Penile Implants for the Surgical Correction of ED ... Implants for the Surgical Correction of ED ......
Transcript of Penile Implants for the Surgical Correction of ED ... Implants for the Surgical Correction of ED ......
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Penile Implants for the Surgical Correction of ED
Complicated by Peyronie’s Disease
Aaron C. Lentz, MD, FACS Associate Professor of Surgery
Duke University Division of Urologic Surgery
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Definition
“A wound-healing disorder occurring in genetically susceptible men whose tunica albuginea responds
inappropriately to trauma leading to a fibrotic, inelastic scar and penile deformity”
Ralph D et al. J Sex Med. 2010 Jul;7(7):2359-74 Hatzimouratidis K et al. Eur Urol. 2012;62(3):543-552
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History
Described in 1743 induratio penis plastica
Physically and psychological devastating
Poor understanding of pathophysiology
Remains a therapeutic dilemma
Schwarzer et al. BJU Int 2001; 88: 727 Rhoden et al. Int J Impot Res; 2001: 13 Mulhall et al. J Urol 2004; 171: 2350
Francois de la Peyronie
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Risk Factors
Genetic1-3 Trauma1,4,5 Vascular1,6 Other1,6,7
• Dupuytren’s contracture
• HLA-DQ5 • Paget’s disease • Family history
of PD
• Intercourse • Vacuum erection
devices (VED) • Penile invasive
procedures • Urethritis • Prostatectomy • Injection therapy
(vasoactive drugs) for ED
• Catheterization
• Diabetes • Hyperlipidemia • Hypertension • Heart disease • Smoking
• Alcohol • Low testosterone • Older age
1. Bjekic MD et al. BJU Int. 2006;97(3):570-574. 2. Nachtsheim DA et al. J Urol. 1996;156(4):1330-1334. 3. Jalkut M et al. Rev Urol. 2003;5(3):142-148. 4. Carrieri MP et al. J Clin Epidemiol. 1998;51(6):511-515. 5. Kadioglu A et al. Epidemiology of Peyronie’s disease. In: Levine LA, ed. Peyronie’s Disease: A Guide to Clinical Management. Totowa, NJ: Humana Press Inc; 2007. 6. La Pera G et al. Eur Urol. 2001;40(5):525-530. 7. Moreno SA et al. J Sex Med. 2009;6(6):1729-1735.
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AUA Guidelines 2015
Clinicians should assess patients as candidates for surgical reconstruction based on the presence of stable disease. (Clinical Principle)
Clinical Principle: A statement about a component of clinical care that is widely agreed upon by urologists or other clinicians for which there may or may not be evidence in the medical literature
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Natural History Acute (active)
Progression in plaque size and curvature deformity
Painful plaque and erections
Chronic (stable) Stable plaque size Stable curvature deformity Decrease of absence of pain
The psychosocial impact of PD (distress, self-image, sexual relationships, etc.) can span both phases
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History Taking Detailed history of symptoms including onset, duration,
severity, and exacerbating factors Pain Curvature deformity Changes in length/girth Distal flaccidity
Inciting event Trauma (“cracking” sensation or ecchymosis???)
Prior treatments employed Evaluations by other HCPs Sexual history/erectile function (e.g., IIEF)
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Assessment of Curvature
Ohebashalom M et al. J Sex Med. 2007 Jan;4(1):199-203
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AUA Guidelines 2015 Clinicians may offer penile prosthesis surgery to
patients with Peyronie's disease with erectile dysfunction (ED) and/or penile deformity sufficient to prevent coitus despite pharmacotherapy and/or vacuum device therapy. (Moderate Recommendation; Evidence Strength Grade C)
Moderate Recommendation (Grade C): Benefits > Risks/Burdens (or vice versa), Net benefit (or net harm) appears moderate, Applies to most patients in most circumstances but better evidence is likely to change confidence
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Peyronie’s Disease
Chronic Phase
Stable disease (12 mo. without pain) Compromised or inability to engage in
intercourse
No erectile dysfunction ED responsive to medical therapy
Reconstructive Surgery
Curvature < 60° No destabilizing deformity
Predicted length < 20%
Tunical Shortening Surgery Nesbit Procedure
Modified Nesbit Procedures
Curvature > 60° Destabilizing deformity Severe Penile Shortening
Tunical Lengthening (Incision and grafting)
Graft materials Autologous Grafts
Allografts Xenografts
Synthetic Grafts
ED nonresponsive to medical therapy
Inflatable penile prosthesis (IPP)
Severe Penile curvature Severe deformity
Severe penile shortening >2 cm tunical defect after plaque incision
IPP alone IPP with modeling IPP and grafting IPP and plication
Acute Phase (Chronic Phase not meeting
the criteria for surgery)
Medically and minimally invasive therapies
Kadioglu A. Nat Rev Urol. 2011;8:95-106
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Indications for Surgical Reconstruction
Stable disease (> 6 months) Painless deformity Compromised/unable to engage in coitus
(2o/2 deformity and/or inadequate rigidity) Failed conservative therapy Extensive plaque calcification Desire most rapid and reliable result
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PD—Surgical Algorithm
When rigidity adequate +/- pharmacotherapy 1) Tunica plication techniques
Simple curve < 60 degrees No hourglass or hinge-effect When length ↓ <20% total erect length
2) Incision/Partial Excision and Grafting Complex curve > 60 degrees Destabilizing hourglass or hinge
Levine LA et al. J Urol. 1997;158:2149-2152.
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Drawbacks for Tunica Plication for PD
Does not correct shortening May ↑ length loss Does not address hinge or hourglass Pain, knots, sensory changes possible ALL SHORTEN THE LONG SIDE OF
THE PENIS! For every 15°of correction you lose ~ 1cm!
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Drawbacks for Incision and Grafting Procedures
May worsen pre-operative ED 5-53% ED rate!
Curvature may recur Penile/glans numbness a risk Plication sutures may still be necessary Prolonged recovery in some cases Rare, reported cases of avascular necrosis
and wound healing problems
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Drawbacks for IPP’s
Infection (1-2% with coated implants) Penile shortening (not all from implant!) Mechanical failure Difficulty with device operation Diminished sensitivity (rare) Persistent curvature However……..
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Satisfaction Author # Pts/Time Patient Partner
Bettochi 79 (2004-08) 97% --
Natali 33 (1990-2004) 97% 91%
Brinkman 248 (1992-98) 69% --
Carson 207 (1987-1996) 76% --
Montorsi 200 (1986-1997) 98% 96%
Holloway 145 (1990-1994) 85% 76%
Goldstein 234 (1989-1993) 89% --
Garber 50 (pre-1994) 98% 96%
Goldstein 96 (1989-19910 77% --
Levine (2-piece) 146 (1999-2004) 85% 76%
Bernal et al. Adv Urol. 2012; 707321
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Pre-operative Consent Set expectations regarding outcome
Persistent/Recurrent Curvature Goal “Functionally Straight” <20° Insure stable disease pre-op
Change in length (VERY IMPORTANT) ↓ length from PD + ↓ length from IPP =
Diminished rigidity Use implants with maximum rigidity! Decreased Sexual Sensation
Rare and doesn’t usually compromise orgasm/ejaculation
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Artificial Erection
Determine direction and severity of the deformity My Protocol:
10 cc’s of 2% lidocaine with 50 cc’s of NS Manual compression
This provides: Information regarding the degree of deformity Dilation of the corporal bodies Post-operative analgesia
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IPP Only for PD Results Mulhall et al. 2004
20/22 pts corrected to <10°when <45° Chaudhary et al. 2005
18/46 pts corrected to <10° Chung et al. 2012
127/138 pts corrected to <10° Does not matter if penoscrotal or infrapubic
Mulhall et al. J Sex Med 2004;1:318-32 Chaudhary et al. Urology 65(4),2005 Chung et al. J Sex Med 2013;10:2855-2860
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AUA Guidelines 2015 Clinicians may perform adjunctive intra-
operative procedures, such as modeling, plication or incision/grafting, when significant penile deformity persists after insertion of the penile prosthesis. (Moderate Recommendation; Evidence Strength Grade C)
Clinicians should use inflatable penile prosthesis for patients undergoing penile prosthetic surgery for the treatment of Peyronie's disease. (Expert Opinion)
Expert Opinion: A statement, achieved by consensus of the Panel, that is based on members' clinical training, experience, knowledge, and judgment for which there is no evidence
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PD—Prosthesis/Manual Modeling
Described by Steve Wilson in 1994 Requires high-pressure cylinder
Coloplast Titan or AMS CX (Never LGX!)
Place prosthesis first—close corportomies Protect pump—shod tubing Bend and hold x 60-90 sec
If <30 degrees, no additional measures needed
Repeat PRN
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IPP Modeling
Rate of urethral disruption is ~4-5%
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Manual Modeling Tips
Make certain the cylinder + RTE are same Leave some fluid in the cylinders (30-40%)
for the first 30 days ~4-5% risk of urethral injury
If injury occurs, only remove that cylinder
Warn patients that some curvature will persist when the penis is flaccid, but the erection will be straight.
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IPP Outcomes Data w/IPP + Modeling
Study (year)
Procedure No. pts f/u (mos.)
Straight (%)
Shortening (%)
Infection (%)
Need for
revision
Satisfaction (%)
Montague, 1996 IPP 34 NR 100 NR 6 NR NR
Levine, 2000 IPP 46 39 100 7 2 0 NR
Wilson, 2001 IPP 104 >60 NR NR 4.8 4.8 99
Levine, 2010 IPP 90 49 4 3 1 20 84
Chung, 2012 IPP 138 >35 92 62 2 6 79
Yafi et al. Curr Urol Rep (2015) 16:21
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IPP + Plication First described 2004 Best for curvature between 30-60 degrees Advantages
Less operative time ↓ risk of numbness, urethral injury, wound
breakdown (no circumcision required) Immediate correction of curvature Quicker recovery compared to grafting
Rahman NU et al. J Urol 2004;171:2346-9 Chung PH et al. J Sex Med 2014;11:1593-1598
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IPP + Plication Surgical Technique
Chung PH et al. J Sex Med 2014;11:1593-1598
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IPP + Plication Results
Chung PH et al. J Sex Med 2014;11:1593-1598
A = Change in Penile Curvature? B = Change in penile length? C = Adequate for penetration? D = Improvement?
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IPP + Relaxing Incision Techniques
Relaxing Incision Transcorporal Plaque Incision “Scratch” Technique
Advantages No loss of length No need for graft material or plication suture
Risks Penile numbness if NVB mobilized Cylinder herniation
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IPP + Relaxing Incisions Surgical Technique: Incision without Grafting
Montorsi F et al. J Urol 1993;150:1819-21 Djordjevic and Kojovic. Asian Journal of Andrology 2013;15:391-394
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IPP + Relaxing Incisions Surgical Technique: Transcorporal Incision
Sheer O. J Sex Med 2011;8:589-93
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Perito Scratch Technique
Perito P and Wilson SK. J Sex Med 2013;10:1194–1197 Martinez D et al. J Sex Med2015:12(suppl 2):101-183
Can also use Metzenbaum scissors or a Heaney curette
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IPP + Grafting Rarely necessary Main Indications
Severe curvature > 60 degrees Large dorsal plaques Ventral curvature Presence of residual curve after modeling and
tunical incision All relaxing incisions > 2 cm
Must warn patients about glans numbness!
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IPP + Grafting Surgical Technique
Place the implant Mobilize the NVB or corpus spongiosum Mark and incise the plaque (Bovie < 35 W) Graft Material (dealer’s choice)
Biologics: Tachosil, SIS, Tutoplast, Acell, etc. Synthetic: GoreTex (1 mm) Autologous: Saphenous vein, fascia lata, etc.
Suture: 4-0 PDS or GoreTex Drain with a TLS drain
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IPP + Grafting Surgical Technique
Courtesy of L. Levine
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IPP + Grafting Surgical Technique
Courtesy of L. Levine
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IPP + Grafting Surgical Technique
Courtesy of L. Levine
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IPP + Grafting Surgical Technique
Courtesy of L. Levine
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IPP + Grafting Surgical Technique
Courtesy of L. Levine
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First described in 2012 Based on 3 key elements
Sliding maneuver for restoration of length Ventral or dorsal incisions for ↑ girth With or without graft (SIS)
New Technique (2015) Buck’s fascia used to close tunical defects rather
than SIS Graft
Dorsal-Ventral Patch “The Sliding Technique”
Rolle et al. J Sex Med 2012;9:2389-2395 Egydio PH et al. BJUI 2015: PMID: 25644141 Egydio PH et al. J Sex Med 2015;12:1100-1104
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Dorsal-Ventral Patch
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Dorsal-Ventral Patch
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143 consecutive patients (77 with PD and ED) Mean age 56 (40-72) Operative Time
Malleable Implant (n=133), 93 (64‒122) min Inflatable (n=10), 121 (100‒164) min
Mean length improvement 3.1 cm (2-7 cm) No infections, 3 hematomas IIEF ↑ from 24 at baseline to 60 at 6 mo.
Dorsal-Ventral Patch Results
Egydio PH et al. BJUI 2015: PMID: 25644141
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Take Home Points PD is not a rare disorder -- >10% of men over 50! PD frequently associated with ED -- 50-90% There is no non-surgical “cure” for PD
Surgical treatments are imperfect
Psychological issues in every patient Diagnosis is easy, treatment remains a challenge Informed consent is critical Don’t over promise!
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Questions?
Thank goodness for IPPs!!!