SEXUAL MEDICINE SOCIETY OF NORTH AMERICA

MAY 16, 2015

A S H L E Y H . T A P S C O T T , D OC A R O L I N A U R O L O G Y P A R T N E R S

H U N T E R S V I L L E , N C

The Two-Piece Prosthesis Has No Role in the Modern Era

Point/Counterpoint: CON

Disclosures

Consultant/Speaker American Medical Systems Coloplast Corporation

Inflatable Penile Prostheses

Over 40 years Penile implants held major position in treatment

algorithm for patients with ED

Historically data reflects mostly self-administered vs validated questionnaires

Studies now producing objective data

No overt papers 2 piece vs 3 piece for same patient

Product Comparison

AmericanMedical Systems, Minnetonka, MN, USAColoplast Corporation, Minneapolis, MN, USA

Product Comparison

Ambicor

Introduced 1994, successor toDynaflex (1 piece)

1998 redesign RTEs: increased durability Tubing insertion: stress

protection at flex point

Two-Piece Prosthesis

2007, Levine & Morgentaler First objective and subjective report of performance

of revised IPP, 146 patientsUp to 6 years follow up

High device viability Low reoperation and infection ratesNo reported complications

High patient and partner satisfactionNo removals due to dissatisfaction

Lux M, Reyes-Vallejo L, Morgentaler A, Levine LA. Outcomes and satisfaction rates for the redesigned 2-piece penile prosthesis. J Urol.2007;177(1):262–6.

Two-Piece Prosthesis

91% Ease of use 95% Little to no trouble learning to use device 95% Rigidity suitable for intercourse

Free from reoperation 1 year : 99.2% 3 years: 99.2% ≥ 4 years : 91%

Lux M, Reyes-Vallejo L, Morgentaler A, Levine LA. Outcomes and satisfaction rates for the redesigned 2-piece penile prosthesis. J Urol.2007;177(1):262–6.

Surgical Approach

Surgeon preferences play a role in device choice

Penoscrotal 2-piece 3-Piece

Infrapubic 3-Piece

Infection

Decreasing infection rates: active area of design, protocol development Mechanical aspect of device (coating)Reduced infections and colonization Decreased incidence from 3-5%, to 1-2%

Surgeon technique/experience Patient selection Other factors/quality measures

Wilson SK, Salem EA, CostertonW. Anti-infection dip suggestions for the Coloplast Titan inflatable penile prosthesis in the era of the infection retardant coated implant. J Sex Med. 2011;8:2647–54. Carson CC. Efficacy of antibiotic impregnation of inflatable penile prostheses in decreasing infection in original implants. J Urol. 2004;171:1611–4. Richardson B, Caire A, Hellstrom W. Retrospective long-term analysis of Titan hydrophilic coating: positive reduction of infection compared to non-coated device. J Sex Med. 2010;7:28.

Infection

2-Piece, Wet within packaging, prefilled

o Precludes InhibiZone® o 2007 study: 0.7% infection rate

Inflation and Deflation

Pump/InflationNo available data on “number of squeezes”

for either devicePatient dexterity

Inflation and Deflation

2-Piece: Easy deflation, inflation Fewest pumps inherent in design

Penile Length

Complaint not unique to 2 piece design Overall 72% patients subjective decrease in penile

length Despite lack of significant difference in pre and post

operative measurements

Maximize cylinder length/perceived length “Sellers Sizing”, preoperative VED Henry, NLMT, aggressive corporal measurement Wilson, Severe fibrosis: narrow expander upsizing Carrion, ventral phalloplasty

Deveci S,Martin D, ParkerM,Mulhall JP. Penile length alterations following penile prosthesis surgery. Eur Urol. 2007;51:1128–31.Sellers T, Dineen M, Salem EA, Wilson SK. Vacuum preparation, optimization of cylinder length and postoperative daily inflation reduces complaints of shortened penile length following implantation of inflatable penile prosthesis. Adv Sex Med. 2013;03:14–8. Henry G, Houghton L, Culkin D, Otheguy J, Shabsigh R, Ohl DA. Comparison of a new length measurement technique for inflatable penile prosthesis implantation to standard techniques: outcomes and patient satisfaction. J Sex Med. 2011;8:2640–6. Wilson SK, Delk JR, Mulcahy JJ, Cleves M, Salem EA. Upsizing of inflatable penile implant cylinders in patients with corporal fibrosis. J Sex Med. 2006;3:736–42. Miranda-Sousa A, Keating M, Moreira S, Baker M, Carrion R. Concomitant ventral phalloplasty during penile implant surgery: a novel procedure that optimizes patient satisfaction and their perception of phallic length after penile implant surgery. J Sex Med.2007;4:1494–9.

Flaccidity/Concealment

2-piece

Theoretical concern for inadequate concealmentEase of concealment when deflated92% patientsSome men enjoy appearance of partial penile fullness

Lux M, Reyes-Vallejo L, Morgentaler A, Levine LA. Outcomes and satisfaction rates for the redesigned 2-piece penile prosthesis. J Urol. 2007;177(1):262–6.

Rigidity/Erection Quality

Several factors are responsible for cylinder rigidityFIXEDCylinder lengthCylinder girthCylinder pressure

NOT FIXED, dependent on patientWall thickness - +/- presence of capsuleScarring, +/- PDTissue elasticity

2-piece 146 implants Mean 38 month follow up: 0.7% failure

3 piece, Longest-term study, 2,000 implants10 years: failure 21%15 years: failure 29%

Lux M, Reyes-Vallejo L, Morgentaler A, Levine LA. Outcomes and satisfaction rates for the redesigned 2-piece penile prosthesis. J Urol.2007;177(1):262–6Wilson SK, Delk JR, Salem EA, ClevesMA. Long-term survival of inflatable penile prostheses: single surgical group experience with 2,384 first-time implants spanning two decades. J Sex Med. 2007;4(4 Pt 1):1074–9.

Mechanical Reliability

Reservoir Placement

2-piece “Hostile” abdomen Independent of future abdominal surgeries Surgeon preference to avoid reservoir placement

3-piece Reports of placement into surrounding structures +/-

experience Advances in surgical techniques and device modifications

Reservoir Placement

Inguinal ring, gateway to reservoir placementHenry et al, Cadaver Study, external inguinal ring2.5–4 cm from the external iliac vein5.3–8 cm from the decompressed bladder2–4 cm from the filled bladder

Altered in location, distance in any abdominal/pelvic surgery without consideration for mesh, new organ, scarring, adhesions

Henry G, Jones L, Carrion R, Bella A, Karpman E, Christine B, Kramer A. Pertinent anatomical measurements of the retropubic space: A guide for inflatable penile prosthesis reservoirs shows that the external iliac vein is much closer than thought. J Sex Med 2012;9(suppl4):192, A27.

Reservoir Removal

Reported life-threatening bleeding with removal “Drain and retain” in uninfected casesSame vs different surgeon implanting/explanting

Levine LA, Hoeh MP. Review of penile prosthetic reservoir: Complications and presentation of a modified reservoir placementtechnique. J Sex Med 2012;9:2759–69.Hinds PR, Wilson SK, Sedeghi-Nejad H. Dilemmas of inflatable penile prosthesis revision surgery: What practices achieve the best outcome and lowest infection rates. J Sex Med 2012;9:2484–92.

“Ectopic” Reservoir Placement

Alternative sitesAnterior/Posterior to

abdominal wall musculature

Potentially safer location? Worth risk of palpable or

herniated reservoir/affect patient satisfaction

? Create new complications

Stember DS, Garber BB, and Perito PE. Outcomes of abdominal wall reservoir placement in inflatable penile prosthesis implantation: A safe and efficacious alternative to the space of Retzius. J Sex Med 2014;11:605–612.

“Ectopic” Reservoir Placement

Survey of high volume prosthetic surgeons

90% SMSNA members believe placing the reservoir in an “ectopic” location can be advantageous for patient safety

“Ectopic” Reservoir Placement

In some patients.......Safest??.. No reservoir

“Ectopic” Reservoir Placement

“Ectopic” Reservoir Placement

NOT A MAGICAL UNICORN

“Ectopic” Reservoir Placement

Ectopic reservoir placement is not the panacea for all implant patients

DESPITE excellent described technique and safety advantages

Not all surgeons will be comfortable or proficient Not all patients will be candidates Not all patients will be accepting

Karpman E, Sadeghi-Nejad H, Henry GD, Khera M, Morey AF. Current opinions on alternative reservoir placement forinflatable penile prosthesis among members of the Sexual Medicine Society of North America. J Sex Med 2013;10: 2115–20.

Rogue Reservoir Patients

Patient Anatomy“Hostile” pelvis

o Multiple/Combined/Repeated ABD procedureso Bladder reconstructiono Bilateral hernia repair +/- mesh

Organ transplant (kidney) Thin habitusSurgery on anticoagulation Reconstruction/plastics: Neophallus

Best Patient OutcomeSurgeon Comfort + Patient Comfort

Need the right implant for the right patient = options

Patient vs Patient

Patient vs Patient

Patient vs Patient

?

Goal of IPP placement is to improve quality of life by resumption of sexual activity

Device/technique adjustment vs compromise for complications

Preoperative counseling, assessment of all patient qualities, proper device selection = higher patient satisfaction

Two-Piece Prosthesis

Safe Effective Mechanically reliable

Low revision rate Low infection rate Good patient and partner satisfaction Cost

There continues to be a valuable role for the 2 piece

Do not underestimate the role of SIMPLICITY

Placement, Performance, Use Especially in complicated patients

LONG LIVE THE 2-PIECE