Management of Complications in Penile Prosthesis Surgery

Justin Parker, MDAssistant Professor of UrologyUniversity of South FloridaJames A. Haley VA Hospital

Disclosure

I am a consultant/speaker for Coloplast but have no conflicts regarding this presentation.

Objectives

Identify potential complications related to penile prosthesis surgery Understand treatment approaches for

management of prosthesis complications

Overview

Patients undergoing penile prosthesis placement overall have a high revision-free satisfaction rate– 69-98%1

Despite improvements in surgical technique and device design, complications are inevitable2-5

Perforation During Dilation

Can occur distal, proximal, lateral What do you do?

IMPLANT PERFORATION

•PROXIMAL•CAN CONTINUE WITH SURGERY•USE CONTRALATERAL CORPORA TO SIZE IMPLANT•DIFFERENT SURGICAL TECHNIQUES DESCRIBED TO CORRECT DEFECT:

•SUTURE SLING•DACRON SOCK•SUTURE SRPP TO TUNICA

2-0 PROLENE GOING THROUGH TUNICA-REAR TIP-TUNICA

IMPLANT PERFORATION

DISTAL• GENERAL RECOMMENDATION TO ABORT PENILE

IMPLANTATION• REMOVE CONTRALATERAL CYLINDER (if already placed)• PLACEMENT OF FOLEY CATHETER (3-5 DAYS)• ORAL ANTIMICROBIAL THERAPY

• SPECIAL CASES IMPLANT CAN BE PERFORMED• SEVERE FIBROSIS IN WHICH THE CORPORAL BODIES ARE

SEPARATE CHAMBERS• CREATION OF A HYPOSPADIAS AND PRIMARY REPAIR WITH

IMPLANT PLACEMENT HAS BEEN PERFORMED IN SELECT CENTERS

Corporotomy Plug Technique

Postero-lateral perforation during dissection of fibrotic corpora

“Plug” perforation with a small Hegar dilator and dissect a new corporal tunnel

Corporotomy Plug Technique

Floppy glans syndrome

Due to hypermobility of the glans penis despite shaft erection– Makes penetration difficult– Patients may complain of painful and unsatisfactory

intercourse Incidence difficult to determine due to uncommon

nature of FGS In addition to treatment, goal is to minimize

occurrence by utilizing proper technique at placement

Floppy Glans Syndrome- Manifestations

Ventral– SST or Concorde deformity

• Due to undersized or poorly positioned cylinders– True hypermobility

• Result from poor structural support of the glans by the tips of the corpora cavernosa

• Occurs in patients with appropriately sized cylinders

Floppy Glans Syndrome-Manifestations Dorsal

– Reverse SST• May be caused by a relative tightness of the dorsal penile

tissue compared to ventral• Notable dorsal glans angle when both inflated and deflated

– May be due to oversized cylinders– Owl Eye Deformity- appearance of impending erosion

Lateral– Secondary to intraoperative crossover

Flail penis- glans and distal shaft hypermobile– Due to significant undersizing

Dorsal deflection- Reverse SST

Owl Eye Deformity

Flail penis due to inadequate dilation

Floppy Glans Syndrome- Medical Management Improve erectile firmness

– PDE5’s– Intra-urethral Muse– Compounded intraurethral gel

• Preliminary results in post IPP patients with subjective benefit to symptoms and quality of life

• Penile pain is a limiting side effect– VED

Glans Fixation or Glanulopexy

Plication sutures placed on the dorsal aspect of the glanular Bucks fascia and secured proximally to the tunica albuginea.

Permanency of the glans position enhanced by deep scarring from dissecting the glans from cylinder dips

Mulhall et al.6– 90% patient satisfaction

Penoplasty

Glans realigned with the distal shaft with clamps on the hypermobile skin and dartos Excess skin and dartos excised in elliptical

fashion with large defect Closed in multiple layers to maintain the

realignment of the glans over the distal tips May be particularly effective in reverse SST

Dorsal Penoplasty

Distal Corporoplasty

Definitive surgical management of FGS as a result of improper sizing or placement is removal with resizing and reimplantation +/-corporoplasty Consider if evidence of Owl Eye deformity

and pending erosion with FGS May add penoplasty for definitive correction

if necessary

Distal Crossover- Lateral droop

Patient 1- Undersized implant

Patient 1- Correctly sized implant

Patient 2- Incorrect sizing and high riding pump

Patient 2

Patient 2

Patient 2

Cylinder Aneurysm

Cylinder Aneurysm

AMS (fabric cylinder with parylene coating)– May also occur with Coloplast Bioflex but more

unusual May occur secondary to corporotomy breakdown Requires removal and replacement of implant Tunica wall is now a weak point and has

increased chance of recurrence May require placement of SRPP or a hybrid

prosthesis if recurs

Impending Distal Erosion

May be due to infection, perforation at time to of dilation, “microperforations” with small dilators, oversizing, continuous pressure (especially SCI patients)

Try to prevent

Modification in Technique

Patient with impending distal lateral cylinder erosion

Implant tip removed and incision made through medial floor of

tunica

Dilation of new corporal space

Implant re-inserted and inflated, Tuttoplast is placed over the

distal edge of tunica and sewn to the lateral edges

Tuttoplast Windsock

Tuttoplast Windsock

Transglanular repair of impending erosion Shindel et al. J Sex Med.

2010

Fixation of the tip of the implant to the fibrotic capsule opposite to the side of impending erosion with synthetic, non-absorbable suture

Implant Erosion

Prosthetic clearly exposed, need to evaluate closely for infection

SRPP– Removal of ipsilateral cylinder– Foley and antibiotics

IPP– Removal of all components or ipsilateral cylinder– Possible SRPP on contralateral side- need to carefully

evaluate integrity of cylinder space– Foley and antibiotics

Pump Erosion

Pump Erosion

Prosthesis Infection

Most bacteria colonize prosthesis at time of implantation

Biofilm layer protects the bacteria from antibiotic activity and host defenses

Bacteria colonize the device and remain in a low-energy state for years before infection manifests itself

Infections- Management

Systemic antibiotics alone Explantation of entire prosthesis Removal of only a portion of prosthesis Explantation with reinsertion delayed for 72 hours

after continuous antibiotic irrigation Explantation with reinsertion delayed for 3 to 6

months Salvage protocol: explantation, vigorous irrigation

of wound, and reinsertion of device during same procedure

Mulcahy Salvage Protocol7

1. 80 mg/L Kanamycin and 50K units/L bacitracin in NS

2. ½ strength hydrogen peroxide3. ½ strength povidone-iodine solution4. Pressure irrigation with 5L NS with 1gm

vancomycin and 80mg gentamicin5. ½ strength povidone-iodine solution6. ½ strength hydrogen peroxide7. 80 mg/L Kanamycin and 50K units/L bacitracin

in NS

CHARACTERISTICS OF IPP INFECTIONS

Onset may occur at any time.– Acute: within days.– Latent: after months or even years.

Routes of infection:– Contamination during surgery.– Systemic (from bloodstream).– Local extention

Site of infection may occur on any part of device.

Contributing Factors

Length of procedure. Pre-operative patient preparation. Level of physician’s experience with

procedure. Hospital protocols (infection control). Traffic in operating room Patient’s health status

FREQUENCY OF IPP INFECTIONS

Reported infection rate for virgin implants is 3-5% (classic rate, now estimated at approximately 1% with “newer implants”)

Reported infection rate for revision surgeries is 5-15%. Although rare, infections can be severe.

– Average MD may only see one in five years.– IPP Infections are traumatic to both MD and patient.

NOTE: Because this is a surgery, infection rates will likely never reach 0%.

Abouassaly R., et. Al. Curr Urol Rep. 2004 Dec;5(6):460-6.

Infection prevention

Preoperative antibiotics choice Shave day of surgery Preoperative scrub- chloraprep superior to

betadine– USF prep

• Prescrub with 4% chlorhexidine scrub brushes• 2 chloraprep sticks• 3rd chloraprep after draping (caution with cautery)• Change gloves after foley placement and final prep

Postoperative antibiotics?

Eid- No Touch Technique

1511 implants performed from 2006-2010 with “No Touch Technique”– Infection rate of 0.46%

2% infection rate with standard technique

Eid JF. No-touch Technique. J Sex Med. 2011 8(1) 5-8.

Eid JF. No-touch Technique. J Sex Med. 2011 8(1) 5-8.

Eid JF. No-touch Technique. J Sex Med. 2011 8(1) 5-8.

Eid JF. No-touch Technique. J Sex Med. 2011 8(1) 5-8.

No touch variation

Severe Prosthesis Infection- not a candidate for salvage

Stimulan

Stimulan

Stimulan

Reservoir Issues

Placement during virgin cases– Space of Retzius– Ectopic placement– Improper position

Removal during revision surgery– Perils of injury to bladder, bowel, vessels– Cadaver studies noted inguinal ring 5-8 cm

from distended bladder, 2-4 cm from full bladder, and 2.5-4cm from external iliac vein8

– Drain and retain?

Midplaced Reservoir

Selective CT image of the perineal placed reservoir as demonstrated by the red arrow

Reservoir PlacementCaution when Removing!

Reservoir Erosion Into Bladder

Salvage after infection- Thoughts?

Worst Case Scenario

Summary

Penile prosthesis surgery has a high rate of satisfaction but complications can be devastating Surgical options exist to correct the various

complications of prosthetic surgery Ideally, proper technique should be utilized

to minimize postoperative issues If complications occur, action should be

take promptly to prevent need to device removal

References

1. Bernal RM, Henry GD. Contemporary patient satisfaction rates for three-piece inflatable penile prostheses. Adv Urol[Internet]. 2012;2012:707321.

2. Montague DK. Prosthetic Surgery for Erectile Dysfunction [Internet]. Tenth Edit. Campbell-Walsh Urology. Elsevier Inc.; 2012. 780-791.e2

3. Burnett AL. Evaluation and Management of Erectile Dysfunction [Internet]. Tenth Edit. Campbell-Walsh Urology. Elsevier Inc.; 2012. 721-748.e7

4. Lazarou S. Surgical treatment of erectile dysfunction. Erectile Dysfunction: Disease-Associated Mechanisms and Novel Insights into Therapy [Internet]. 2012. p. 162–84

5. Henry GD, Donatucci CF, Conners W, Greenfield JM, Carson CC, Wilson SK, et al. An outcomes analysis of over 200 revision surgeries for penile prosthesis implantation: a multicenter study. J Sex Med [Internet]. 2012;9(1):309–15.

6. Mulhall JP, Kim FJ. Reconstructing penile supersonic transporter (SST) deformity using glanulopexy (glans fixation). Urology. 2001;57(6):1160–2.

7. Mulcahy JJ, Brant, MD, Ludlow JK. Management of infected penile implants. Tech Urol. 1995. 1: 115-9. 8. Henry G et al. A guide for inflatable penile prosthesis reservoir placement: pertinent anatomical measurements of

the retropubic space. J Sex Med. 2014. 11(1) 273-8.