematoma formation is bleeding from the corporotomies. Utilizing stay sutures or running horizontal mattress sutures during closure of the corporotomies may reduce the risk of hematoma formation [39]. While hematomas are not devastating relative to other complications and may be managed conservatively, they may become problematic in the postoperative setting because they may cause scrotal pain, discomfort, and an increased length of observation or repeat office visits. In the literature, incidence of postoperative hematoma after penile prosthesis placement ranges from 0.2% to 3.6% [40–46]. In a study by Pozza and colleagues, an incidence of 22% was reported after their first 50 prostheses without the use of closed suction drainage (CSD) . However, after incorporation of CSD, their overall hematoma formation rate after a total of 500 cases was 3.6% [40]. Table 48.2 summarizes the incidence and management of several series reporting postoperative hematoma.

Table 48.2

Studies regarding outcomes and management of hematoma formation

Author	Year	Study population	Follow-up	Study design	Hematoma rate	Drain vs no drain hematoma rates	Management	Comments
Pozza et al. [40]	2015	500	NR	Retrospective	3.6%	SRPP (0.4%) IPP without CSD (22%) IPP with CSD (5.6%)	Needle aspiration and observation.	Study included Semi-rigid prostheses rates. Revision rate due to hematoma: 0.2%
Garber and Bickell [42]	2015	600	NR	Retrospective	0.5%	All patients had CSD (removed POD#1)	Hematoma evacuation	Authors investigated delayed (>5 days) hematoma formation, not acute (<5 days) postop hematomas. Revision rate due to hematoma: 0%
Minervini et al. [44]	2006	504	Mean: 50 months	Retrospective	2&	NR	Conservative without drainage	Revision rate due to hematoma: 0%.
Sadeghi-Nejad et al. [43]	2005	425	Mean: 18 months	Retrospective	0.7%	All patients had CSD (removed POD #1 or 2)	NR	Revision rate due to hematoma: NR. Overall infection rate was 3.3%, not increased with use of drain.
Carson et al. [41]	2000	372	Mean 57 months	Retrospective	1.8%	NR	NR	Revision rate due to hematoma: NR
Goldstein, et al. [45]	1997	434	Mean 22.2 months	Retrospective	0.2%	NR	NR	Revision rate due to hematoma: NR
Wilson and Delk [46]	1996	917	NR	Case series (abstract)	1.8%	PD only: 2.9% PD and CSD: 3.6% PD, CSD and PIC: 0.9%	NR	Revision rate due to hematoma: NR

CSD closed suction drainage, IPP inflatable penile prosthesis, NR Not recorded, PIC Partial Inflation of Cylinders, POD post-operative day, SPP semi-rigid penile prosthesis

Table 48.1

Studies regarding reservoir-related non-infectious complications

Author	Year	Study population	Follow-up	Study design	Reservoir location	Complication rate	Reservoir-related type of complications	Comments
Clavell-Hernandez et al. [77]	2018	974	Mean: 20.4	Retrospective, Multicenter	612 Ectopic 362 SOR	Overall: 1.6% Ectopic: 2.0% SOR: 1.1%	Ectopic: Reservoir leak (n = 4) Palpation/pain (n = 3) Tubing torsion (n = 3) Intraperitoneal (n = 1) SOR: Bladder erosion (n = 1) Tubing torsion (n = 1) Reservoir Herniation (n = 2)	Recommend filling AMS Conceal to >80 mL, and if using Coloplast Cloverleaf: 75 cc reservoir or under-filled 125 cc reservoir to avoid muscle discomfort
Capoccia et al. [69]	2017	246	Median: 28.7 months	Retrospective chart review	230 SOR 16 ectopic	3.2%	SOR: Inguinal BH (n = 4) Spigelian BH (n = 1) Reservoir Herniation (n = 2) Autoinflation (n = 1)	2 patients with prior pelvic surgery developed incarcerated inguinal BHs. 1 autoinflation, 3 BHs, 2 reservoir hernias in the virgin pelvis cohort.
Gupta et al. [23]	2017	240	30 months	Retrospective	Ectopic SOR	1.6%	Reservoir leak (n = 2) Bladder perforation (n = 2)	Both bladder perforations occurred on SOR placement after RP
Karpman et al. [71]	2015	759	Mean: 17.8 months	Prospective Multicenter	572 SOR 177 Ectopic 10 Other^a	0.7%	Ectopic: Reservoir Herniation (n = 2) SOR: Herniation (n = 2) Autoinflation (n = 1)	Autoinflation secondary to capsular contraction.
Stember et al. [32]	2014	2687	48 months	Retrospective review	2239 SOR 447 Ectopic	2.3%	Ectopic: Palpable Reservoir (n = 2) Autoinflation (n = 2) Herniation (n = 6) SOR: Bladder injury: (n = 2) Herniation (n = 2)	No reported bladder injuries in the ectopic group vs n = 2 in the SOR group. No reported revisions for palpable reservoirs or autoinflation in SOR group.
Levine and Hoeh [17]	2012	>400	NR	Retrospective	SOR	NR	Bladder erosion (n = 1) Vascular injury (n = 2) Inguinal Hernia (n = 1) Reservoir herniation (n = 1)	Vascular injuries: EIV compression causing leg edema Bleeding from branch of EIV
Carson et al. [41]	2000	372	Mean 57 months	Retrospective	NR	2.4%	Autoinflation (n = 9)	Revision rate due to device malfunction was 17.5%
Furlow and Goldwasser [26]	1987	2023	NR	Retrospective	SOR	0.4%	Bladder Erosion (n = 6) Ileal conduit Erosion (n = 2)	All cases were salvaged successfully.