The Two-Piece Prosthesis Has No Role in the Modern Era. Point/Counterpoint: CON

Transcription

1 The Two-Piece Prosthesis Has No Role in the Modern Era Point/Counterpoint: CON SEXUAL MEDICINE SOCIETY OF NORTH AMERICA MAY 16, 2015 ASHLEY H. TAPSCOTT, DO CAROLINA UROLOGY PARTNERS HUNTERSVILLE, NC

2 Disclosures Consultant/Speaker American Medical Systems Coloplast Corporation

3 Inflatable Penile Prostheses Over 40 years Penile implants held major position in treatment algorithm for patients with ED Historically data reflects mostly selfadministered vs validated questionnaires Studies now producing objective data No overt papers 2 piece vs 3 piece for same patient

4 AmericanMedical Systems, Minnetonka, MN, USA Coloplast Corporation, Minneapolis, MN, USA Product Comparison

5 Product Comparison

6 Ambicor Introduced 1994, successor to Dynaflex (1 piece) 1998 redesign RTEs: increased durability Tubing insertion: stress protection at flex point

7 Two-Piece Prosthesis 2007, Levine & Morgentaler First objective and subjective report of performance of revised IPP, 146 patients Up to 6 years follow up High device viability Low reoperation and infection rates No reported complications High patient and partner satisfaction No 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.

8 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.

9 Surgical Approach Surgeon preferences play a role in device choice Penoscrotal 2-piece 3-Piece Infrapubic 3-Piece

10 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: Carson CC. Efficacy of antibiotic impregnation of inflatable penile prostheses in decreasing infection in original implants. J Urol. 2004;171: 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.

11 Infection 2-Piece, Wet within packaging, prefilled o o Precludes InhibiZone 2007 study: 0.7% infection rate

12 Inflation and Deflation Pump/Inflation No available data on number of squeezes for either device Patient dexterity

13 Inflation and Deflation 2-Piece: Easy deflation, inflation Fewest pumps inherent in design

14 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: 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: 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: 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:

15 Flaccidity/Concealment 2-piece Theoretical concern for inadequate concealment Ease of concealment when deflated 92% patients Some 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.

16 Rigidity/Erection Quality Several factors are responsible for cylinder rigidity FIXED Cylinder length Cylinder girth Cylinder pressure NOT FIXED, dependent on patient Wall thickness - +/- presence of capsule Scarring, +/- PD Tissue elasticity

17 Mechanical Reliability 2-piece 146 implants Mean 38 month follow up: 0.7% failure 3 piece, Longest-term study, 2,000 implants 10 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 6 Wilson 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):

18 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

19 Reservoir Placement Inguinal ring, gateway to reservoir placement Henry et al, Cadaver Study, external inguinal ring cm from the external iliac vein cm from the decompressed bladder 2 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(suppl 4):192, A27.

20 Reservoir Removal Reported life-threatening bleeding with removal Drain and retain in uninfected cases Same vs different surgeon implanting/explanting Levine LA, Hoeh MP. Review of penile prosthetic reservoir: Complications and presentation of a modified reservoir placement technique. J Sex Med 2012;9: 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:

21 Ectopic Reservoir Placement Alternative sites Anterior/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:

22 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

23 Ectopic Reservoir Placement In some patients... Safest??.. No reservoir

24 Ectopic Reservoir Placement

25 Ectopic Reservoir Placement NOT A MAGICAL UNICORN

26 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 for inflatable penile prosthesis among members of the Sexual Medicine Society of North America. J Sex Med 2013;10:

27 Rogue Reservoir Patients Patient Anatomy Hostile pelvis o Multiple/Combined/Repeated ABD procedures o Bladder reconstruction o Bilateral hernia repair +/- mesh Organ transplant (kidney) Thin habitus Surgery on anticoagulation Reconstruction/plastics: Neophallus

28 Best Patient Outcome Surgeon Comfort + Patient Comfort Need the right implant for the right patient = options

29 Patient vs Patient

30 Patient vs Patient

31 Patient vs Patient

32 ?

33 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

34 Two-Piece Prosthesis Safe Effective Mechanically reliable Low revision rate Low infection rate Good patient and partner satisfaction Cost

35 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

36

37 LONG LIVE THE 2-PIECE