New England Section of the American Urological Association

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Trends in Penile Prosthesis Implantation and Predictors of Removal
Kai Li, MD1; Eileen Brandes, MD2; Steven L. Chang, MD3; Benjamin I. Chung, MD4; Ye Wang, BS3; Jairam R. Eswara, MD3
1Massachusetts General Hospital, Boston, MA; 2Harvard Medical School, Boston, MA; 3Brigham and Women's Hospital, Boston, MA; 4Stanford Hospital, Stanford, CA

Background:
Implantation of penile prosthesis is a definitive treatment option for erectile dysfunction and Peyronie's disease. The two most common complications leading to prosthesis removal are mechanical and infectious. In this study, we examine the trends in implantation of malleable and inflatable penile prosthesis in the United States as well as cost of prosthesis removal. We also examine the factors predicting removal stratified by indication.
Methods:
The patient population was from the Premier Perspective Database between 2003-2015 and consisted of a weighted estimate of 5085 implants performed at over 700 U.S. hospitals. Among these weighted implants, we compared the proportion of inflatable vs malleable prosthetic placements by year. We then compared the cohort of penile prosthesis removals to the cohort of penile prosthesis implants who were never explanted. Cost analysis was performed between prosthesis explants due to infectious versus mechanical complication. Multivariate analysis was performed on covariates which predicted prosthesis removal, stratified by indication for removal.
Results:
Between 2003-2015 we observed a stable trend in the proportion of inflatable vs malleable implants. The proportion of malleable implants ranged from 0.97% - 19.52% and inflatable implants from 80.48% - 99.03%. There was a weighted estimate of 3317 total explants. 1930 explants (49.27%) were due to infectious complications, 771 explants (28.97%) were due to mechanical complications, and the remainder due to unknown indications. Median hospital cost for all explants was $11,237. The median cost of an explant due to infection was not significantly different from removal due to mechanical complication ($11,657 vs $8,481, p=0.10). On multivariate analysis, predictors of removal due to infectious complications included Charlson Comorbidity Index (CCI) ≥ 2, teaching status of the hospital, low surgeon volume, uncomplicated diabetes, complicated diabetes, and HIV status. Predictors of removal due to mechanical complications included CCI ≥ 2, teaching status of the hospital, and uncomplicated diabetes. Predictors of removal for all explants as a group included CCI ≥ 2, teaching status of the hospital, low surgeon volume, uncomplicated diabetes, complicated diabetes, HIV status. Other factors examined that did not reach statistical significance included race, marital status, insurance, hospital bedsize, rural versus urban hospital, low versus high volume hospital, and chronic steroid use (Table 1).
Conclusions:
This is a large nationwide based study demonstrating the stable trend in the proportion of inflatable vs malleable implants over the last 13 years. We also identified predictors of prosthesis removal which are valuable to patient counseling. Even though causality for any of the predictors cannot be substantiated, it provides insight on factors which may impact rates of penile prosthesis removal.
Table 1. Comparison of cohorts of penile prosthesis explants to control group of never-explanted patients.

Parametern (%)Group 1 vs ControlGroup 2 vs ControlGroup 3 vs Control
Control: Never explantedGroup 1: Explanted- infectionGroup 2:
Explanted-mechanical
Group 3: Explanted-AllAdjusted OR (95% CI)P-value Adjusted OR (95% CI)P-value Adjusted OR (95% CI)P-value
Total50851930 (49.27)771 (28.97)3317 (100)
Age (year), mean SD66 871 1174 1072 11
Race
White3183 (62.6)1214 (62.9)555 (71.96)2130 (64.21)ReferenceReferenceReference
Black734 (14.43)289 (14.99)44 (5.69)459 (13.83)1.05 (0.63-1.75)0.86020.32 (0.13-0.82)0.01791.14 (0.72-1.82)0.5713
Hispanic / Other1168 (22.97)426 (22.08)172 (22.35)729 (21.97)1.1 (0.64-1.87)0.740.74 (0.36-1.52)0.40941.03 (0.67-1.6)0.8855
Marital Status
Married3077 (60.71)1027 (53.21)357 (46.28)1702 (51.31)ReferenceReferenceReference
Single or other1991 (39.29)903 (46.77)414 (53.72)1615 (48.69)1.15 (0.8-1.66)0.43761.32 (0.68-2.56)0.40461.27 (0.93-1.74)0.1277
Charlson Comorbidity Index
02384 (51.43)600 (34.39)152 (23.66)922 (31.56)ReferenceReferenceReference
11379 (29.75)392 (22.47)113 (17.7)674 (23.06)1.07 (0.67-1.71)0.76441.04 (0.52-2.08)0.90421.14 (0.77-1.67)0.5181
>= 2871 (18.79)753 (43.15)375 (58.64)1326 (45.38)2.64 (1.67-4.17)<.00015.93 (2.87-12.27)<.00012.94 (1.98-4.37)<.0001
Insurance
Medicare/Medicaid3352 (65.92)1537 (79.64)687 (89.11)2716 (81.88)ReferenceReferenceReference
Other1733 (34.08)393 (20.36)84 (10.89)601 (18.12)1.23 (0.71-2.11)0.45641 (0.45-2.22)0.99911.16 (0.75-1.81)0.5098
Hospital Bedsize
<3001410 (27.73)581 (30.08)245 (31.75)1031 (31.08)ReferenceReferenceReference
300 4992285 (44.94)834 (43.19)318 (41.24)1358 (40.94)1.21 (0.73-2.02)0.46241.47 (0.67-3.24)0.33521.17 (0.75-1.81)0.4845

≥5001390 (27.34)516 (26.72)208 (27.01)929 (27.99)1.32 (0.67-2.61)0.4252.55 (1.1-5.92)0.02941.49 (0.83-2.67)0.1813
Teaching Status
No3438 (67.61)1482 (76.79)625 (81.1)2556 (77.06)ReferenceReferenceReference
Yes1647 (32.39)448 (23.22)146 (18.9)761 (22.94)0.54 (0.32-0.92)0.02240.43 (0.2-0.92)0.03070.61 (0.39-0.96)0.0317
Location
Urban4878 (95.93)1868 (96.79)748 (96.94)3221 (97.11)ReferenceReferenceReference
Rural206 (4.06)62 (3.23)24 (3.06)97 (2.92)0.82 (0.37-1.86)0.63670.75 (0.19-2.92)0.67460.68 (0.33-1.42)0.3065
Annual hospital volume (no. of cases)
Low (< 7)4394 (86.41)1782 (92.33)722 (93.66)3109 (93.73)ReferenceReferenceReference
High (>= 7)691 (13.58)147 (7.64)49 (6.34)209 (6.29)0.64 (0.27-1.52)0.31090.37 (0.11-1.22)0.10210.56 (0.23-1.36)0.198
Annual surgeon volume (no. of cases)
Low (< 5)4552 (89.52)1874 (97.1)750 (97.2)3236 (97.56)ReferenceReferenceReference
High (>= 5)533 (10.49)56 (2.9)22 (2.8)82 (2.46)0.23 (0.09-0.6)0.00280.63 (0.22-1.79)0.38030.28 (0.14-0.59)0.0009
Diabetes mellitus
No4361 (94.09)1510 (86.53)569 (88.91)2516 (86.11)ReferenceReferenceReference
Uncomplicated48 (1.04)58 (3.34)21 (3.29)126 (4.31)6.21 (1.28-30.02)0.02345.5 (1.76-17.18)0.00357.42 (1.93-28.56)0.0037
Complicated225 (4.86)177 (10.13)50 (7.8)280 (9.6)2.35 (1.24-4.45)0.00862.57 (0.97-6.81)0.05692.14 (1.2-3.8)0.0097
HIV
No5082 (99.94)1922 (99.59)771 (100)3310 (99.79)ReferenceReferenceReference
Yes3 (0.05)8 (0.4)0 (0)8 (0.23)19.99 (3.25-122.93)0.0013NANA15.98 (2.86-89.48)0.0017
Long-term steroid use
No5080 (99.9)1912 (99.07)771 (100)3299 (99.46)ReferenceReferenceReference
Yes5 (0.1)18 (0.93)0 (0)18 (0.54)NANANANA9.71 (0.21-448.72)0.2444


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