Penile Implant Should be Offered Early Landon Trost, MD Assistant Professor in Urology Mayo Clinic, Rochester, MN SMSNA AUA May 16 th, 2015 2013 MFMER slide-1
Clear Indications for Penile Implants Men with PD and ED unresponsive to ICI Less Clear ED responding to ICI Borderline response to PDEs, especially higher risk Elevated age, DM, prior prostatectomy Significant deformities Hourglass w/ distal softening 2013 MFMER slide-2
Natural History of ED in PD Men Does ED progress more rapidly in PD men? 2013 MFMER slide-5
Levine, et al: 1 176 PD men ED in PD Men Retrospective questionnaire (EDITS) Study period 3 years Mulhall, et al: 2 246 PD men presenting in acute phase (< 6 mo) Mean age 52, follow-up 15 mo, PD 3 mo IIEF obtained Men with insufficient erections with ICI excluded Gelbard, et al: 3 97 PD men Retrospective questionnaires PD 3 mo to 8 years 1 Levine LA, et al: 2002 IJIR. 2 Mulhall JM, et al: 2006 J Urol. 3 Gelbard MK, et al: 1990 J Urol. 2013 MFMER slide-6
Pre and Post PD Onset 10 % of Pts Reporting Decreased Erectile Capacity Levine, et al: 1 59 If your penis had no 60 deformity, would the rigidity that you currently 50 Suggests that erectile function worsens with onset of 40 experience when sexually aroused be adequate for 40 PD Before vaginal penetration and be After 30 maintained through sexual intercourse? 20 0 1 - Levine LA, et al: 2002 IJIR. 2013 MFMER slide-7
90 80 70 83 79 ED During Acute Phase Baseline vs 15 mo Follow-up 90 80 70 72 84 67 Baseline Follow-up 60 50 40 30 20 10 No change in subjective complaints or EFD (only 19.2 18.4 12.2 11.4 % of Patients 60 50 men who were capable of penetration) 42 40 Decreased ability to penetrate 30 20 10 35 22 0 ED Penile Length (cm) EFD Score 0 Length Loss Difficult Penetration No Penetration Mulhall JP, et al: 2006 J Urol. 2013 MFMER slide-8
Intercourse Ability By Duration of PD % of Patients 50 45 40 35 30 25 20 15 10 11 2 yr 2-4 yr 4 yr 23 48 32 No difference in rates of ED based on duration of PD 37 45 5 0 Better Same Worse Gelbard MK, et al: 1990 J Urol. 2013 MFMER slide-9
Natural History of ED in PD Men Does ED in PD men respond similarly to PDE5s? 2013 MFMER slide-10
Responsiveness to PDE5s Levine, et al: 1 71% of PD men with ED satisfied or very satisfied with sildenafil 50mg % of Patients % Responding Yes to SEP3 90 83 Placebo 80 Tadalafil 5mg 68 70 65 62 58 58 60 60 55 48 50 43 40 40 33 34 34 30 30 30 20 10 19 48 0 DM 65 yr HTN CVD HLP BMI 30 Mild ED Mod ED Sev ED 1 - Levine LA, et al: 2002 IJIR. *Graph adapted from Porst H, et al: 2014 Eur Urol. 2013 MFMER slide-11
Summary Natural History of ED in PD PD may result in initial worsening of erectile function No evidence that progression of ED in PD men is more rapid Develop ED at same rate PD men appear to respond to traditional ED therapies at similar rates to non PD men 2013 MFMER slide-12
What is the Impact of PD Surgical Therapies on Sexual Function? 2013 MFMER slide-14
Impact of PD Surgery on ED 2013 MFMER slide-15
Plication Outcomes N= (f/u mo) Author (Year) Straight (%) ED (%) Sense (%) Length (%) Satisfied (%) Essed Schroeder / TAP 19 (40) Leonardo (2012) 75 48 (<24) Dugi (2010) 2 0 93 26 (12) Kim (2008) 65 11 19 69 65 15 (21) Kadioglu (2008) 87 95 61 (72) Taylor (2008) 87 19 31 18 82 76 (71) Paez (2007) 42 61 66 68 (29) Greenfield (2006) 99 7.3 4 99 28 (30) Van der Horst (2004) 100 28 74 78 44 (49) Chahal (2001) 29 36 32 90 21 (30) Schultheiss (2000) 57 3 46 16-dot Plication 132 (31) Gholami (2002) 85 6 6 41 96 Total Plication 74 19 27 43 90 Total Corporoplasty 89 2 8 24 82 2013 MFMER slide-16
I&G Outcomes Graft Material N= F/U % Straight % ED % Satisfaction I&G Combined Plication + Corporoplasty 1254 10.5 87 17 84 1321 83 9 86 *Levine LA, Larsen SM: 2013 Asian J Androl. 2013 MFMER slide-17
What is the Role for Prostheses in the Management of PD? 2013 MFMER slide-18
Current Surgical Algorithm Plication / Corporoplasty N Curve >60-70 Multi-planar Hourglass / Hinge Predicted Loss of Length >20% ED w/ PDE5s? Y 3-5 I&G Y Prosthesis Curvature > 20 Y Manual modeling 1,2 1,2 Curvature > 20 Y Plication, Incisions, Excisions, Grafting 1 Levine LA, et al: 2010 J Sex Med 2 Garaffa G, et al: 2011 BJU Int. 3 Mulhall J, et al: 2005 J Sex Med. 4 Hatzimouratidis K, et al: 2012 Eur Urol. 5 Ralph D, et al: 2010 J Sex Med. 2013 MFMER slide-19
Patient Examples 60 yo PD male 40 dorsal curvature; difficulty penetrating IIEF, EFD 9 Requiring ICI *** 2013 MFMER slide-20
Current Surgical Algorithm Plication / Corporoplasty N Curve >60-70 Multi-planar Hourglass / Hinge Predicted Loss of Length >20% ED w/ PDE5s? Y 3-5 I&G Y Prosthesis Curvature > 20 Y Manual modeling 1,2 1,2 Curvature > 20 Y Plication, Incisions, Excisions, Grafting 1 Levine LA, et al: 2010 J Sex Med 2 Garaffa G, et al: 2011 BJU Int. 3 Mulhall J, et al: 2005 J Sex Med. 4 Hatzimouratidis K, et al: 2012 Eur Urol. 5 Ralph D, et al: 2010 J Sex Med. 2013 MFMER slide-21
Patient Examples 60 yo PD male 40 dorsal curvature; difficulty penetrating IIEF, EFD 9 Requiring ICI Treated with Xiaflex; restored ability to penetrate *** 2013 MFMER slide-22
New Paradigm? Xiaflex Xiaflex N ED w/ PDE5s? Y Prosthesis Curve Cont d Curve >60-70 Multi-planar Hourglass / Hinge Predicted Loss of Length >20% 3-5 Curvature > 20 Y Manual modeling 1,2 Plication / Corporoplasty Y I&G 1,2 Curvature > 20 Y Plication, Incisions, Excisions, Grafting 1 Levine LA, et al: 2010 J Sex Med 2 Garaffa G, et al: 2011 BJU Int. 3 Mulhall J, et al: 2005 J Sex Med. 4 Hatzimouratidis K, et al: 2012 Eur Urol. 5 Ralph D, et al: 2010 J Sex Med. 2013 MFMER slide-23
Are There More Sensitive Predictors to Identify ED after PD Surgery? 2013 MFMER slide-24
Factors Impacting Surgical Outcome Increase Risk of ED: Age > 55-60 1 Pre-op sexual function 2 Venous leak 1,3 Decreased pre-op sexual activity Disease characteristics 1 Curvature >60 Operative variables 1,4 Ventral grafts Larger grafts (> 3cm) Egydio vs H-type incision Do NOT Increase Risk of ED: Disease characteristics 5 Duration of disease Plaque size / location Narrowing Patient characteristics 6 Comorbidities (HTN, DM) Pre-op PDE5 use 1 Flores S, et al: 2011 J Sex Med. 2 Levine LA, et al: 2007 J Sex Med. 3 - Alphs HH, et al: 2010 J Sex Med. 4 - Mulhall JP, et al: 2005 J Sex Med. 5 Levine LA, et al: 2005 J Sex Med. 6 Taylor FL, et al: 2012 J Sex Med. 2013 MFMER slide-25
What Percentage of Patients Will Have These Predictors? 2013 MFMER slide-26
Factors Impacting Surgical Outcome Increase Risk of ED: Age > 55-60 1 Pre-op sexual function 2 Venous leak 1,3 Decreased pre-op sexual activity Disease characteristics 1 Curvature >60 Operative variables 1,4 Ventral grafts Larger grafts (> 3cm) Egydio vs H-type incision Do NOT Increase Risk of ED: Disease characteristics 5 Duration of disease Plaque size / location Narrowing Patient characteristics 6 Comorbidities (HTN, DM) Pre-op PDE5 use 1 Flores S, et al: 2011 J Sex Med. 2 Levine LA, et al: 2007 J Sex Med. 3 - Alphs HH, et al: 2010 J Sex Med. 4 - Mulhall JP, et al: 2005 J Sex Med. 5 Levine LA, et al: 2005 J Sex Med. 6 Taylor FL, et al: 2012 J Sex Med. 2013 MFMER slide-27
Patient Age at Presentation Mean age = 45-59 years 1-4,6 Age of Presentation < 40 = 9.4-10.8% 1,5 21% 44% 24% 0% 0% 3% 7% 2% 10 20 30 40 50 60 70 80 Age 1 Kadioglu A, et al: 2002 J Urol.*Graph adapted. 2 Mulhall JP, et al: 2006 J Urol. 3 Rhoden EL, et al: 2010 JSM. 4 Grasso M, et al: 2007 Arch Esp Urol. 5 Deveci S, et al: 2007 JSM. 6 Chung E, eet al: 2012 BJUI. 2013 MFMER slide-28
Factors Impacting Surgical Outcome Increase Risk of ED: Age > 55-60 1 Pre-op sexual function 2 Venous leak 1,3 Decreased pre-op sexual activity Disease characteristics 1 Curvature >60 Operative variables 1,4 Ventral grafts Larger grafts (> 3cm) Egydio vs H-type incision Do NOT Increase Risk of ED: Disease characteristics 5 Duration of disease Plaque size / location Narrowing Patient characteristics 6 Comorbidities (HTN, DM) Pre-op PDE5 use 1 Flores S, et al: 2011 J Sex Med. 2 Levine LA, et al: 2007 J Sex Med. 3 - Alphs HH, et al: 2010 J Sex Med. 4 - Mulhall JP, et al: 2005 J Sex Med. 5 Levine LA, et al: 2005 J Sex Med. 6 Taylor FL, et al: 2012 J Sex Med. 2013 MFMER slide-29
VOD in PD Serefoglu et al: 1 Graph Chung et al: 2 56% VOD in men with ED and PD Usta et al: 3 PD (all comers) = 23% VOD ED alone = 43% VOD 70 60 50 40 30 20 10 0 19 31 VOD Mixed Vascular 15 11 51 54 16 44 Ventral Dorsal Lateral Total 1 Serefoglu EC, et al: 2015, IJIR. 2 Chung E, et al: 2011 JSM. 3 Usta MF, et al: 2004 J Urol. 2013 MFMER slide-30
Factors Impacting Surgical Outcome Increase Risk of ED: Age > 55-60 1 Pre-op sexual function 2 Venous leak 1,3 Decreased pre-op sexual activity Disease characteristics 1 Curvature >60 Operative variables 1,4 Ventral grafts Larger grafts (> 3cm) Egydio vs H-type incision Do NOT Increase Risk of ED: Disease characteristics 5 Duration of disease Plaque size / location Narrowing Patient characteristics 6 Comorbidities (HTN, DM) Pre-op PDE5 use 1 Flores S, et al: 2011 J Sex Med. 2 Levine LA, et al: 2007 J Sex Med. 3 - Alphs HH, et al: 2010 J Sex Med. 4 - Mulhall JP, et al: 2005 J Sex Med. 5 Levine LA, et al: 2005 J Sex Med. 6 Taylor FL, et al: 2012 J Sex Med. 2013 MFMER slide-32
Disease at Presentation Curvature 1-4 61 *Mean 41-45º 43 20 39 25 19 Maximum Minimum <30 30-60 >60 1 Kadioglu A, et al: 2002 J Urol. 2 Mulhall JP, et al: 2006 JSM. 3 Kadioglu A, et al: 2004 IJIR. 4 Grasso M, et al: 2007 Arch Esp Urol. 2013 MFMER slide-33
Surgical Algorithm Xiaflex Xiaflex N ED w/ PDE5s? Y Prosthesis Curve Cont d Plication / Corporoplasty Curve >60-70 Multi-planar Hourglass / Hinge Predicted Loss of Length >20% Y 3-5 I&G Curvature > 20 Y Manual modeling 1,2 1,2 Curvature > 20 Y Plication, Incisions, Excisions, Grafting 1 Levine LA, et al: 2010 J Sex Med 2 Garaffa G, et al: 2011 BJU Int. 3 Mulhall J, et al: 2005 J Sex Med. 4 Hatzimouratidis K, et al: 2012 Eur Urol. 5 Ralph D, et al: 2010 J Sex Med. 2013 MFMER slide-34
Summary of High Risk Indicators after PD Surgery Age 40-50% of PD men > age 55 Penile U/S 23-60% of PD men w/ VOD Curvature 19-25% with curvatures >60 Includes nearly all I&G candidates A high percentage of men with PD are at risk for ED after surgery Would argue for early consideration of penile prostheses in a large percentage of men presenting with PD and ED 2013 MFMER slide-35
Challenges with Clinical Measures of ED IIEF Curvature precludes use of IIEF in large % Hypothetical questioning on rigidity if no PD present How To Measure Complex ED? Variable rigidity along shaft (proximal / distal to hourglass) Buckling / hinge Secondary Impairments Penile pain 2013 MFMER slide-36
Why Not Try Surgical Correction of PD, then Prosthesis if ED? 2013 MFMER slide-37
Sensory Changes Sensory changes after incision & grafting 1 N=63, 14 mo follow-up, 15 mo PD duration Mean pre-op curvature 64 Sensation loss: 1 mo (21%), 6 mo (8%), 12 mo (3%) 1 - Mulhall JM, et al: AUA 2014 Abstract PD20-07. 2013 MFMER slide-38
Plication Outcomes N= (f/u mo) Author (Year) Straight (%) ED (%) Sense (%) Length (%) Satisfied (%) Essed Schroeder / TAP 19 (40) Leonardo (2012) 75 48 (<24) Dugi (2010) 2 0 93 26 (12) Kim (2008) 65 11 19 69 65 15 (21) Kadioglu (2008) 87 95 61 (72) Taylor (2008) 87 19 31 18 82 76 (71) Paez (2007) 42 61 66 68 (29) Greenfield (2006) 99 7.3 4 99 28 (30) Van der Horst (2004) 100 28 74 78 44 (49) Chahal (2001) 29 36 32 90 21 (30) Schultheiss (2000) 57 3 46 16-dot Plication 132 (31) Gholami (2002) 85 6 6 41 96 Total Plication 74 19 27 43 90 Total Corporoplasty 89 2 8 24 82 2013 MFMER slide-39
Summary ED is common in PD men The natural history of ED in PD men appears similar to those with ED alone Current surgical algorithms suggest placement of penile prostheses in men with ED unresponsive to PDE5 inhibitors Predictors for ED after PD surgery include: Age >55-60, VOD, decreased sexual activity, curvature >60, ventral grafts, grafts >3 cm, Egydio technique 2013 MFMER slide-43
Summary - Unresolved Issues Reliable and reproducible measures to quantify erectile function prior to PD surgery Reliable and reproducible measures to stratify severity of PD Current algorithm: Over simplified, lacks role for Xiaflex Fail to distinguish plication/corporoplasty and incision/excision and grafting Inadequate stratification of men at risk for ED after PD surgery Improved algorithm would likely greatly increase the role of penile prostheses 2013 MFMER slide-44
Thank You 2013 MFMER slide-45