- Email: [email protected]
Hospital‐Based Trends in Penile Prosthetic Surgery
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ORIGINAL RESEARCH—SURGERY Hospital-Based Trends in Penile Prosthetic Surgery Hossein S. Mirheydar, MD,* Kerrin L. Palazzi, MPH,* J. Kellogg Parsons, MD, MHS,*†‡ David Chang, MPH,† and Tung-Chin Hsieh, MD*†‡ *Department of Urology, UC San Diego Health System, San Diego, CA, USA; †Department of Surgery, University of California, San Diego, La Jolla, CA, USA; ‡VA San Diego Healthcare System, San Diego, CA, USA DOI: 10.1111/jsm.12829
ABSTRACT
Introduction. We examined national and regional trends in hospital-based penile prosthetic surgery and identified patient-specific factors predicting receipt of inflatable vs. semi-rigid penile prostheses. Aims. To improve our understanding of the surgical treatment for erectile dysfunction (ED). Methods. We utilized the Nationwide Inpatient Sample (NIS) from 1998 to 2010 in the United States and the California Office of Statewide Health Planning and Development (OSHPD) database from 1995 to 2010. Total number of penile implants performed and proportions of inflatable vs. semi-rigid prosthesis were examined. Multivariate analysis (MVA) was performed to identify factors associated with selection of inflatable vs. semi-rigid prostheses. Main Outcome Measures. Primary outcome measure is the total number of hospital-based penile prosthetic surgeries performed in the United States over a 12-year period (1998–2010). Secondary outcome measures include proportion of inflatable and semi-rigid prosthesis implantations and factors influencing receipt of different prostheses. Results. We identified 53,967 penile prosthetic surgeries in the NIS; annual number implanted decreased from 4,703 to 2,338. Inflatable prostheses incurred higher costs but had a similar length of stay (LOS). In MVA, Caucasian race, Peyronie’s disease, and private insurance were independently associated with receipt of an inflatable prosthesis. We identified 7,054 penile prostheses in OSHPD; annual number implanted decreased from 760 to 318. The proportion of inflatable prostheses increased significantly from 78.4% to 88.4% between 2001 and 2010. Inflatable prostheses incurred higher costs but had similar median LOS. In MVA, Caucasians and men without spinal cord injury were more likely to receive inflatable prosthesis. Conclusion. Hospital-based penile prosthetic surgery has decreased substantially both nationwide and in California. In the United States, Caucasian race, Peyronie’s disease, and private insurance were independently associated with receipt of an inflatable penile prosthesis. California population data correlated with national trends and can be utilized to further study surgical management of ED. Mirheydar HS, Palazzi KL, Parsons JK, Chang D, and Hsieh T-C. Hospital-based trends in penile prosthetic surgery. J Sex Med 2015;12:1092–1098. Key Words. Erectile Dysfunction; Penile Prosthetic Surgery; Population Trends
Introduction
E
rectile dysfunction (ED) is estimated to affect up to 30 million men in the United States [1]. Available treatment options include vacuum erection device, phosphodiesterase type 5 (PDE5) inhibitors, intracavernosal injections, and penile prosthetic surgery. Satisfaction rates of men under-
J Sex Med 2015;12:1092–1098
going penile implants are reportedly quite high, as are partner satisfaction rates [2–4]. Continued improvement in the design of antibiotic coated penile implants has been associated with reduced infection rates of such implants [5–7]. Constant refinement in the development of antibiotic coated penile implants and improvements in surgical technique have led to decreased © 2015 International Society for Sexual Medicine
Trends in Surgical Treatment of Erectile Dysfunction infection rates [5,6]. High patient and partner satisfaction regarding penile implants have consistently been reported to be superior to both oral PDE5 inhibitors and intracavernosal injectable agents [8]. The awareness of ED has improved since FDA approval of alprostadil in 1997 and of Viagra in 1998, which led to an increase in the number of men seeking treatment. Furthermore, many hypothesized that the number of men seeking penile prosthetic surgery would also increase in the future; however, no validated administrative data sets have specifically examined this hypothesis. Prior trends in the utilization of penile prosthetic surgery have been reported using Healthcare Cost and Utilization Project (HCUP) data, single institution, single surgeon, or industrysponsored data [1,9,10]. No studies to date have included validated national or regional population data to report modern trends in the implantation of penile prostheses. We examined both national and California data to report hospital-based trends in surgical management of ED. Methods
The Nationwide Inpatient Sample (NIS) and The State of California Office of Statewide Health Planning and Development (OSHPD) data sets were utilized to study trends of penile prosthesis surgery. Both data sets were utilized to capture any surgery performed in a hospital, regardless of whether they are admitted overnight or whether they are admitted for only a 23-hour observation. The NIS database is part of the HCUP, sponsored by the Agency for Healthcare Research and Quality, and includes 20% of U.S, community hospitals. Hospital records include clinical and resource use information typically available from discharge abstracts. Hospital and discharge weights are provided to generate national estimates. Discharges from 1998 through 2010 were included in the analysis. All data were weighted using discharge level values, based on the relative proportion of the total U.S. hospital patient population accounted for by that record, to produce national estimates. We identified adult patients (≥50 years old) with International Classification of Diseases, Ninth Revision (ICD-9) procedural codes for penile prosthesis implant from 1998 through 2010. Similarly, the OSHPD was used to capture California state trends in penile implantation between 1995
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and 2010. OSHPD provides a 100% sample of surgeries performed at nonfederal hospitals in California. Penile prosthetic surgeries were captured using ICD-9 codes in patients ≥50 years old. In both data sets, the primary end point was the total number of prosthetic surgeries performed and the proportion of inflatable vs. semi-rigid prosthesis, which was calculated annually. Binary logistic regression analysis was used to examine patient factors associated with the selection of inflatable vs. semi-rigid penile prosthesis. Using both NIS and OSPHD data sets, patient age, race, gender, insurance type (Medicare, Medicaid, private), Charlson comorbidity index score, comorbidities (hypertension, diabetes mellitus, obesity), history of Peyronie’s disease, history of spinal cord injury, history of prostate cancer, and hospital cost were abstracted. Comorbidities were documented using records from ICD-9 coding, and Appendix S1 summarizes the ICD-9 codes utilized. Chi-squared and Mann–Whitney U-tests were used to compare demographics, disease-specific variables, comorbidities and cost between inflatable and semi-rigid implants. Linear regression was used to compare rates of surgery over time, P value < 0.05 was considered significant. Results
Between 1998 and 2010, there was a significant decrease in the total number of hospital-based penile prosthetic surgeries performed in the United States (Figure 1). The number of cases decreased from 4,703 (1998) to 2,338 (2010). The proportion of inflatable penile prosthetic surgery significantly increased during this same time period (Table 1). In univariate analysis (Table 2), the proportion of Caucasians, men with Peyronie’s disease, or men with private insurance was higher among those receiving inflatable penile prosthesis. In contrast, the proportion of men with spinal cord injuries was significantly higher in semi-rigid prosthesis group. No differences were observed in rates of hypertension, diabetes mellitus, obesity, coronary artery disease, peripheral vascular disease or prostate cancer among patients receiving inflatable vs. semi-rigid prosthesis in the hospital setting. Between 1995 and 2010, there was also a significant decrease in the total number of penile implants performed in California hospitals (Figure 2). The proportion of inflatable penile implants significantly increased (Table 3). In uniJ Sex Med 2015;12:1092–1098
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Mirheydar et al.
Figure 1 Number of implants over time (NIS)
variate analysis (Table 4), proportions of Caucasian men, men without diabetes or hypertension, and men without obesity were all higher among men receiving inflatable implants. Similarly, men with higher Charlson comorbidity index were more likely to receive semi-rigid implant. No differences were observed in rates of hyperlipidemia, coronary artery disease, peripheral vascular disease, Peyronie’s disease, or prostate cancer among patients receiving inflatable vs. semi-rigid implants in a hospital in California. Nationally, the median charges associated with the inflatable penile implants were significantly higher than semi-rigid implants despite having the same median length of stay (Table 2). Similarly in California, the median hospital charges were significantly higher in men receiving inflatable vs. semi-rigid penile implants (Table 4). Multivariate analysis using OSHPD data (Table 5) showed that Caucasian race and ED not secondary to spinal cord injury were both independently associated with receipt of an inflatable penile implant. Multivariate analysis using NIS data (Table 6) showed that age range (70–79 compared with 50–59), private insurance, and Peyronie’s disease were all patient factors independently associated with receipt of an inflatable penile implant. J Sex Med 2015;12:1092–1098
Discussion
We observed that in both California and nationally, the total number of hospital-based penile prosthetic surgeries performed decreased between 1995 and 2010, while the proportion of inflatable prostheses increased between 2001 and 2010. These data are important because they highlight the modern trends of ED surgery performed in hospitals. The trends we observed are different from those reported previously [10]. Using industry
Table 1
Implants by year (NIS)
Year
Total implants
Semi-rigid penile prosthesis
IPP
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Total
4,703 4,692 5,396 5,486 4,802 4,261 3,878 4,102 4,189 3,599 3,239 3,282 2,338 53,967
571 578 728 567 521 501 498 292 369 293 202 194 173 5,488
4,133 4,114 4,668 4,919 4,280 3,760 3,380 3,810 3,819 3,305 3,038 3,088 2,165 48,479
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Trends in Surgical Treatment of Erectile Dysfunction Table 2
Semi-rigid vs. IPP (NIS) Semi-rigid (n = 5,488)
Age 50–59 60–69 70–79 80+ Race Caucasian AA Hispanic Asian Other Insurance Commercial Medicare Medicaid Other/limited DM HTN Hyperlipidemia Obesity PVD EDspinal Peyronies Prostate Ca Median LOS (IQR), days Median charges (IQR), $ Charlson 0–2 3+ Explant
IPP (n = 48,479)
P value
Number 1,678 2,324 1,280 206
% 30.6 42.3 23.3 3.8
Number 13,398 20,768 12,529 1,784
% 27.6 42.8 25.8 3.7
2,570 1,009 625 51 1,233
46.8 18.4 11.4 0.9 22.5
26,268 6,334 3,815 310 11,754
54.2 13.1 7.9 0.6 24.2
35.7 57 3 4.2 16.5 11.3 17.4 5.0 3.4 0.6 1.8 5.6
18,148 28,140 671 1,521 7,646 5,735 8,392 2229 1,536 118 1,803 1,913 1 (1–2) 29,720 (21,591–40,994)
37.4 58.0 1.4 3.1 15.8 11.8 17.3 4.6 3.2 0.2 3.7 3.9
95.1 4.9 2.6
46,332 2,148 592
95.6 4.4 1.2
0.127
<0.001
0.005 1,958 3,130 167 233 905 621 957 276 187 34 100 305 1 (1–2) 20,663 (13,183–30,311) 5,220 268 142
data, Wiser et al. reported a global increase of 8% annually in the total volume of penile implants performed between 2005 and 2011, with the largest increases observed in the United States [10]. Many factors likely contribute to the differences in the observations. First, we utilized an
0.541 0.637 0.930 0.591 0.732 0.030 0.001 0.210 0.593 <0.001 0.491 <0.001
administrative claims-based database independently maintained by the state of California (OSHPD) and HCUP that only capture penile prosthetic surgery performed in a hospital. All surgeries performed in outpatient ambulatory surgery centers were not captured. It is possible that
Figure 2 Number of implants over time (OSHPD)
J Sex Med 2015;12:1092–1098
1096 Table 3
Mirheydar et al. Implants by year (OSHPD)
Year
Total implants
Semi-rigid penile prosthesis
IPP
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Total
760 699 627 416 457 454 533 535 491 420 380 390 354 354 329 318 7,517
173 145 139 76 87 100 115 96 85 64 47 41 35 35 43 37 1,318
587 554 488 340 370 354 418 439 406 356 333 349 319 319 286 281 6,199
industry-based data included both ambulatory and hospital-based penile prosthetic surgeries, and thus accounts for differences in our results. However, the proportion of surgeries performed
Table 4
in outpatient surgery centers remains unknown and warrants investigation in the future. The practice pattern of high volume vs. low volume implanters is clearly different but not well defined. It is possible that our observation excluded high volume implanters more likely to perform prosthetic surgeries in ambulatory surgery centers. Future studies to better understand the different practice patterns have the potential to identify appropriate patient selection for surgical planning (i.e., candidates for ambulatory setting). Furthermore, our results mirror those observed by Jhaveri et al. in North Carolina between 1988 and 1993 [11]. In this claims-based analysis of 151 North Carolina hospitals, the total number of penile prosthetic surgeries performed decreased significantly over the 6-year time period. The authors hypothesized that decreasing reimbursement over time and increased utilization of medical therapy may contribute to their observation, and also may explain the decreased number of penile implants performed in the United States [12]. In California, the median cost associated with inflatable penile prosthesis ($40,941) was signifi-
Semi-rigid vs. IPP (OSHPD) (n = 1,321)
Age 50–59 60–69 70–79 80+ Race Caucasian AA Hispanic Asian Other Insurance Commercial Medicare Medicaid Other/limited DM HTN Hyperlipidemia Obesity CAD PVD EDspinal Peyronies Prostate Ca Median LOS (IQR), days Median charges (IQR), $ Charlson 0–2 3+ Explant
J Sex Med 2015;12:1092–1098
IPP (n = 6,183)
P value 0.104
334 (25.3%) 547 (41.4%) 391 (29.6%) 49 (3.7%)
1,405 (22.7%) 2,580 (41.7%) 1,905 (30.8%) 293 (4.7%)
653 (70.4%) 105 (11.3%) 108 (11.7%) 21 (2.3%) 40 (4.3%)
3,556 (77.7%) 329 (7.2%) 363 (7.9%) 63 (1.4%) 266 (5.8%)
<0.001
<0.001 296 (37.6%) 447 (56.8%) 17 (2.2%) 27 (3.4%) 440 (33.3%) 608 (46.0%) 201 (15.2%) 90 (6.8%) 1 (0.1%) 44 (3.3%) 10 (0.76%) 22 (1.7%) 358 (27.1%) 1 (1–2) 19,248 (0–34,612) 1,247 (94.4%) 74 (5.6%) 19 (1.4%)
1,573 (37.3%) 2,524 (59.9%) 27 (0.6%) 89 (2.1%) 1,735 (28.1%) 2,640 (42.7%) 846 (13.7%) 290 (4.7%) 13 (0.2%) 160 (2.6%) 9 (0.2%) 144 (2.3%) 1,686 (27.3%) 1 (1–2) 40,941 (27,809–59,539) 5,916 (95.7%) 267 (4.3%) 60 (1.0%)
<0.001 0.027 0.144 0.001 0.304 0.132 <0.001 0.137 0.901 0.127 <0.001 0.042
0.130
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Trends in Surgical Treatment of Erectile Dysfunction Table 5
Odds of IPP implantation (OSHPD)
Caucasian ED from Spinal
OR
95% CI
P value
1.383 0.195
1.227 to 1.558 0.079 to 0.482
<0.001 <0.001
cantly more than the cost of semi-rigid implant ($19,248), a trend mirrored in the nationwide analysis ($29,720 vs. $20,663). This cost analysis was consistent with that performed by Buch et al. demonstrating the increased cost associated with inflatable compared with malleable penile implants [13]. Interestingly, in California, men with spinal cord injuries were significantly more likely to receive a semi-rigid or malleable penile implant. This finding reflects the known utility of malleable penile implants in managing both impotence and the urinary incontinence commonly observed in spinal cord injury patients [14]. Specifically, the semi-rigid implant in these patients facilitates urinary drainage with the use of external condom catheters in men with penile retraction, and thus not only provides improved continence but also treats impotence. Zermann et al. reported excellent resolution of urinary drainage problems as well as treatment of impotence in patients with spinal cord injuries with long-term follow-up [15]. However, it has also been shown that spinal cord injury patients might be better served with inflatable prosthesis due to concern for erosion [15]. Peyronie’s disease is known to be associated with concomitant ED [16]. Patients with Peyronie’s disease were over two times more likely to receive an inflatable penile prosthesis in the United States. A recent study by Chung et al. demonstrated that penile prosthetic surgery can be safely performed concurrently with curvature correction procedures and is associated with high patient satisfaction rates [17]. This finding reflects the previous report that inflatable devices can lead to higher functional satisfaction and lower rates of persistent penile curvature deformity compared with semi-rigid devices [18,19]. In addition, Caucasian race was independently associated with receipt of inflatable penile prosthesis, highlighting racial disparities in the surgical management of ED. Racial variation in the selection of penile prosthetic surgery was also described recently using a California administrative data set by Grewal et al. in which the authors demonstrated that African-American men were more likely to receive a semi-rigid implant [20]. Lower socioeco-
nomic status may account for selection of less expensive, and thus, semi-rigid implant; however, these findings highlight disparities in care warranting further investigation. In the United States, older men (ages 70 to 79) were significantly more likely to receive an inflatable penile prosthesis than younger men (ages 50 to 59). This was a surprising finding because one would anticipate that elderly men may have more difficulty handling the scrotal pump associated with inflatable prostheses, and thus prefer malleable semi-rigid implants because of their ease of use. Our finding that men aged 70–79 were more likely to receive an inflatable prosthesis compared with younger men was unexpected and warrants further investigation.
Limitations Limitations of the NIS are inherent to this data set—it relies on accurate physician coding and provides only a 20% estimate of all surgeries performed annually in the United States. There is also a trend toward penile prosthesis surgery in an outpatient setting; however, there are currently no data summarizing the distribution of penile prosthetic surgery performed in hospitals vs. in ambulatory surgery centers. Limitations of the OSHPD are that it does not include same-day surgery center data and also relies on accurate physician coding. Notwithstanding the above limitations, this study is important in that it quantitatively demonstrates a decrease in penile prosthesis surgery over the last 10–15 years in both California and nationally among patients undergoing surgery in a hospital, including patients who are admitted for 23-hour stays or discharged from the hospital after undergoing surgery. Table 6 Logistic regression with odds of IPP implantation (NIS)
Age (50–59 = ref) 60–69 70–79 80–89 Insurance (commercial = ref) Medicare Medicaid Other/limited Caucasian Charlson comorbidity index (CCI) ≥ 3 (CCI 0–2 = ref) Spinal cord injury Peyronies Prostate cancer
OR
95%CI
P value
1.159 1.278 1.126
0.993 1.074 0.780
1.354 1.522 1.627
0.062 0.006 0.525
0.881 0.461 0.688 1.303 1.033
0.753 0.290 0.410 1.080 0.746
1.040 0.730 1.140 1.570 1.430
0.137 0.001 0.149 0.005 0.846
0.462 2.038 0.715
0.188 1.308 0.392
1.134 3.176 1.304
0.092 0.002 0.274
J Sex Med 2015;12:1092–1098
1098 Conclusion
This is the largest comprehensive analysis of modern trends in hospital-based penile prosthetic surgery. We observed an overall decrease in penile prosthetic surgery and an increase in the proportion of inflatable prostheses utilization. Future studies are needed to better understand the observed hospital-based trends and racial disparities in penile prosthetic surgery, and more importantly to quantify the distribution of penile prosthetic surgery performed in ambulatory surgery centers vs. hospitals. The California population database appeared to correlate with national trends and might be utilized in future studies. Corresponding Author: Tung-Chin Hsieh, MD, Department of Urology, UC San Diego Health System, 200 W Arbor Drive #8897, San Diego, CA 92103-8897, USA. Tel: (619) 543-2009; Fax: (619) 543-6573; E-mail: [email protected] Conflict of Interest: Tung-Chin Hsieh is a consultant for American Medical System. Statement of Authorship
Category 1 (a) Conception and Design Hossein S. Mirheydar; J. Kellogg Parsons; TungChin Hsieh (b) Acquisition of Data Kerrin L. Palazzi; David Chang (c) Analysis and Interpretation of Data Kerrin L. Palazzi; David Chang; Tung-Chin Hsieh
Category 2 (a) Drafting the Article Hossein S. Mirheydar; Kerrin L. Palazzi (b) Revising It for Intellectual Content Tung-Chin Hsieh; David Chang; J. Kellogg Parsons
Category 3 (a) Final Approval of the Completed Article Tung-Chin Hsieh References 1 Wessells H, Joyce GF, Wise M, Wilt TJ. Erectile dysfunction. J Urol 2007;177:1675–81. 2 Bernal RM, Henry GD. Contemporary patient satisfaction rates for three-piece inflatable penile prostheses. Adv Urol 2012;2012:1–5. 3 Brinkman MJ, Henry GD, Wilson SK, Delk JR II, Denny GA, Young M, Cleves MA. A survey of patients with inflatable penile prostheses for satisfaction. J Urol 2005;174:253–7.
J Sex Med 2015;12:1092–1098
Mirheydar et al. 4 Vakalopoulos I, Kampantais S, Ioannidis S, Laskaridis L, Dimopoulos P, Toutziaris C, Koptsis M, Henry GD, Katsikas V. High patient satisfaction after inflatable penile prostheses implantation correlates with female partner satisfaction. J Sex Med 2013;10:2774–81. 5 Mandava SH, Serefoglu EC, Freier MT, Wilson SK, Hellstrom WJ. Infection retardant coated inflatable penile prostheses decrease the incidence of infection: A systematic review and meta-analysis. J Urol 2012;188:1855–60. 6 Eid JF, Wilson SK, Cleves M, Salem EA. Coated implants and “no touch” surgical technique decreases risk of infection in inflatable penile prosthesis implantation to 0.46%. Urology 2012;79:1310–5. 7 Selph JP, Carson CC III. Penile prosthesis infection: Approaches to prevention and treatment. Urol Clin North Am 2011;38:227–35. 8 Rajpurkar A, Dhabuwala CB. Comparison of satisfaction rates and erectile function in patients treated with sildenafil, intracavernous prostaglandin E1 and penile implant surgery for erectile dysfunction in urology practice. J Urol 2003; 170:159–63. 9 Stanley GE, Bivalacqua TJ, Hellstrom WJ. Penile prosthetic trends in the era of effective oral erectogenic agents. South Med J 2000;93:1153–6. 10 Wiser H, Kottwitz M, Wilson S, Tobias K. Interesting trends of penile prosthesis usage. J Urol 2013;189:e685. 11 Jhaveri FM, Rutledge R, Carson CC. Penile prosthesis implantation surgery: A statewide population based analysis of 2354 patients. Int J Impot Res 1998;10:251–4. 12 Mulcahy J. Male sexual function: A guide to clinical management. 2nd edition. Totowa, NJ: Humana Press; 2007. 13 Buch JP, Zorn BH, Taylor RJ. Cost-benefit analysis of pharmacologic erection program (PEP) vs. penile prosthesis. Urology 1991;37:116–8. 14 Kim YD, Yang SO, Lee JK, Jung TY, Shim HB. Usefulness of a malleable penile prosthesis in patients with a spinal cord injury. Int J Urol 2008;15:919–23. 15 Zermann DH, Kutzenberger J, Sauerwein D, Schubert J, Loeffler U. Penile prosthetic surgery in neurologically impaired patients: Long-term followup. J Urol 2006;175(3 Pt 1):1041–4. discussion 1044. 16 Pryor J, Akkus E, Alter G, Jordan G, Lebret T, Levine L, Mulhall J, Perovic S, Ralph D, Stackl W. Peyronie’s disease. J Sex Med 2004;1:110–5. 17 Chung PH, Scott JF, Morey AF. High patient satisfaction of inflatable penile prosthesis insertion with synchronous penile plication for erectile dysfunction and Peyronie’s disease. J Sex Med 2014;11:1593–8. 18 Kadioglu A, Kucukdurmaz F, Sanli O. Current status of the surgical management of Peyronie’s disease. Nat Rev Urol. 2011;8:95–106. 19 Carson CC, Levine LA. Outcomes of surgical treatment of Peyronie’s disease. BJU Int 2014;113:704–13. 20 Grewal S, Vetter J, Brandes SB, Strope SA. A Population-based analysis of contemporary rates of reoperation for penile prosthesis procedures. Urology 2014;84:112–6.
Supporting Information Additional Supporting Information may be found in the online version of this article at the publisher’s website: Appendix S1 Summary of ICD-9 codes used.
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ORIGINAL RESEARCH—SURGERY Hospital-Based Trends in Penile Prosthetic Surgery Hossein S. Mirheydar, MD,* Kerrin L. Palazzi, MPH,* J. Kellogg Parsons, MD, MHS,*†‡ David Chang, MPH,† and Tung-Chin Hsieh, MD*†‡ *Department of Urology, UC San Diego Health System, San Diego, CA, USA; †Department of Surgery, University of California, San Diego, La Jolla, CA, USA; ‡VA San Diego Healthcare System, San Diego, CA, USA DOI: 10.1111/jsm.12829
ABSTRACT
Introduction. We examined national and regional trends in hospital-based penile prosthetic surgery and identified patient-specific factors predicting receipt of inflatable vs. semi-rigid penile prostheses. Aims. To improve our understanding of the surgical treatment for erectile dysfunction (ED). Methods. We utilized the Nationwide Inpatient Sample (NIS) from 1998 to 2010 in the United States and the California Office of Statewide Health Planning and Development (OSHPD) database from 1995 to 2010. Total number of penile implants performed and proportions of inflatable vs. semi-rigid prosthesis were examined. Multivariate analysis (MVA) was performed to identify factors associated with selection of inflatable vs. semi-rigid prostheses. Main Outcome Measures. Primary outcome measure is the total number of hospital-based penile prosthetic surgeries performed in the United States over a 12-year period (1998–2010). Secondary outcome measures include proportion of inflatable and semi-rigid prosthesis implantations and factors influencing receipt of different prostheses. Results. We identified 53,967 penile prosthetic surgeries in the NIS; annual number implanted decreased from 4,703 to 2,338. Inflatable prostheses incurred higher costs but had a similar length of stay (LOS). In MVA, Caucasian race, Peyronie’s disease, and private insurance were independently associated with receipt of an inflatable prosthesis. We identified 7,054 penile prostheses in OSHPD; annual number implanted decreased from 760 to 318. The proportion of inflatable prostheses increased significantly from 78.4% to 88.4% between 2001 and 2010. Inflatable prostheses incurred higher costs but had similar median LOS. In MVA, Caucasians and men without spinal cord injury were more likely to receive inflatable prosthesis. Conclusion. Hospital-based penile prosthetic surgery has decreased substantially both nationwide and in California. In the United States, Caucasian race, Peyronie’s disease, and private insurance were independently associated with receipt of an inflatable penile prosthesis. California population data correlated with national trends and can be utilized to further study surgical management of ED. Mirheydar HS, Palazzi KL, Parsons JK, Chang D, and Hsieh T-C. Hospital-based trends in penile prosthetic surgery. J Sex Med 2015;12:1092–1098. Key Words. Erectile Dysfunction; Penile Prosthetic Surgery; Population Trends
Introduction
E
rectile dysfunction (ED) is estimated to affect up to 30 million men in the United States [1]. Available treatment options include vacuum erection device, phosphodiesterase type 5 (PDE5) inhibitors, intracavernosal injections, and penile prosthetic surgery. Satisfaction rates of men under-
J Sex Med 2015;12:1092–1098
going penile implants are reportedly quite high, as are partner satisfaction rates [2–4]. Continued improvement in the design of antibiotic coated penile implants has been associated with reduced infection rates of such implants [5–7]. Constant refinement in the development of antibiotic coated penile implants and improvements in surgical technique have led to decreased © 2015 International Society for Sexual Medicine
Trends in Surgical Treatment of Erectile Dysfunction infection rates [5,6]. High patient and partner satisfaction regarding penile implants have consistently been reported to be superior to both oral PDE5 inhibitors and intracavernosal injectable agents [8]. The awareness of ED has improved since FDA approval of alprostadil in 1997 and of Viagra in 1998, which led to an increase in the number of men seeking treatment. Furthermore, many hypothesized that the number of men seeking penile prosthetic surgery would also increase in the future; however, no validated administrative data sets have specifically examined this hypothesis. Prior trends in the utilization of penile prosthetic surgery have been reported using Healthcare Cost and Utilization Project (HCUP) data, single institution, single surgeon, or industrysponsored data [1,9,10]. No studies to date have included validated national or regional population data to report modern trends in the implantation of penile prostheses. We examined both national and California data to report hospital-based trends in surgical management of ED. Methods
The Nationwide Inpatient Sample (NIS) and The State of California Office of Statewide Health Planning and Development (OSHPD) data sets were utilized to study trends of penile prosthesis surgery. Both data sets were utilized to capture any surgery performed in a hospital, regardless of whether they are admitted overnight or whether they are admitted for only a 23-hour observation. The NIS database is part of the HCUP, sponsored by the Agency for Healthcare Research and Quality, and includes 20% of U.S, community hospitals. Hospital records include clinical and resource use information typically available from discharge abstracts. Hospital and discharge weights are provided to generate national estimates. Discharges from 1998 through 2010 were included in the analysis. All data were weighted using discharge level values, based on the relative proportion of the total U.S. hospital patient population accounted for by that record, to produce national estimates. We identified adult patients (≥50 years old) with International Classification of Diseases, Ninth Revision (ICD-9) procedural codes for penile prosthesis implant from 1998 through 2010. Similarly, the OSHPD was used to capture California state trends in penile implantation between 1995
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and 2010. OSHPD provides a 100% sample of surgeries performed at nonfederal hospitals in California. Penile prosthetic surgeries were captured using ICD-9 codes in patients ≥50 years old. In both data sets, the primary end point was the total number of prosthetic surgeries performed and the proportion of inflatable vs. semi-rigid prosthesis, which was calculated annually. Binary logistic regression analysis was used to examine patient factors associated with the selection of inflatable vs. semi-rigid penile prosthesis. Using both NIS and OSPHD data sets, patient age, race, gender, insurance type (Medicare, Medicaid, private), Charlson comorbidity index score, comorbidities (hypertension, diabetes mellitus, obesity), history of Peyronie’s disease, history of spinal cord injury, history of prostate cancer, and hospital cost were abstracted. Comorbidities were documented using records from ICD-9 coding, and Appendix S1 summarizes the ICD-9 codes utilized. Chi-squared and Mann–Whitney U-tests were used to compare demographics, disease-specific variables, comorbidities and cost between inflatable and semi-rigid implants. Linear regression was used to compare rates of surgery over time, P value < 0.05 was considered significant. Results
Between 1998 and 2010, there was a significant decrease in the total number of hospital-based penile prosthetic surgeries performed in the United States (Figure 1). The number of cases decreased from 4,703 (1998) to 2,338 (2010). The proportion of inflatable penile prosthetic surgery significantly increased during this same time period (Table 1). In univariate analysis (Table 2), the proportion of Caucasians, men with Peyronie’s disease, or men with private insurance was higher among those receiving inflatable penile prosthesis. In contrast, the proportion of men with spinal cord injuries was significantly higher in semi-rigid prosthesis group. No differences were observed in rates of hypertension, diabetes mellitus, obesity, coronary artery disease, peripheral vascular disease or prostate cancer among patients receiving inflatable vs. semi-rigid prosthesis in the hospital setting. Between 1995 and 2010, there was also a significant decrease in the total number of penile implants performed in California hospitals (Figure 2). The proportion of inflatable penile implants significantly increased (Table 3). In uniJ Sex Med 2015;12:1092–1098
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Mirheydar et al.
Figure 1 Number of implants over time (NIS)
variate analysis (Table 4), proportions of Caucasian men, men without diabetes or hypertension, and men without obesity were all higher among men receiving inflatable implants. Similarly, men with higher Charlson comorbidity index were more likely to receive semi-rigid implant. No differences were observed in rates of hyperlipidemia, coronary artery disease, peripheral vascular disease, Peyronie’s disease, or prostate cancer among patients receiving inflatable vs. semi-rigid implants in a hospital in California. Nationally, the median charges associated with the inflatable penile implants were significantly higher than semi-rigid implants despite having the same median length of stay (Table 2). Similarly in California, the median hospital charges were significantly higher in men receiving inflatable vs. semi-rigid penile implants (Table 4). Multivariate analysis using OSHPD data (Table 5) showed that Caucasian race and ED not secondary to spinal cord injury were both independently associated with receipt of an inflatable penile implant. Multivariate analysis using NIS data (Table 6) showed that age range (70–79 compared with 50–59), private insurance, and Peyronie’s disease were all patient factors independently associated with receipt of an inflatable penile implant. J Sex Med 2015;12:1092–1098
Discussion
We observed that in both California and nationally, the total number of hospital-based penile prosthetic surgeries performed decreased between 1995 and 2010, while the proportion of inflatable prostheses increased between 2001 and 2010. These data are important because they highlight the modern trends of ED surgery performed in hospitals. The trends we observed are different from those reported previously [10]. Using industry
Table 1
Implants by year (NIS)
Year
Total implants
Semi-rigid penile prosthesis
IPP
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Total
4,703 4,692 5,396 5,486 4,802 4,261 3,878 4,102 4,189 3,599 3,239 3,282 2,338 53,967
571 578 728 567 521 501 498 292 369 293 202 194 173 5,488
4,133 4,114 4,668 4,919 4,280 3,760 3,380 3,810 3,819 3,305 3,038 3,088 2,165 48,479
1095
Trends in Surgical Treatment of Erectile Dysfunction Table 2
Semi-rigid vs. IPP (NIS) Semi-rigid (n = 5,488)
Age 50–59 60–69 70–79 80+ Race Caucasian AA Hispanic Asian Other Insurance Commercial Medicare Medicaid Other/limited DM HTN Hyperlipidemia Obesity PVD EDspinal Peyronies Prostate Ca Median LOS (IQR), days Median charges (IQR), $ Charlson 0–2 3+ Explant
IPP (n = 48,479)
P value
Number 1,678 2,324 1,280 206
% 30.6 42.3 23.3 3.8
Number 13,398 20,768 12,529 1,784
% 27.6 42.8 25.8 3.7
2,570 1,009 625 51 1,233
46.8 18.4 11.4 0.9 22.5
26,268 6,334 3,815 310 11,754
54.2 13.1 7.9 0.6 24.2
35.7 57 3 4.2 16.5 11.3 17.4 5.0 3.4 0.6 1.8 5.6
18,148 28,140 671 1,521 7,646 5,735 8,392 2229 1,536 118 1,803 1,913 1 (1–2) 29,720 (21,591–40,994)
37.4 58.0 1.4 3.1 15.8 11.8 17.3 4.6 3.2 0.2 3.7 3.9
95.1 4.9 2.6
46,332 2,148 592
95.6 4.4 1.2
0.127
<0.001
0.005 1,958 3,130 167 233 905 621 957 276 187 34 100 305 1 (1–2) 20,663 (13,183–30,311) 5,220 268 142
data, Wiser et al. reported a global increase of 8% annually in the total volume of penile implants performed between 2005 and 2011, with the largest increases observed in the United States [10]. Many factors likely contribute to the differences in the observations. First, we utilized an
0.541 0.637 0.930 0.591 0.732 0.030 0.001 0.210 0.593 <0.001 0.491 <0.001
administrative claims-based database independently maintained by the state of California (OSHPD) and HCUP that only capture penile prosthetic surgery performed in a hospital. All surgeries performed in outpatient ambulatory surgery centers were not captured. It is possible that
Figure 2 Number of implants over time (OSHPD)
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1096 Table 3
Mirheydar et al. Implants by year (OSHPD)
Year
Total implants
Semi-rigid penile prosthesis
IPP
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Total
760 699 627 416 457 454 533 535 491 420 380 390 354 354 329 318 7,517
173 145 139 76 87 100 115 96 85 64 47 41 35 35 43 37 1,318
587 554 488 340 370 354 418 439 406 356 333 349 319 319 286 281 6,199
industry-based data included both ambulatory and hospital-based penile prosthetic surgeries, and thus accounts for differences in our results. However, the proportion of surgeries performed
Table 4
in outpatient surgery centers remains unknown and warrants investigation in the future. The practice pattern of high volume vs. low volume implanters is clearly different but not well defined. It is possible that our observation excluded high volume implanters more likely to perform prosthetic surgeries in ambulatory surgery centers. Future studies to better understand the different practice patterns have the potential to identify appropriate patient selection for surgical planning (i.e., candidates for ambulatory setting). Furthermore, our results mirror those observed by Jhaveri et al. in North Carolina between 1988 and 1993 [11]. In this claims-based analysis of 151 North Carolina hospitals, the total number of penile prosthetic surgeries performed decreased significantly over the 6-year time period. The authors hypothesized that decreasing reimbursement over time and increased utilization of medical therapy may contribute to their observation, and also may explain the decreased number of penile implants performed in the United States [12]. In California, the median cost associated with inflatable penile prosthesis ($40,941) was signifi-
Semi-rigid vs. IPP (OSHPD) (n = 1,321)
Age 50–59 60–69 70–79 80+ Race Caucasian AA Hispanic Asian Other Insurance Commercial Medicare Medicaid Other/limited DM HTN Hyperlipidemia Obesity CAD PVD EDspinal Peyronies Prostate Ca Median LOS (IQR), days Median charges (IQR), $ Charlson 0–2 3+ Explant
J Sex Med 2015;12:1092–1098
IPP (n = 6,183)
P value 0.104
334 (25.3%) 547 (41.4%) 391 (29.6%) 49 (3.7%)
1,405 (22.7%) 2,580 (41.7%) 1,905 (30.8%) 293 (4.7%)
653 (70.4%) 105 (11.3%) 108 (11.7%) 21 (2.3%) 40 (4.3%)
3,556 (77.7%) 329 (7.2%) 363 (7.9%) 63 (1.4%) 266 (5.8%)
<0.001
<0.001 296 (37.6%) 447 (56.8%) 17 (2.2%) 27 (3.4%) 440 (33.3%) 608 (46.0%) 201 (15.2%) 90 (6.8%) 1 (0.1%) 44 (3.3%) 10 (0.76%) 22 (1.7%) 358 (27.1%) 1 (1–2) 19,248 (0–34,612) 1,247 (94.4%) 74 (5.6%) 19 (1.4%)
1,573 (37.3%) 2,524 (59.9%) 27 (0.6%) 89 (2.1%) 1,735 (28.1%) 2,640 (42.7%) 846 (13.7%) 290 (4.7%) 13 (0.2%) 160 (2.6%) 9 (0.2%) 144 (2.3%) 1,686 (27.3%) 1 (1–2) 40,941 (27,809–59,539) 5,916 (95.7%) 267 (4.3%) 60 (1.0%)
<0.001 0.027 0.144 0.001 0.304 0.132 <0.001 0.137 0.901 0.127 <0.001 0.042
0.130
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Trends in Surgical Treatment of Erectile Dysfunction Table 5
Odds of IPP implantation (OSHPD)
Caucasian ED from Spinal
OR
95% CI
P value
1.383 0.195
1.227 to 1.558 0.079 to 0.482
<0.001 <0.001
cantly more than the cost of semi-rigid implant ($19,248), a trend mirrored in the nationwide analysis ($29,720 vs. $20,663). This cost analysis was consistent with that performed by Buch et al. demonstrating the increased cost associated with inflatable compared with malleable penile implants [13]. Interestingly, in California, men with spinal cord injuries were significantly more likely to receive a semi-rigid or malleable penile implant. This finding reflects the known utility of malleable penile implants in managing both impotence and the urinary incontinence commonly observed in spinal cord injury patients [14]. Specifically, the semi-rigid implant in these patients facilitates urinary drainage with the use of external condom catheters in men with penile retraction, and thus not only provides improved continence but also treats impotence. Zermann et al. reported excellent resolution of urinary drainage problems as well as treatment of impotence in patients with spinal cord injuries with long-term follow-up [15]. However, it has also been shown that spinal cord injury patients might be better served with inflatable prosthesis due to concern for erosion [15]. Peyronie’s disease is known to be associated with concomitant ED [16]. Patients with Peyronie’s disease were over two times more likely to receive an inflatable penile prosthesis in the United States. A recent study by Chung et al. demonstrated that penile prosthetic surgery can be safely performed concurrently with curvature correction procedures and is associated with high patient satisfaction rates [17]. This finding reflects the previous report that inflatable devices can lead to higher functional satisfaction and lower rates of persistent penile curvature deformity compared with semi-rigid devices [18,19]. In addition, Caucasian race was independently associated with receipt of inflatable penile prosthesis, highlighting racial disparities in the surgical management of ED. Racial variation in the selection of penile prosthetic surgery was also described recently using a California administrative data set by Grewal et al. in which the authors demonstrated that African-American men were more likely to receive a semi-rigid implant [20]. Lower socioeco-
nomic status may account for selection of less expensive, and thus, semi-rigid implant; however, these findings highlight disparities in care warranting further investigation. In the United States, older men (ages 70 to 79) were significantly more likely to receive an inflatable penile prosthesis than younger men (ages 50 to 59). This was a surprising finding because one would anticipate that elderly men may have more difficulty handling the scrotal pump associated with inflatable prostheses, and thus prefer malleable semi-rigid implants because of their ease of use. Our finding that men aged 70–79 were more likely to receive an inflatable prosthesis compared with younger men was unexpected and warrants further investigation.
Limitations Limitations of the NIS are inherent to this data set—it relies on accurate physician coding and provides only a 20% estimate of all surgeries performed annually in the United States. There is also a trend toward penile prosthesis surgery in an outpatient setting; however, there are currently no data summarizing the distribution of penile prosthetic surgery performed in hospitals vs. in ambulatory surgery centers. Limitations of the OSHPD are that it does not include same-day surgery center data and also relies on accurate physician coding. Notwithstanding the above limitations, this study is important in that it quantitatively demonstrates a decrease in penile prosthesis surgery over the last 10–15 years in both California and nationally among patients undergoing surgery in a hospital, including patients who are admitted for 23-hour stays or discharged from the hospital after undergoing surgery. Table 6 Logistic regression with odds of IPP implantation (NIS)
Age (50–59 = ref) 60–69 70–79 80–89 Insurance (commercial = ref) Medicare Medicaid Other/limited Caucasian Charlson comorbidity index (CCI) ≥ 3 (CCI 0–2 = ref) Spinal cord injury Peyronies Prostate cancer
OR
95%CI
P value
1.159 1.278 1.126
0.993 1.074 0.780
1.354 1.522 1.627
0.062 0.006 0.525
0.881 0.461 0.688 1.303 1.033
0.753 0.290 0.410 1.080 0.746
1.040 0.730 1.140 1.570 1.430
0.137 0.001 0.149 0.005 0.846
0.462 2.038 0.715
0.188 1.308 0.392
1.134 3.176 1.304
0.092 0.002 0.274
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1098 Conclusion
This is the largest comprehensive analysis of modern trends in hospital-based penile prosthetic surgery. We observed an overall decrease in penile prosthetic surgery and an increase in the proportion of inflatable prostheses utilization. Future studies are needed to better understand the observed hospital-based trends and racial disparities in penile prosthetic surgery, and more importantly to quantify the distribution of penile prosthetic surgery performed in ambulatory surgery centers vs. hospitals. The California population database appeared to correlate with national trends and might be utilized in future studies. Corresponding Author: Tung-Chin Hsieh, MD, Department of Urology, UC San Diego Health System, 200 W Arbor Drive #8897, San Diego, CA 92103-8897, USA. Tel: (619) 543-2009; Fax: (619) 543-6573; E-mail: [email protected] Conflict of Interest: Tung-Chin Hsieh is a consultant for American Medical System. Statement of Authorship
Category 1 (a) Conception and Design Hossein S. Mirheydar; J. Kellogg Parsons; TungChin Hsieh (b) Acquisition of Data Kerrin L. Palazzi; David Chang (c) Analysis and Interpretation of Data Kerrin L. Palazzi; David Chang; Tung-Chin Hsieh
Category 2 (a) Drafting the Article Hossein S. Mirheydar; Kerrin L. Palazzi (b) Revising It for Intellectual Content Tung-Chin Hsieh; David Chang; J. Kellogg Parsons
Category 3 (a) Final Approval of the Completed Article Tung-Chin Hsieh References 1 Wessells H, Joyce GF, Wise M, Wilt TJ. Erectile dysfunction. J Urol 2007;177:1675–81. 2 Bernal RM, Henry GD. Contemporary patient satisfaction rates for three-piece inflatable penile prostheses. Adv Urol 2012;2012:1–5. 3 Brinkman MJ, Henry GD, Wilson SK, Delk JR II, Denny GA, Young M, Cleves MA. A survey of patients with inflatable penile prostheses for satisfaction. J Urol 2005;174:253–7.
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Supporting Information Additional Supporting Information may be found in the online version of this article at the publisher’s website: Appendix S1 Summary of ICD-9 codes used.
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