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Long-Term Follow-Up After Penile Prosthesis Implantation—Survival and Quality of Life Outcomes
ORIGINAL RESEARCH & REVIEWS
Long-Term Follow-Up After Penile Prosthesis Implantation—Survival and Quality of Life Outcomes Francesco Chierigo, MD,1,† Paolo Capogrosso, MD,1,† Federico Dehò, MD,1 Edoardo Pozzi, MD,1,2 Nicolò Schifano, MD,1 Federico Belladelli, MD,1,2 Francesco Montorsi, MD,1,2 and Andrea Salonia, MD, PhD1,2
ABSTRACT
Introduction: Hydraulic penile prostheses have shown an overall good mechanical reliability up to 10 years after surgery; however, few data have been published on very long-term follow-up. Aim: We looked at long-term (15 years) complications, including functional and quality of life (QoL) outcomes, after 3-piece inflatable penile prosthesis (IPP) implantation in patients with erectile dysfunction (ED). Methods: Data regarding 149 patients submitting to IPP placement before 2001 were analyzed. All patients were implanted with AMS CX and Ultrex Plus 3-piece prostheses. Main Outcome Measure: Patients were reassessed to evaluate rates of complications and functional outcomes. The validated questionnaire Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) was used to assess patient QoL. Kaplan-Meier analysis estimated the probability of prosthesis survival (defined as working device/ not-explanted). Results: Median follow-up of 51 patients was 206 months (interquartile range [IQR], 145e257). The etiology of ED was vasculogenic (n ¼ 20; 39%), Peyronie’s disease (n ¼ 15; 29%), pelvic surgery (n ¼ 4; 7.8%), organic other than vasculogenic (n ¼ 3; 5.9%), or other (n ¼ 9; 18%). Throughout the follow-up, 24 patients (49%) experienced complications: mechanical failure (n ¼ 19; 79%), pain (n ¼ 3; 12%), orgasmic dysfunctions (n ¼ 1; 4.5%), or device infection (n ¼ 1; 4.5%). The estimated IPP survival was 53% (95% CI, 36e67) at 20-year follow-up. Baseline characteristics (age, Charlson comorbidity index, body mass index, and erectile dysfunction etiology) were not significantly associated with the risk of IPP failure over time by Cox regression analysis. At 20-year follow-up, 41% (95% CI, 19e49) of the patients were still using the device. Among them, QoLSPP median domain scores were high: functional 22/25 (IQR, 20e23), relational 17/20 (IQR, 15e18), personal 14/ 15 (IQR, 12e15), and social 14/15 (IQR, 11e15). Clinical Implications: The longevity of the device and long-term satisfaction rates should be comprehensively discussed during patient consultation for IPP surgery. Strengths & Limitations: To our knowledge, this is the first study reporting long-term QoL outcomes using a dedicated questionnaire for penile prostheses. The low response rate for the telephone interviews, the retrospective design of the study, and the relatively small number of patients are the main limitations. Conclusion: Long-term follow-up data after IPP placement showed that almost half of the devices still worked properly 20 years after the original penile implant, as 60% of patients were still using the device with high satisfaction and adequate QoL outcomes. Both patients and physicians should be aware of the expected life and outcomes of IPP implants. Chierigo F, Capogrosso P, Dehò, et al. Long-Term Follow-Up After Penile Prosthesis Implantation—Survival and Quality of Life Outcomes. J Sex Med 2019;XX:XXXeXXX. Copyright 2019, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.
Key Words: Erectile Dysfunction; Penile Prosthesis; Satisfaction; Long-Term Follow-Up; QoLSPP
Received May 9, 2019. Accepted August 4, 2019. 1
Division of Experimental Oncology/Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy;
2
Università Vita-Salute San Raffaele, Milan, Italy
†
These authors contributed equally.
Copyright ª 2019, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved. https://doi.org/10.1016/j.jsxm.2019.08.001
J Sex Med 2019;-:1e7
INTRODUCTION Implantation of penile prostheses is a well-established third-line treatment option for the management of erectile dysfunction (ED) and Peyronie’s disease.1,2 Improvements in surgical techniques, materials, and product design over the past 4 decades have continued to reduce overall morbidity while increasing patient satisfaction.3 Today, the penile inflatable 1
2
prosthesis (IPP) is commonly used and considered to be the gold standard for ED patients who failed, rejected, or had contraindications to less invasive therapies.4 Indeed, the IPP most accurately replicates penile rigidity and flaccidity, has a low infection rate, and promotes the highest patient satisfaction among available devices.3,5,6 In this context, previous studies have found that up to 90% of patients reported high sexual satisfaction after IPP placement.6,7 These favorable outcomes have been associated with the good efficacy and reliability of available devices, as well as improved surgical techniques, which provide a low risk of complications and excellent functional results.8e10 Although several studies have reported outcomes and patient satisfaction with IPP placement, few long-term data (over 15 years) are available.3,11 For this reason, a critical analysis of IPP outcomes at long-term follow-up could be clinically relevant for both patients and physicians. Particularly, the longevity of a prosthesis device is an important issue that deserves to be thoroughly discussed during patient consultations before surgery, because IPP placement is a serious and not easily reversible procedure. Also, because it is a hydraulic system, the IPP may eventually require revision surgery over its life time. Of further clinical relevance, patients could have concerns about long-term satisfaction; in fact, patient satisfaction is a complex and multifactorial issue that is difficult to define and is growing in importance in terms of quality of life (QoL) outcomes.10,12 Most of the previous studies assessing IPP outcomes have used non-validated tools to assess sexual satisfaction and patient quality of life.8,13e15 In other surveys, treatment satisfaction was mostly assessed using tools such as the International Index of Erectile Function (IIEF) or the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), both of which had been originally designed and validated to deal with treatment modalities other than the IPP.16e20 As such, their use may result in inaccurate assessments of functional outcomes and patient satisfaction after IPP placement.8 Indeed, specific issues related to implant function and the associated impact on the QoL of patients and their partners are not investigated by questionnaires commonly used to assess ED outcomes after either oral or topical treatments. To overcome these limitations, Caraceni and Utizi21 developed the Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) questionnaire, which has been validated in a cohort of patients treated with a IPP for ED. The instrument was developed with the specific goal of providing a reliable tool to simultaneously evaluate both the perceived penile prosthesis function and postoperative QoL. To date, 2 studies have reported findings dealing with IPP outcomes assessed with this tool.22,23 The aim of this study was to use the QoLSPP to investigate long-term complications and functional and QoL outcomes following 3-piece IPP placement in patients more than 17 years ago at a single center.
Chierigo et al
METHODS We conducted a retrospective single-center analysis of 149 patients who had been implanted with AMS CX or Ultrex Plus 3-piece prostheses (American Medical Systems; Minnetonka, MN) from October 1991 to October 2001. Data collection followed the principles outlined in the Declaration of Helsinki; all patients signed an informed consent agreeing to share their own anonymous information for future studies. The study was approved by the local ethical committee (IRCCS Ospedale San Raffaele: protocol N. 2014-outpatient clinic). The etiology of ED, defined as vasculogenic, organic (other than vasculogenic, such as diabetic), Peyronie’s disease, postpelvic surgery, or other (eg, neurogenic, psychogenic, posttraumatic), and the surgical approach (penoscrotal vs suprapubic approach) were collected from the patient information forms. Moreover, patients were assessed with a thorough medical history, including data on health-significant comorbidities as scored with the Charlson comorbidity index (CCI).24 Body mass index (BMI) was calculated for every patient using their reported weight and height. Information regarding postoperative complications, prosthesis replacement or removal, and long-term use of the implants was obtained by a telephone interview in October 2018. Complications were coded as follows: (i) mechanical failure, including pump malfunction or aneurysm (not tolerated by the patient and thus requiring replacement); (ii) fluid loss (leakage at any site hampering inflation of the prosthesis); (iii) pain (scrotal or penile, enough to hamper the patient’s quality of life); (iv) orgasmic dysfunction (hyporgasmia or anorgasmia); or (v) device infection. For each patient, QoL was assessed using the QoLSPP at the follow-up assessment.21 This instrument investigates 4 domains: prosthesis function (functional), relationship with partner (relational), relation to the outside world (social), and self-image (personal). Each domain is composed of a different number of items (from 3 to 5), and responses are based on a 6-point (0e5) Likert scale, ranging from “never” (0) to “always” (5), where higher values represent more positive responses. Of the original 149 patients, complete follow-up data were retrieved for 51 of them (34.2%); 84 patients (56.4%) were lost to follow-up, and 14 patients (9.4%) had died at the time of follow-up assessment.
Statistical Analysis The aim of the study was to evaluate IPP survival, long-term complications, and QoLSPP scores. Differences in terms of QoLSPP scores according to ED etiology and surgical approach were tested, and the likelihood of regularly using the device at long-term follow-up was also investigated. At follow-up assessments, prosthesis survival was defined as a prosthesis that was working or not explanted. The timing and type of postoperative complications, mechanical failures, or prosthesis replacement or removal were also recorded. The length of actual use of the device was calculated from the date of either the first implant or J Sex Med 2019;-:1e7
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Long-Term Follow-Up After Penile Prosthesis Implantation
Table 1. Patient baseline characteristics (N ¼ 51) Characteristic
Value
Age (y), median (IQR) Body mass index (kg/m2), median (IQR) Follow-up (mo), median (IQR) Charlson comorbidity index, n (%) 0 1 Etiology of erectile dysfunction, n (%) Vasculogenic Peyronie’s disease Pelvic surgery Organic Other Surgical approach, n (%) Penoscrotal Sovrapubic
51 (47e57) 25.7 (23.0e29.1) 206 (145e257) 18 (35) 33 (65) 20 15 4 3 9
(39) (29) (7.8) (5.9) (18)
42 (83) 9 (17)
IQR ¼ interquartile range.
device replacement until the date the patient stopped using the device. Kaplan-Meier analysis was used to estimate the probability of prosthesis survival and the rate of patients regularly using the device over time. Cox regression analysis was used to assess whether baseline characteristics (age, CCI, BMI, ED etiology, year of surgery) were associated with IPP failure and rate of actual use. Given that follow-up data were not available for all cases and that patients lost to follow-up could have been treated elsewhere for complications or been less satisfied with the treatment they had received, we performed a sensitivity analysis to check for potential differences in terms of baseline characteristics between patients with and without follow-up data, in order to reduce potential selection biases. Statistical tests were performed using STATA 14 (StataCorp; College Station, TX). All tests were 2 sided, with a significance level set at .05.
RESULTS Table 1 details the characteristics of the 51 patients for whom we had complete follow-up data. The median age at surgery was 51 years (interquartile range [IQR], 47e57). Most of the patients underwent surgery for vasculogenic ED (39%) and Peyronie’s disease (29%). A penoscrotal approach was applied in the majority of cases (83%), and median follow-up time was 206 months (IQR, 145e257) (Table 1). Table 2 reports long-term surgical outcomes. Overall, 34 patients (67%) had the implant removed or replaced or experienced mechanical complications. Of those, 16 patients (32%) received a penile prosthesis replacement. Mechanical failure emerged as the main reason for IPP replacement (69%), followed by fluid loss (12%), cylinder displacement (12%), and device infection (6.2%) (Table 2). Implant removal was noted for 11 patients (22%). J Sex Med 2019;-:1e7
Table 2. Postoperative functional and quality-of-life outcomes at follow-up assessment Outcome Failure (mechanical failure, removal, or replacement), n (%) No Yes Prostheses removed, n (%) No Yes Prostheses replaced, n (%) No Yes Reason for prosthesis replacement, n (%) Mechanical failure Fluid loss Cylinder displacement Device infection Estimated probability of device survival over time* 60 mo 120 mo 180 mo 240 mo Type of complication (N ¼ 24), n (%) Mechanical failure Pain Orgasmic dysfunction Device infection Estimated probability of regularly using the device over time* 60 mo 120 mo 180 mo 240 mo Reason for stopping use of the device over time (N ¼ 31), n (%) Partner issues Advanced age Complications QoLSPP scores in patients still using the device at follow-up, median (IQR) Functional Relational Personal Social Total
17 (33) 34 (67) 40 (78) 11 (22) 35 (69) 16 (32) 11 2 2 1
(69) (12) (12) (6.2)
96% 86% 69% 53%
(95% (95% (95% (95%
19 3 1 1
(79) (12) (4.2) (4.2)
95% 90% 75% 62%
(95% (95% (95% (95%
CI, CI, CI, CI,
83e99) 71e93) 52e80) 36e67)
CI, CI, CI, CI,
83e99) 76e96) 58e86) 44e76)
4 (13) 3 (9) 24 (78)
22/25 17/20 19/20 14/15 70/80
(20e23) (15e18) (16e19) (11e15) (69e72)
IQR ¼ interquartile range; QoLSPP ¼ Quality of Life and Sexuality with Penile Prosthesis survey. *Estimated according to Kaplan-Meier analysis.
Throughout the follow-up, the complications reported for 24 cases included mechanical failure in 19 patients (79%), pain in 3 patients (12%), orgasmic disturbances in 1 patient (4.2%), and
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Chierigo et al
Figure 1. Kaplan-Meier analysis showing estimates of (a) prosthesis survival and (b) use over time, where time is computed from the first or replaced implant to the last date of regular use of the device. Figure 1 is available in color online at www.jsm.jsexmed.org.
device infection in 1 patient (4.2%). The Kaplan-Meier (Figure 1a) estimate of prosthesis survival was 96% (95% CI, 83e99) at 5 years, 86% (95% CI, 71e93) at 10 years, and 53% (95% CI, 36e67) at 20 years (Table 2). The estimated probability of regular use of the device (either the original or a replaced one) was 62% (95% CI, 44e76) at the 20-year assessment (Table 2; Figure 1b). Patients still using the device at follow-up assessment and who had completed the QoLSPP had high median scores in the functional (22/25), relational (17/20), personal (19/20), and social (14/15) domains of the instrument (Table 2). No differences were observed in terms of QoLSPP scores according to ED etiology and surgical approach (Supplementary Table 1). The reasons for stopping use of the device included postsurgical complications (78%), advanced age (9%), and partner issues (13%). Based on Cox regression analysis, baseline characteristics (age, CCI, BMI, ED etiology) were not significantly associated with the probability of IPP failure or stopping use of the device over time (Table 3). Conversely, patients treated in more recent years were more likely to quit using the device (hazard ratio, 1.22; 95% CI, 1.08e1.39; P ¼ .002). Sensitivity analysis indicated that patients lost to follow-up more frequently had an organic (other than vasculogenic) ED and were significantly older compared to patients with complete long-term follow-up data (Supplementary Table 2). Conversely there was no difference in terms of year of IPP surgery, type of surgical approach, or patient BMI.
DISCUSSION The ideal prosthesis would provide, as closely as possible, normal penile flaccidity and erection, without compromising ejaculatory function, and it should offer long-term mechanical and functional survival. Here, we report the long-term outcomes of AMS CX and Ultrex Plus prostheses as assessed with a questionnaire especially developed for outcome research in an IPP setting. Overall, we observed a good prosthesis survival rate, as almost 1 out of 2 devices were still in place and properly
working 20 years after surgery. In addition to device durability, we also looked at the active use of an IPP over time; interestingly enough, we found that more than half of the patients were likely to regularly use the device even 20 years after it was implanted. These results confirm previous observations.3,25,26 For example, Wilson et al3 reported that the mechanical survival rates of the AMS 700 CX IPP at 5, 10, and 15 years were 85%, 68%, and 57%, respectively; the overall survival rates were 77%, 59%, and 48%, respectively. Similarly, Dhar et al25 reported that the 10-year mechanical and overall survival rates of the AMS 700 CX and CXM were 81.3% and 74.9%, respectively. To evaluate the clinical factors related to the implant survival rate, we analyzed patient age, comorbidities (as assessed with the CCI), BMI, and ED etiology. Based on Cox regression analysis, these factors were not associated with device failure. In line with this finding, Ji et al11 failed to find any significant association between age, obesity, hypertension, diabetes mellitus, or cause of ED with device survival. Implantation of a penile prosthesis is known to offer excellent long-term patient satisfaction as compared with other treatment modalities, including oral pharmacotherapy and penile injection therapy.27,28 In a European multi-institutional study with 200 patients, Montorsi et al15 reported that, at a mean follow-up of 59 months (range 6e130) after AMS 3-piece IPP placement, the overall patient and partner satisfaction rates were 92% and 96%, respectively. Natali et al17 used the EDITS questionnaire to report satisfaction rates for the AMS 700 CX; at a mean postoperative follow-up of 60 months, the satisfaction rates for patients and their partners were 97% and 91%, respectively. Vitarelli et al29 used the IIEF and EDITS to assess patient satisfaction at 27.6-month mean follow-up after 2-piece IPP placement; their findings suggested median postoperative IIEF and EDITS scores of 21.46 and 73.11, respectively, revealing a high level of satisfaction. More recently, Habous et al10 evaluated the satisfaction rate in a large cohort of 902 patients after IPP placement by asking a J Sex Med 2019;-:1e7
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Long-Term Follow-Up After Penile Prosthesis Implantation
Table 3. Cox regression analysis predicting inflatable penile prosthesis failure and stopping use of it Failure
Age Charlson comorbidity index, 0 vs 1 Body mass index Year of surgery Erectile dysfunction etiology Organic/vascular vs Peyronie’s disease Organic/vascular vs pelvic surgery
Stopped using
Hazard ratio
95% CI
P value
Hazard ratio
95% CI
P value
1.00 0.51 1.02 1.18
0.94e1.05 0.21e1.24 0.90e1.15 0.94e1.48
.9 .14 .7 .14
1.01 0.55 1.04 1.22
0.94e1.09 0.15e1.94 0.88e1.23 1.08e1.39
.7 .3 .6 .002
1.15 0.58
0.42e3.14 0.07e5.11
.8 .6
1.97 0.54
0.69e5.66 0.06e4.43
.1 .5
single question with a 5-point Likert scale (5 being the most satisfied) scoring system. Of relevance, 6 months after surgery, 97.5% of men were satisfied with their IPP; conversely, patients with any complication had a reduced rate of satisfaction (P < .001), and that reduction was even more pronounced with a major complication (P < .001). Overall, it is of major importance to emphasize that the use of either a non-validated questionnaire or a tool developed for a non-PPI population could lead to improper estimation of patient satisfaction. Indeed, with both strategies, it is possible to miss considering some relevant aspects of QoL, such as the patient’s relationship with his partner, as well as functional aspects, such as device operability and simplicity of use, all aspects that are relevant to IPP patients.8,30 To attempt to overcome these significant biases, we applied a tool specifically developed and validated to assess patient QoL and perceived prosthesis function,21 in order to provide more reliable data, especially in terms of patient satisfaction after PPI placement. Another strength of this study is that it involved the longest follow-up ever considered in this type of setting. The QoLSPP scores indicated high satisfaction in terms of prosthesis function, the couple’s sexual life, the patient’s relationship with the outside world, and the patient’s self-esteem. Moreover, our data show that about 60% of patients are likely to keep using the device after 20 years from surgery, further suggesting that patients are still satisfied with their treatment even several years after surgery. Interestingly, we observed that patients implanted in more recent years were more likely to quit using the prosthesis. In our opinion, this could reflect differences in terms of patient selection over time. Moreover, patients who have been reimplanted recently could be less satisfied with the device and thus more likely to stop using it. Our study is not without some limitations. The response rate for the telephone interview was low, thus potentially creating a selection bias; however, to overcome this, we compared the baseline characteristics of patients with and without complete follow-up data, and we did not observe any difference in terms of surgical approach and year of surgery, both factors with potential impact on postoperative outcomes. Patients lost to follow-up were significantly older and therefore probably less likely to J Sex Med 2019;-:1e7
keep using the device at long-term assessment, thus suggesting that our reported rate of patients regularly using the device at follow-up could be overestimated. Also, this study had a retrospective design and a relatively small number of patients. However, the use of a dedicated tool specifically developed and validated to assess patient QoL in men who have undergone IPP placement by a single experienced surgeon21 in a single center could help overcome any bias associated with such small numbers. In this context, having patients recall complications and rate their satisfaction during a telephone interview might represent a major bias, as such interviews have relatively low accuracy compared to face-to-face interviews. Our data are representative of a single-center, single-surgeon historical series but may not be generalizable to the series already published. Only 4 patients (7.8%) submitted to IPP placement after pelvic surgery, which differs from other series published so far; however, current analyses have demonstrated that ED etiology per se is not predictive of prosthesis survival. More specifically, of the 4 patients who were implanted after pelvic surgery, 1 patient’s IPP was explanted after 5 months due to pain, 1 patient required prosthesis replacement for a mechanical failure after 39 months, and 2 patients were still using the implant and reported active use after more than 10 years of follow-up.
CONCLUSION These current findings represent the longest follow-up to date using a dedicated tool to evaluate long-term complications and patient satisfaction after 3-piece IPP implantation. At a median follow-up time of 17 years, 1 out of 2 devices were still working properly, and up to 60% of patients were still using their devices with high satisfaction and adequate QoL outcomes. Both patients and physicians should be aware of the long life and overall positive outcomes of IPP. Corresponding Author: Andrea Salonia, MD, PhD, University Vita-Salute San Raffaele, Division of Experimental Oncology/ Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy. Tel: þ39 02 26435506; Fax: þ39 02 26432969; E-mail: salonia. [email protected]
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Conflict of Interest: None. Funding: None.
STATEMENT OF AUTHORSHIP Category 1 (a) Conception and Design Francesco Chierigo; Paolo Capogrosso; Andrea Salonia (b) Acquisition of Data Francesco Chierigo; Federico Dehò (c) Analysis and Interpretation of Data Francesco Chierigo; Paolo Capogrosso; Federico Belladelli; Pozzi Edoardo; Schifano Nicolò Category 2 (a) Drafting the Article Francesco Chierigo; Paolo Capogrosso; Andrea Salonia (b) Revising It for Intellectual Content Francesco Chierigo; Paolo Capogrosso; Andrea Salonia Category 3 (a) Final Approval of the Completed Article Francesco Chierigo; Paolo Capogrosso; Federico Dehò; Edoardo Pozzi; Nicolò Schifano; Federico Belladelli; Francesco Montorsi; Andrea Salonia
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Long-Term Follow-Up After Penile Prosthesis Implantation 25. Dhar NB, Angermeier KW, Montague DK. Long-term mechanical reliability of AMS 700CXTM/CXM inflatable penile prosthesis. J Urol 2006;176:2599-2601. 26. Kim DS, Yang KM, Chung HJ, et al. AMS 700CX/CXM inflatable penile prosthesis has high mechanical reliability at long-term follow-up. J Sex Med 2010;7:2602-2607. 27. 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; 170:159-163. 28. Candela JV, Hellstrom WJ. Three-piece inflatable penile prosthesis implantation: a comparison of the penoscrotal and infrapubic surgical approaches. J La State Med Soc 1996; 148:296-301.
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29. Vitarelli A, Divenuto L, Fortunato F, et al. Long term patient satisfaction and quality of life with AMS700CX inflatable penile prosthesis. Arch Ital Urol Androl 2013;85:133-137. 30. Carvalheira A, Santana R, Pereira NM. Why are men satisfied or dissatisfied with penile implants? A mixed method study on satisfaction with penile prosthesis implantation. J Sex Med 2015;12:2474-2480.
SUPPLEMENTARY DATA Supplementary data related to this article can be found online at https://doi.org/10.1016/j.jsxm.2019.08.001.
Long-Term Follow-Up After Penile Prosthesis Implantation—Survival and Quality of Life Outcomes Francesco Chierigo, MD,1,† Paolo Capogrosso, MD,1,† Federico Dehò, MD,1 Edoardo Pozzi, MD,1,2 Nicolò Schifano, MD,1 Federico Belladelli, MD,1,2 Francesco Montorsi, MD,1,2 and Andrea Salonia, MD, PhD1,2
ABSTRACT
Introduction: Hydraulic penile prostheses have shown an overall good mechanical reliability up to 10 years after surgery; however, few data have been published on very long-term follow-up. Aim: We looked at long-term (15 years) complications, including functional and quality of life (QoL) outcomes, after 3-piece inflatable penile prosthesis (IPP) implantation in patients with erectile dysfunction (ED). Methods: Data regarding 149 patients submitting to IPP placement before 2001 were analyzed. All patients were implanted with AMS CX and Ultrex Plus 3-piece prostheses. Main Outcome Measure: Patients were reassessed to evaluate rates of complications and functional outcomes. The validated questionnaire Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) was used to assess patient QoL. Kaplan-Meier analysis estimated the probability of prosthesis survival (defined as working device/ not-explanted). Results: Median follow-up of 51 patients was 206 months (interquartile range [IQR], 145e257). The etiology of ED was vasculogenic (n ¼ 20; 39%), Peyronie’s disease (n ¼ 15; 29%), pelvic surgery (n ¼ 4; 7.8%), organic other than vasculogenic (n ¼ 3; 5.9%), or other (n ¼ 9; 18%). Throughout the follow-up, 24 patients (49%) experienced complications: mechanical failure (n ¼ 19; 79%), pain (n ¼ 3; 12%), orgasmic dysfunctions (n ¼ 1; 4.5%), or device infection (n ¼ 1; 4.5%). The estimated IPP survival was 53% (95% CI, 36e67) at 20-year follow-up. Baseline characteristics (age, Charlson comorbidity index, body mass index, and erectile dysfunction etiology) were not significantly associated with the risk of IPP failure over time by Cox regression analysis. At 20-year follow-up, 41% (95% CI, 19e49) of the patients were still using the device. Among them, QoLSPP median domain scores were high: functional 22/25 (IQR, 20e23), relational 17/20 (IQR, 15e18), personal 14/ 15 (IQR, 12e15), and social 14/15 (IQR, 11e15). Clinical Implications: The longevity of the device and long-term satisfaction rates should be comprehensively discussed during patient consultation for IPP surgery. Strengths & Limitations: To our knowledge, this is the first study reporting long-term QoL outcomes using a dedicated questionnaire for penile prostheses. The low response rate for the telephone interviews, the retrospective design of the study, and the relatively small number of patients are the main limitations. Conclusion: Long-term follow-up data after IPP placement showed that almost half of the devices still worked properly 20 years after the original penile implant, as 60% of patients were still using the device with high satisfaction and adequate QoL outcomes. Both patients and physicians should be aware of the expected life and outcomes of IPP implants. Chierigo F, Capogrosso P, Dehò, et al. Long-Term Follow-Up After Penile Prosthesis Implantation—Survival and Quality of Life Outcomes. J Sex Med 2019;XX:XXXeXXX. Copyright 2019, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.
Key Words: Erectile Dysfunction; Penile Prosthesis; Satisfaction; Long-Term Follow-Up; QoLSPP
Received May 9, 2019. Accepted August 4, 2019. 1
Division of Experimental Oncology/Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy;
2
Università Vita-Salute San Raffaele, Milan, Italy
†
These authors contributed equally.
Copyright ª 2019, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved. https://doi.org/10.1016/j.jsxm.2019.08.001
J Sex Med 2019;-:1e7
INTRODUCTION Implantation of penile prostheses is a well-established third-line treatment option for the management of erectile dysfunction (ED) and Peyronie’s disease.1,2 Improvements in surgical techniques, materials, and product design over the past 4 decades have continued to reduce overall morbidity while increasing patient satisfaction.3 Today, the penile inflatable 1
2
prosthesis (IPP) is commonly used and considered to be the gold standard for ED patients who failed, rejected, or had contraindications to less invasive therapies.4 Indeed, the IPP most accurately replicates penile rigidity and flaccidity, has a low infection rate, and promotes the highest patient satisfaction among available devices.3,5,6 In this context, previous studies have found that up to 90% of patients reported high sexual satisfaction after IPP placement.6,7 These favorable outcomes have been associated with the good efficacy and reliability of available devices, as well as improved surgical techniques, which provide a low risk of complications and excellent functional results.8e10 Although several studies have reported outcomes and patient satisfaction with IPP placement, few long-term data (over 15 years) are available.3,11 For this reason, a critical analysis of IPP outcomes at long-term follow-up could be clinically relevant for both patients and physicians. Particularly, the longevity of a prosthesis device is an important issue that deserves to be thoroughly discussed during patient consultations before surgery, because IPP placement is a serious and not easily reversible procedure. Also, because it is a hydraulic system, the IPP may eventually require revision surgery over its life time. Of further clinical relevance, patients could have concerns about long-term satisfaction; in fact, patient satisfaction is a complex and multifactorial issue that is difficult to define and is growing in importance in terms of quality of life (QoL) outcomes.10,12 Most of the previous studies assessing IPP outcomes have used non-validated tools to assess sexual satisfaction and patient quality of life.8,13e15 In other surveys, treatment satisfaction was mostly assessed using tools such as the International Index of Erectile Function (IIEF) or the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), both of which had been originally designed and validated to deal with treatment modalities other than the IPP.16e20 As such, their use may result in inaccurate assessments of functional outcomes and patient satisfaction after IPP placement.8 Indeed, specific issues related to implant function and the associated impact on the QoL of patients and their partners are not investigated by questionnaires commonly used to assess ED outcomes after either oral or topical treatments. To overcome these limitations, Caraceni and Utizi21 developed the Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) questionnaire, which has been validated in a cohort of patients treated with a IPP for ED. The instrument was developed with the specific goal of providing a reliable tool to simultaneously evaluate both the perceived penile prosthesis function and postoperative QoL. To date, 2 studies have reported findings dealing with IPP outcomes assessed with this tool.22,23 The aim of this study was to use the QoLSPP to investigate long-term complications and functional and QoL outcomes following 3-piece IPP placement in patients more than 17 years ago at a single center.
Chierigo et al
METHODS We conducted a retrospective single-center analysis of 149 patients who had been implanted with AMS CX or Ultrex Plus 3-piece prostheses (American Medical Systems; Minnetonka, MN) from October 1991 to October 2001. Data collection followed the principles outlined in the Declaration of Helsinki; all patients signed an informed consent agreeing to share their own anonymous information for future studies. The study was approved by the local ethical committee (IRCCS Ospedale San Raffaele: protocol N. 2014-outpatient clinic). The etiology of ED, defined as vasculogenic, organic (other than vasculogenic, such as diabetic), Peyronie’s disease, postpelvic surgery, or other (eg, neurogenic, psychogenic, posttraumatic), and the surgical approach (penoscrotal vs suprapubic approach) were collected from the patient information forms. Moreover, patients were assessed with a thorough medical history, including data on health-significant comorbidities as scored with the Charlson comorbidity index (CCI).24 Body mass index (BMI) was calculated for every patient using their reported weight and height. Information regarding postoperative complications, prosthesis replacement or removal, and long-term use of the implants was obtained by a telephone interview in October 2018. Complications were coded as follows: (i) mechanical failure, including pump malfunction or aneurysm (not tolerated by the patient and thus requiring replacement); (ii) fluid loss (leakage at any site hampering inflation of the prosthesis); (iii) pain (scrotal or penile, enough to hamper the patient’s quality of life); (iv) orgasmic dysfunction (hyporgasmia or anorgasmia); or (v) device infection. For each patient, QoL was assessed using the QoLSPP at the follow-up assessment.21 This instrument investigates 4 domains: prosthesis function (functional), relationship with partner (relational), relation to the outside world (social), and self-image (personal). Each domain is composed of a different number of items (from 3 to 5), and responses are based on a 6-point (0e5) Likert scale, ranging from “never” (0) to “always” (5), where higher values represent more positive responses. Of the original 149 patients, complete follow-up data were retrieved for 51 of them (34.2%); 84 patients (56.4%) were lost to follow-up, and 14 patients (9.4%) had died at the time of follow-up assessment.
Statistical Analysis The aim of the study was to evaluate IPP survival, long-term complications, and QoLSPP scores. Differences in terms of QoLSPP scores according to ED etiology and surgical approach were tested, and the likelihood of regularly using the device at long-term follow-up was also investigated. At follow-up assessments, prosthesis survival was defined as a prosthesis that was working or not explanted. The timing and type of postoperative complications, mechanical failures, or prosthesis replacement or removal were also recorded. The length of actual use of the device was calculated from the date of either the first implant or J Sex Med 2019;-:1e7
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Long-Term Follow-Up After Penile Prosthesis Implantation
Table 1. Patient baseline characteristics (N ¼ 51) Characteristic
Value
Age (y), median (IQR) Body mass index (kg/m2), median (IQR) Follow-up (mo), median (IQR) Charlson comorbidity index, n (%) 0 1 Etiology of erectile dysfunction, n (%) Vasculogenic Peyronie’s disease Pelvic surgery Organic Other Surgical approach, n (%) Penoscrotal Sovrapubic
51 (47e57) 25.7 (23.0e29.1) 206 (145e257) 18 (35) 33 (65) 20 15 4 3 9
(39) (29) (7.8) (5.9) (18)
42 (83) 9 (17)
IQR ¼ interquartile range.
device replacement until the date the patient stopped using the device. Kaplan-Meier analysis was used to estimate the probability of prosthesis survival and the rate of patients regularly using the device over time. Cox regression analysis was used to assess whether baseline characteristics (age, CCI, BMI, ED etiology, year of surgery) were associated with IPP failure and rate of actual use. Given that follow-up data were not available for all cases and that patients lost to follow-up could have been treated elsewhere for complications or been less satisfied with the treatment they had received, we performed a sensitivity analysis to check for potential differences in terms of baseline characteristics between patients with and without follow-up data, in order to reduce potential selection biases. Statistical tests were performed using STATA 14 (StataCorp; College Station, TX). All tests were 2 sided, with a significance level set at .05.
RESULTS Table 1 details the characteristics of the 51 patients for whom we had complete follow-up data. The median age at surgery was 51 years (interquartile range [IQR], 47e57). Most of the patients underwent surgery for vasculogenic ED (39%) and Peyronie’s disease (29%). A penoscrotal approach was applied in the majority of cases (83%), and median follow-up time was 206 months (IQR, 145e257) (Table 1). Table 2 reports long-term surgical outcomes. Overall, 34 patients (67%) had the implant removed or replaced or experienced mechanical complications. Of those, 16 patients (32%) received a penile prosthesis replacement. Mechanical failure emerged as the main reason for IPP replacement (69%), followed by fluid loss (12%), cylinder displacement (12%), and device infection (6.2%) (Table 2). Implant removal was noted for 11 patients (22%). J Sex Med 2019;-:1e7
Table 2. Postoperative functional and quality-of-life outcomes at follow-up assessment Outcome Failure (mechanical failure, removal, or replacement), n (%) No Yes Prostheses removed, n (%) No Yes Prostheses replaced, n (%) No Yes Reason for prosthesis replacement, n (%) Mechanical failure Fluid loss Cylinder displacement Device infection Estimated probability of device survival over time* 60 mo 120 mo 180 mo 240 mo Type of complication (N ¼ 24), n (%) Mechanical failure Pain Orgasmic dysfunction Device infection Estimated probability of regularly using the device over time* 60 mo 120 mo 180 mo 240 mo Reason for stopping use of the device over time (N ¼ 31), n (%) Partner issues Advanced age Complications QoLSPP scores in patients still using the device at follow-up, median (IQR) Functional Relational Personal Social Total
17 (33) 34 (67) 40 (78) 11 (22) 35 (69) 16 (32) 11 2 2 1
(69) (12) (12) (6.2)
96% 86% 69% 53%
(95% (95% (95% (95%
19 3 1 1
(79) (12) (4.2) (4.2)
95% 90% 75% 62%
(95% (95% (95% (95%
CI, CI, CI, CI,
83e99) 71e93) 52e80) 36e67)
CI, CI, CI, CI,
83e99) 76e96) 58e86) 44e76)
4 (13) 3 (9) 24 (78)
22/25 17/20 19/20 14/15 70/80
(20e23) (15e18) (16e19) (11e15) (69e72)
IQR ¼ interquartile range; QoLSPP ¼ Quality of Life and Sexuality with Penile Prosthesis survey. *Estimated according to Kaplan-Meier analysis.
Throughout the follow-up, the complications reported for 24 cases included mechanical failure in 19 patients (79%), pain in 3 patients (12%), orgasmic disturbances in 1 patient (4.2%), and
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Chierigo et al
Figure 1. Kaplan-Meier analysis showing estimates of (a) prosthesis survival and (b) use over time, where time is computed from the first or replaced implant to the last date of regular use of the device. Figure 1 is available in color online at www.jsm.jsexmed.org.
device infection in 1 patient (4.2%). The Kaplan-Meier (Figure 1a) estimate of prosthesis survival was 96% (95% CI, 83e99) at 5 years, 86% (95% CI, 71e93) at 10 years, and 53% (95% CI, 36e67) at 20 years (Table 2). The estimated probability of regular use of the device (either the original or a replaced one) was 62% (95% CI, 44e76) at the 20-year assessment (Table 2; Figure 1b). Patients still using the device at follow-up assessment and who had completed the QoLSPP had high median scores in the functional (22/25), relational (17/20), personal (19/20), and social (14/15) domains of the instrument (Table 2). No differences were observed in terms of QoLSPP scores according to ED etiology and surgical approach (Supplementary Table 1). The reasons for stopping use of the device included postsurgical complications (78%), advanced age (9%), and partner issues (13%). Based on Cox regression analysis, baseline characteristics (age, CCI, BMI, ED etiology) were not significantly associated with the probability of IPP failure or stopping use of the device over time (Table 3). Conversely, patients treated in more recent years were more likely to quit using the device (hazard ratio, 1.22; 95% CI, 1.08e1.39; P ¼ .002). Sensitivity analysis indicated that patients lost to follow-up more frequently had an organic (other than vasculogenic) ED and were significantly older compared to patients with complete long-term follow-up data (Supplementary Table 2). Conversely there was no difference in terms of year of IPP surgery, type of surgical approach, or patient BMI.
DISCUSSION The ideal prosthesis would provide, as closely as possible, normal penile flaccidity and erection, without compromising ejaculatory function, and it should offer long-term mechanical and functional survival. Here, we report the long-term outcomes of AMS CX and Ultrex Plus prostheses as assessed with a questionnaire especially developed for outcome research in an IPP setting. Overall, we observed a good prosthesis survival rate, as almost 1 out of 2 devices were still in place and properly
working 20 years after surgery. In addition to device durability, we also looked at the active use of an IPP over time; interestingly enough, we found that more than half of the patients were likely to regularly use the device even 20 years after it was implanted. These results confirm previous observations.3,25,26 For example, Wilson et al3 reported that the mechanical survival rates of the AMS 700 CX IPP at 5, 10, and 15 years were 85%, 68%, and 57%, respectively; the overall survival rates were 77%, 59%, and 48%, respectively. Similarly, Dhar et al25 reported that the 10-year mechanical and overall survival rates of the AMS 700 CX and CXM were 81.3% and 74.9%, respectively. To evaluate the clinical factors related to the implant survival rate, we analyzed patient age, comorbidities (as assessed with the CCI), BMI, and ED etiology. Based on Cox regression analysis, these factors were not associated with device failure. In line with this finding, Ji et al11 failed to find any significant association between age, obesity, hypertension, diabetes mellitus, or cause of ED with device survival. Implantation of a penile prosthesis is known to offer excellent long-term patient satisfaction as compared with other treatment modalities, including oral pharmacotherapy and penile injection therapy.27,28 In a European multi-institutional study with 200 patients, Montorsi et al15 reported that, at a mean follow-up of 59 months (range 6e130) after AMS 3-piece IPP placement, the overall patient and partner satisfaction rates were 92% and 96%, respectively. Natali et al17 used the EDITS questionnaire to report satisfaction rates for the AMS 700 CX; at a mean postoperative follow-up of 60 months, the satisfaction rates for patients and their partners were 97% and 91%, respectively. Vitarelli et al29 used the IIEF and EDITS to assess patient satisfaction at 27.6-month mean follow-up after 2-piece IPP placement; their findings suggested median postoperative IIEF and EDITS scores of 21.46 and 73.11, respectively, revealing a high level of satisfaction. More recently, Habous et al10 evaluated the satisfaction rate in a large cohort of 902 patients after IPP placement by asking a J Sex Med 2019;-:1e7
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Long-Term Follow-Up After Penile Prosthesis Implantation
Table 3. Cox regression analysis predicting inflatable penile prosthesis failure and stopping use of it Failure
Age Charlson comorbidity index, 0 vs 1 Body mass index Year of surgery Erectile dysfunction etiology Organic/vascular vs Peyronie’s disease Organic/vascular vs pelvic surgery
Stopped using
Hazard ratio
95% CI
P value
Hazard ratio
95% CI
P value
1.00 0.51 1.02 1.18
0.94e1.05 0.21e1.24 0.90e1.15 0.94e1.48
.9 .14 .7 .14
1.01 0.55 1.04 1.22
0.94e1.09 0.15e1.94 0.88e1.23 1.08e1.39
.7 .3 .6 .002
1.15 0.58
0.42e3.14 0.07e5.11
.8 .6
1.97 0.54
0.69e5.66 0.06e4.43
.1 .5
single question with a 5-point Likert scale (5 being the most satisfied) scoring system. Of relevance, 6 months after surgery, 97.5% of men were satisfied with their IPP; conversely, patients with any complication had a reduced rate of satisfaction (P < .001), and that reduction was even more pronounced with a major complication (P < .001). Overall, it is of major importance to emphasize that the use of either a non-validated questionnaire or a tool developed for a non-PPI population could lead to improper estimation of patient satisfaction. Indeed, with both strategies, it is possible to miss considering some relevant aspects of QoL, such as the patient’s relationship with his partner, as well as functional aspects, such as device operability and simplicity of use, all aspects that are relevant to IPP patients.8,30 To attempt to overcome these significant biases, we applied a tool specifically developed and validated to assess patient QoL and perceived prosthesis function,21 in order to provide more reliable data, especially in terms of patient satisfaction after PPI placement. Another strength of this study is that it involved the longest follow-up ever considered in this type of setting. The QoLSPP scores indicated high satisfaction in terms of prosthesis function, the couple’s sexual life, the patient’s relationship with the outside world, and the patient’s self-esteem. Moreover, our data show that about 60% of patients are likely to keep using the device after 20 years from surgery, further suggesting that patients are still satisfied with their treatment even several years after surgery. Interestingly, we observed that patients implanted in more recent years were more likely to quit using the prosthesis. In our opinion, this could reflect differences in terms of patient selection over time. Moreover, patients who have been reimplanted recently could be less satisfied with the device and thus more likely to stop using it. Our study is not without some limitations. The response rate for the telephone interview was low, thus potentially creating a selection bias; however, to overcome this, we compared the baseline characteristics of patients with and without complete follow-up data, and we did not observe any difference in terms of surgical approach and year of surgery, both factors with potential impact on postoperative outcomes. Patients lost to follow-up were significantly older and therefore probably less likely to J Sex Med 2019;-:1e7
keep using the device at long-term assessment, thus suggesting that our reported rate of patients regularly using the device at follow-up could be overestimated. Also, this study had a retrospective design and a relatively small number of patients. However, the use of a dedicated tool specifically developed and validated to assess patient QoL in men who have undergone IPP placement by a single experienced surgeon21 in a single center could help overcome any bias associated with such small numbers. In this context, having patients recall complications and rate their satisfaction during a telephone interview might represent a major bias, as such interviews have relatively low accuracy compared to face-to-face interviews. Our data are representative of a single-center, single-surgeon historical series but may not be generalizable to the series already published. Only 4 patients (7.8%) submitted to IPP placement after pelvic surgery, which differs from other series published so far; however, current analyses have demonstrated that ED etiology per se is not predictive of prosthesis survival. More specifically, of the 4 patients who were implanted after pelvic surgery, 1 patient’s IPP was explanted after 5 months due to pain, 1 patient required prosthesis replacement for a mechanical failure after 39 months, and 2 patients were still using the implant and reported active use after more than 10 years of follow-up.
CONCLUSION These current findings represent the longest follow-up to date using a dedicated tool to evaluate long-term complications and patient satisfaction after 3-piece IPP implantation. At a median follow-up time of 17 years, 1 out of 2 devices were still working properly, and up to 60% of patients were still using their devices with high satisfaction and adequate QoL outcomes. Both patients and physicians should be aware of the long life and overall positive outcomes of IPP. Corresponding Author: Andrea Salonia, MD, PhD, University Vita-Salute San Raffaele, Division of Experimental Oncology/ Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy. Tel: þ39 02 26435506; Fax: þ39 02 26432969; E-mail: salonia. [email protected]
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Conflict of Interest: None. Funding: None.
STATEMENT OF AUTHORSHIP Category 1 (a) Conception and Design Francesco Chierigo; Paolo Capogrosso; Andrea Salonia (b) Acquisition of Data Francesco Chierigo; Federico Dehò (c) Analysis and Interpretation of Data Francesco Chierigo; Paolo Capogrosso; Federico Belladelli; Pozzi Edoardo; Schifano Nicolò Category 2 (a) Drafting the Article Francesco Chierigo; Paolo Capogrosso; Andrea Salonia (b) Revising It for Intellectual Content Francesco Chierigo; Paolo Capogrosso; Andrea Salonia Category 3 (a) Final Approval of the Completed Article Francesco Chierigo; Paolo Capogrosso; Federico Dehò; Edoardo Pozzi; Nicolò Schifano; Federico Belladelli; Francesco Montorsi; Andrea Salonia
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29. Vitarelli A, Divenuto L, Fortunato F, et al. Long term patient satisfaction and quality of life with AMS700CX inflatable penile prosthesis. Arch Ital Urol Androl 2013;85:133-137. 30. Carvalheira A, Santana R, Pereira NM. Why are men satisfied or dissatisfied with penile implants? A mixed method study on satisfaction with penile prosthesis implantation. J Sex Med 2015;12:2474-2480.
SUPPLEMENTARY DATA Supplementary data related to this article can be found online at https://doi.org/10.1016/j.jsxm.2019.08.001.