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Critical Analysis of Satisfaction Assessment After Penile Prosthesis Surgery
Critical Analysis of Satisfaction Assessment After Penile Prosthesis Surgery William Akakpo, MD, Miguel A. Pineda, MD, and Arthur L. Burnett, MD, MBA
ABSTRACT
Introduction: Penile prosthesis implantation is believed to provide a high level of patient satisfaction. The International Index of Erectile Function and the Erectile Dysfunction Inventory of Treatment Satisfaction are two validated questionnaires that have been used to assess this outcome. The lack of a tool specifically validated for patients undergoing penile prosthesis surgery has led to the use of heterogeneous methods to assess patient satisfaction. Aim: To review the assessment of patient satisfaction with penile prosthesis surgery according to several factors. Methods: A literature review was performed through PubMed from January 2000 through February 2016 addressing patient satisfaction after penile prosthesis surgery. Main Outcome Measures: Patient satisfaction according to the characteristics of penile prosthesis devices and different clinical contexts. Results: Forty-eight articles were selected. Of these, 66.2% used non-validated questionnaires to assess patient satisfaction. Device characteristics, patient comorbidities, and partner profile are potential factors that can determine patient satisfaction. Conclusion: Patient satisfaction is a meaningful outcome of penile prosthesis surgery modulated by different conditions. The rigor of this assessment in the literature is limited. The validation of a scale designed for patients with penile prosthesis surgery is needed to optimize clinical practice. Akakpo W, Pineda MA, Burnett AL. Critical Analysis of Satisfaction Assessment After Penile Prosthesis Surgery. Sex Med Rev 2017; X:XXXeXXX. Copyright 2017, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.
Key Words: Penile Implant Surgery; Patient Satisfaction; Patient Outcomes Assessment; Quality of Life; Erectile Dysfunction
INTRODUCTION Penile prosthesis implantation is an excellent option for men with erectile dysfunction (ED) who do not respond to or have contraindications to conservative medical treatment or who prefer treatment with a penile prosthesis.1 Advances in device design and refined surgical technique have resulted in improved postoperative outcomes with fewer problems such as mechanical failure or infection.2,3 Thus, patients report levels of general satisfaction as high as 90%.4 Patient satisfaction is a difficult concept to define, but it is believed to refer to “an attitudinal response to the patient’s clinical encounter.”5 Patient satisfaction Received September 7, 2016. Accepted January 1, 2017. The James Buchanan Brady Urological Institute and Department of Urology, The Johns Hopkins School of Medicine, Baltimore, MD, USA Copyright ª 2017, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.sxmr.2017.01.001
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has come to represent a health care outcome that can be used to evaluate the quality of care.6 Various approaches have been used to evaluate patient satisfaction after penile prosthesis surgery. These approaches range from a single question to rigorously designed and validated questionnaires. Of these methods, the International Index of Erectile Function (IIEF)7 and the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS)8 are two validated tools often applied to this scenario. However, these instruments might not serve accurately for this assessment. The IIEF was developed using patients treated only with oral therapy. The EDITS was developed using patients treated with self-injection, vacuum erection devices, and oral medication. The lack of validation for patients undergoing penile prosthesis surgery has led some investigators to develop their own questionnaires.9,10 However, the comparability and repeatability of these alternative tools might be challenged in the current era of standardization of procedures. 1
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In this critical review, we analyzed studies that focused on patient satisfaction after penile prosthesis surgery. We evaluated satisfaction determinants of penile prosthesis surgery based on characteristics of this intervention. We further assessed the impact of prosthesis revision surgery on satisfaction outcomes. Then, we compared satisfaction outcomes after penile prosthesis implantation vs other treatments for ED. We also evaluated the relation of satisfaction ratings with clinical contexts associated with penile prosthesis surgery. To finish, we analyzed the influence of the partner on patient satisfaction.
SEARCH STRATEGY We performed a literature search on PubMed to identify relevant articles published from January 2000 through February 2016 that relate to satisfaction after penile prosthesis surgery. The research was conducted using the following Medical Subject Heading (MESH) terms, alone or in combination: penile prosthesis, patient satisfaction, patient outcomes assessment, and quality of life. Only articles written in English were included. Additional studies were identified from the reference lists of selected articles. Studies pertaining to penile prosthesis surgery in association with phalloplasty were excluded because of the unique clinical circumstances of this condition.11
STATE-OF-THE-ART KNOWLEDGE SYNTHESIS The IIEF is a 15-item self-administrated questionnaire designed to evaluate patients with ED and consists of five domains: erectile function (six items), orgasmic function (two items), sexual desire (two items), intercourse satisfaction (three items), and overall satisfaction (two items). The two last domains of this questionnaire (score range ¼ 1e25) are commonly used to assess the satisfaction aspect of ED therapy. The EDITS is an instrument designed to evaluate patient or partner satisfaction after ED treatments. The patient version contains 11 items including overall satisfaction, degree to which treatment met expectations, likelihood of treatment continuation, ease of use, satisfaction with onset of action, satisfaction with duration of action, impact of treatment on sexual confidence, partner satisfaction with treatment, partner acceptance of continuing treatment (by patient self-report), naturalness of erections, and naturalness of erection hardness. All 11 items are scored from 0 (no satisfaction) to 4 (high satisfaction). The EDITS score is the mean of responses to all items multiplied by 25 so that it ranges from a low of 0 (extremely low treatment satisfaction) to a high of 100 (extremely high treatment satisfaction). A total score higher than 50 is commonly defined as “satisfied with treatment” and a score no higher than 50 indicates “not satisfied with treatment.”12,13 In addition to these two scales, the Treatment Satisfaction Scale (TSS) was developed to complement other sexual dysfunction measurements such as quality of life (QoL), sexual functioning, overall satisfaction, and side effects.14 This scale consists of five items of the EDITS.
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After our search, 48 articles were selected. Of these, 21 (43.8%) used the IIEF or EDITS to assess satisfaction after penile prosthesis surgery. In seven of these articles, the IIEF satisfaction domains and EDITS score were used in combination, and in the other 14 articles either was used alone. In the 27 remaining articles, investigator-designed questionnaires were used. The TSS was not used in any selected study.
Characteristics of Penile Prosthesis Devices There are two main types of penile prosthesis devices. The most commonly used device in the United States is the inflatable penile prosthesis (IPP), which consists of cylinders inserted within the corpora cavernosa that can be filled with and emptied of fluid to achieve rigidity and flaccidity, respectively.15 Using a 37-item investigator-designed questionnaire reviewed by four experts in the field, no significant differences in patient satisfaction were shown with different brands of IPP devices.16 The other, less common type is the semirigid prosthesis, which is always rigid and can be bent downward when not engaging in sex and upward when ready for intercourse. Compared with IPPs, semirigid prostheses are associated with statistically significant (P < .05) lower satisfaction results, with reported EDITS scores of 78 ± 11 and 57 ± 8, respectively.17 Reasons for the difference in satisfaction could relate to the relatively more natural cosmetic penile rigidity and flaccidity of an IPP. This outcome could explain the decreasing numbers of semirigid prostheses implanted during the past 10 years. Nevertheless, a small study showed that most patients with a semirigid prosthesis felt completely satisfied and would have the same device implanted again if given the chance.18 However, failure to apply a validated scale providing numerical results was a shortcoming of this study. The two-piece IPP also provides a suitable satisfaction level documented by an EDITS score showing that more than 85% of patients provided an overall satisfaction rating as satisfied or higher.19,20 Poorer axial penile rigidity associated with this device compared with that of the three-piece IPP possibly influences patient satisfaction.21 A common complaint after penile prosthesis surgery, irrespective of device type, is penile shortening.22 The aspect of QoL after three-piece IPP surgery also was explored. A questionnaire exploring four components of QoL based on the World Health Organization’s definition of health was administered to patients who had undergone three-piece IPP surgery and found that 85% of answers were on the positive side of the scale.23 In addition, independent of prosthesis type, satisfaction outcomes can be assessed based on the timeline of having undergone penile prosthesis surgery. Satisfaction measured with the EDITS questionnaire was statistically higher at 12 months than at 3 or 6 months after surgery.24,25 In another study of 500 patients, almost all patients reported some relational problems during the first month after penile implant surgery, leading to lower satisfaction.26 Some long-term studies (mean follow-up range ¼ 59e105 months) reported consistently high levels of satisfaction, Sex Med Rev 2017;-:1e8
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Satisfaction After Penile Prosthesis Surgery
but only one used a validated tool with a mean EDITS score of 73.11.27e29 Thus, patient satisfaction tends to increase in the first year, and after which it reaches a plateau. In review, satisfaction ratings with penile prosthesis surgery correlate with certain characteristics of this surgery. Of all device types, the three-piece IPP yields the highest satisfaction rating. These findings appear to be comparable in different countries across the world.30e33
Revision Surgery Satisfaction can be affected in patients who have undergone multiple prosthesis surgeries. In one study, 39 patients underwent revision surgery (69% underwent one revision procedure, 21% underwent two revision procedures, and 10% three revision procedures) and were evaluated using four of the five questions of the satisfaction domain of the IIEF questionnaire (maximum score ¼ 20).34 Twenty-six patients responded with a mean postoperative IIEF satisfaction domain score of 15.7 ± 5.6, and 77% of patients expressed that they were moderately or very satisfied with their overall sex life. However, patients with penile implants that were placed into fibrotic corporal bodies had a statistically significantly (P ¼ .010) lower IIEF satisfaction domain score. Fibrotic corporal bodies are often found during revision surgery, but in this study these were mainly associated with patients who had a prior penile implant removed because of infection. The main reason for this dissatisfaction was the loss of penile length from fibrosis. Some evidence suggests that revision surgery permits patients to achieve levels of satisfaction equivalent to first-time surgery rates. This was highlighted in a study comparing satisfaction in 110 patients undergoing a first penile implantation and 39 undergoing reimplantation.35 Seventy-nine percent of patients who underwent first-time implantation and 80% of patients who underwent reimplantation reported satisfactory sexual intercourse, and 73.7% and 70% of patients would undergo the procedure again if the IPP failed, respectively. High patient satisfaction ratings after revision surgery are obtained when precise information related to surgery outcomes and potential complications are discussed with patients before surgery. Thus, previous positive experiences of the prosthesis before device revision was done are sustained.36 The fact that a large proportion of patients with functional penile prosthesis devices reported they would undergo the same surgery again if necessary supports this idea. Moreover, it is hardly surprising to note that removal of the prosthesis without replacement leads to poor satisfaction scores.37
Penile Prosthesis Surgery vs Other Medical Treatments Medical treatments are often used before penile prosthesis implantation is considered. Some studies have explored the difference in satisfaction between penile prosthesis implantation Sex Med Rev 2017;-:1e8
and other ED treatments. One such study compared satisfaction rates of patients treated with oral sildenafil, intracavernous prostaglandin E1, and IPP implantation. Patients managed with the IPP had previously failed sildenafil therapy and had a significantly higher (P < .001) mean EDITS score (82.03 ± 14.41) than patients treated only with sildenafil (61.51 ± 15.98) or intracavernous injection (58.16 ± 18.25) at a follow-up of 20 months.38 In another study, implantation of a penile prosthesis in a small number of patients without prior ED treatment also led to high EDITS and IIEF satisfaction domain scores but not the highest compared with non-surgical ED treatment.39 The main causes of dissatisfaction were technical errors, pain, or psychological problems. Satisfaction ratings were obtained in patients who at 6 months after nerve-sparing radical prostatectomy (RP) received oral tadalafil or penile prosthesis devices. None of these patients had previously used phosphodiesterase type 5 inhibitors. They were evaluated using three domains of the IIEF (erectile function, intercourse satisfaction, and overall satisfaction). Preoperative and postoperative (6 months) IIEF scores were not different between the tadalafil and penile prosthesis groups but became significantly higher (P < .001) in the penile prosthesis group at 12, 18, and 24 months.40 Interpretation of these three studies comparing penile prosthesis implantation with medical therapies is problematic. Patients who have undergone penile prosthesis implantation likely represent a more severe extent of ED compared with that of those actively undergoing medical management. However, in two of these studies, pre-therapeutic erectile function was not mentioned but patients received different treatments with varying efficacies (ranging from vacuum therapy to penile prosthesis) based on patients’ choice. Thus, patients might not have equivalent erectile function at baseline, which is problematic and does not allow comparison between groups. Conversely, the use of ED drug therapy before penile prosthesis implantation could influence patient satisfaction.
Comorbidities Comorbidity status could be relevant in understanding satisfaction outcomes after penile prosthesis surgery. The review of this topic suggests several categories of interest, which include Peyronie disease (PD), prior RP, body mass index higher than 30 kg/m2, and age older than 70 years. PD is a major comorbidity that is considered by some to be associated with dissatisfaction after penile prosthesis surgery. PD often features complex deformities that can influence postoperative expectations and decrease satisfaction after penile prosthesis surgery.41 In one study, dissatisfaction after surgery was associated with various complaints such as decreased penile dimensions, decreased penile sensitivity, and persistent penile deviation.42 However, in this study, patients were managed exclusively with semirigid prosthesis devices, which can be a confounding factor because of the association of these devices
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with a lower satisfaction level. In contrast, the implantation of a three-piece IPP with the addition of penile modeling for PD appears to provide a high level of satisfaction in the same order of magnitude as seen with penile implant surgeries without penile deformities.43,44 Similarly, three-piece IPP with synchronous penile plication or tunica albuginea incision leads to excellent satisfaction rates based on overall satisfaction measurement or IIEF score.45,46 Interestingly, similar good results for patient overall satisfaction were reported with semirigid soft penile prosthesis devices in two studies.47,48 However, the assessment of overall satisfaction was performed using an overall single question, which does not confer the precision of a validated questionnaire. Data are lacking to affirm whether PD leads to a lower satisfaction level, and PD is sometimes an exclusion criterion in studies assessing satisfaction after penile prosthesis implantation. Setting proper postoperative expectations seems to be particularly advantageous for this group of patients to optimize postoperative satisfaction level.49,50 Prior RP also has been proposed to be a factor negatively influencing satisfaction after penile prosthesis surgery. In one study analyzing several comorbidities, EDITS score assessed at least 6 months postoperatively was statistically lower in the RP group compared with the general implant population.51 Major comorbidities occurring in the “general” group included hypertension, dyslipidemia, vascular disease, and diabetes. A consideration for patients with RP, which could contribute to dissatisfaction after penile prosthesis implantation, is that 40% to 70% of patients with RP had penile shortening after prostate surgery.52 Even after penile prosthesis surgery, patients with RP reported most frequently a subjective penile length loss (P ¼ .03), which contributed to a significantly lower EDITS score (P ¼ .008).53 Two others studies compared satisfaction after penile prosthesis surgery in patients with RP vs vasculogenic ED. The first study is consistent with the initial findings showing that patients who had undergone RP had a significantly lower (P ¼ .03) EDITS score (58 ± 10 vs 71 ± 8).54 In the second study, the total score of the IIEF questionnaire was significantly lower (P ¼ .005) in patients with RP.55 IIEF satisfaction domain score and the positive response rate to a single satisfaction question were lower in patients with RP. However, these trends were not statistically significant (P ¼ .09 and P ¼ .3 respectively), whereas the IIEF orgasmic function domain score was significantly lower (P < .001) in patients with RP. Compared with the first study, the main difference in patient characteristics is that patients with RP were significantly (P ¼ .001) older than patients with vasculogenic ED. This could skew the comparison between groups and explain the absence of significant differences between patients with RP and those with vasculogenic ED. After RP, patients have a major and abrupt loss of their erectile function and their ejaculation, often considered by patients as orgasm, which likely has a negative psychological impact.56 This could explain why patients with RP have lower satisfaction levels compared with patients who have progressively lost their erectile function because of a chronic
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disease. Psychological counseling can be helpful to deal with this problem in this specific group. Similarly, obesity (body mass index > 30 kg/m2) has been associated with dissatisfaction after penile prosthesis surgery. This also has been shown through lower EDITS scores in this group compared with the general population.51 Some data indicate that obese patients have a higher risk for ED than those with a normal body mass index (25 kg/m2) because of abnormal endothelial function and psychological factors.57,58 Such factors could contribute to impairments in sexual QoL.59 Thus, obese patients might harbor lower satisfaction at baseline before penile implantation that could explain lower postoperative satisfaction. Management of ED in the aging population (>70 years) can be challenging.60 On the one hand, certain comorbidities observed in older individuals such as coronary artery disease medicated with nitrates might contraindicate some conservative medical therapies for ED (eg, phosphodiesterase type 5 inhibitors). On the other hand, decreased dexterity with aging could confound the operation of an IPP pump. Although difficulty in manipulating the device might lead to lower satisfaction in older men, this belief is not affirmed. In fact, a satisfaction assessment specifically in patients older than 70 years showed excellent results with a mean EDITS score of 75.20.61 Similarly, using a scale from 1 to 5 (with 5 meaning very satisfied), 32 of 35 patients 71 to 86 years of age rated their overall satisfaction as at least 3 (average score ¼ 4.3).62 In another study comparing satisfaction with IPP surgery between men younger and older than 75 years, no difference was found between these two groups.63 On a scale exploring overall satisfaction ranging from 1 to 5, with 5 meaning very satisfied, 90% and 93% of patients, respectively, scored at least 4. Question 1 of the EDITS score also was used and produced comparable results. In addition, in another scale ranging from 1 to 5, with 5 meaning very easy to use, 93% of patients older than 75 years scored 4 or 5. Device improvements, particularly with respect to features of the pump, could be associated with increasingly observed ease of use.64 Review of these data does not support the fact that older patients are more prone to dissatisfaction after surgery. After cognitive and motor performance evaluation in older men with ED, penile prosthesis implantation, including IPP devices, should be included in the therapeutic arsenal. Although satisfaction assessments after penile prosthesis surgery in older patients and those with PD are divergent, obese patients and those after RP might be predisposed toward dissatisfaction as a result of their preoperative sexual dysfunction status and distress concerning their overall adverse health conditions and management.
Influence of the Partner on Patient Satisfaction ED is a couple’s issue in regard to management of the problem and assessment of satisfaction after treatment. Of 69 couples who were evaluated at least 1 year after primary penile prosthesis surgery, mean EDITS scores were 75.48 ± 20.54 Sex Med Rev 2017;-:1e8
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Table 1. Patient satisfaction with penile prosthesis surgery according to several factors Conditions
Main findings
Characteristics of penile prosthesis devices
Among all devices, 3-piece IPPs are the most frequently implanted in the United States and have the highest satisfaction rating.15,18 No significant differences in satisfaction ratings are apparent across IPP brands.16 Patient satisfaction evolves over time. EDITS scores are statistically higher at 12 mo than at 3 or 6 mo after surgery.24,25 With the exception of patients with new implants inserted into fibrotic corporal bodies, revision surgery does not significantly affect patient satisfaction provided precise preoperative information on the surgery and potential complications are provided to the patient. The loss of penile length from fibrosis is the main reason for dissatisfaction.34 IPP leads to higher IIEF scores than tadalafil after RP.40
Revision surgery
Penile prosthesis surgery vs other medical treatment
Comorbidities
Partner profile
Unless equivalent pre-therapeutic erectile function of patients is documented, interpretation of data is problematic. Analysis of the literature shows that patients with RP and obese patients tend to be less satisfied after the surgery because of their preoperative status.51,54 However, there is no evidence to support dissatisfaction in old patients and those with PD.45,46 The partner can influence patient satisfaction and should be included in the assessment.8,67 A correlation of EDITS scores exists between patients and partners.65 Patient satisfaction also is correlated with partner’s FSFI score.66
EDITS ¼ Erectile Dysfunction Inventory of Treatment Satisfaction; FSFI ¼ Female Sexual Function Index; IIEF ¼ International Index of Erectile Function; IPP ¼ inflatable penile prosthesis; PD ¼ Peyronie’s disease; RP ¼ radical prostatectomy.
and 70.00 ± 22.92 in patients and partners, respectively.65 This analysis showed a linear correlation between the degrees of satisfaction for patients and partners except in married couples, in which female satisfaction was lower. A possible reason for this finding, invoked by the investigators, is the possibly lower sexual interest of married couples amid the routine of sexual activity associated with organic changes in women during aging. A different study correlated patient satisfaction with female sexual function through a telephone survey.66 This study involved the Female Sexual Function Index (FSFI), which is a 19-item validated scale used to assess key dimensions of sexual function (desire, arousal, lubrication, orgasm, satisfaction, and pain).67 The analysis suggested a direct correlation between the patient’s degree of satisfaction and FSFI scores. In particular, unsatisfied patients are more likely to have partners with sexual dysfunction. However, it can be questioned whether being unsatisfied with a penile prosthesis, for whatever reason, could be the cause of female sexual dysfunction reflected by the FSFI score. In any case, these findings suggest the importance of considering the partner in the management and follow-up of patients after penile prosthesis surgery.
DISCUSSION Satisfaction is understood to be a major factor in assessing outcomes of penile prosthesis surgery, although this review of the current literature has suggested that the rigor of this assessment is limited. Studies dealing with satisfaction after penile prosthesis surgery emphasize relevant considerations but use a wide heterogeneity of methods in making this assessment. Sex Med Rev 2017;-:1e8
The assessment of satisfaction among these studies highlights potential factors that could determine patient satisfaction, such as device type, ED etiology, and partner profile (Table 1). IPP devices seem to provide a better level of satisfaction than semirigid prosthesis devices without a negative effect from revision surgery. In addition, results were comparable irrespective of the device brand.68,69 In addition, it was interesting to note that obesity and history of RP can be linked with lower satisfaction levels. Conversely, there is no evidence to support the notion that patients with PD and aging patients are at risk for dissatisfaction after penile prosthesis surgery. Despite these findings, the wide variety of satisfaction assessments and the fact that only 43.8% of studies in our review used a validated questionnaire merit some commentary. In a previous review of nine articles on satisfaction, only one study used a validated questionnaire to assess satisfaction.70 The fact is that the EDITS and IIEF questionnaires were developed for the evaluation of patients with ED undergoing medical treatments and at least two questions of the EDITS are inappropriate to assess satisfaction in patients with penile prosthesis devices. Questions 5 and 6 illustrate this perfectly: “During the past 4 weeks, how satisfied have you been with how quickly the treatment works?” and “During the past 4 weeks, how satisfied have you been with how long the treatment lasts?” It would be difficult for patients with penile prosthesis to answer these questions. In fact, they control the onset and the duration of their erection through the mechanical operation of their devices. Similarly, the TSS, which includes a module evaluating the quality of ejaculation, would not be applicable for patients with RP. Conversely, the question of whether a patient would recommend the treatment to a friend was
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not selected by experts in the EDITS study because it was considered not important in the domain of satisfaction. This question could be judged irrelevant for a medical treatment but might have more importance for an irreversible intervention such as penile prosthesis surgery.71 More than 15 years after the development of the EDITS and IIEF questionnaires, this exercise suggests that it might be time to revise our tools and develop a new validated scale with Likert items that will be most applicable to this field. This sort of evaluation should include such important aspects of satisfaction with penile prosthesis as device operability, natural sensibility before and during intercourse, and orgasm achievement. This new tool also should assess specific fields of partner satisfaction such as responsiveness to the device in particular during intercourse. The development of this new questionnaire will need to involve direct input from patients. For this purpose, focus groups with patients and physicians could be beneficial. This interaction between participants could lead to a candid discussion that is omitted in conventional conditions.72 Moreover, because satisfaction with penile prosthesis surgery is a dynamic process evolving over time, assessments should be done at specific times before and after surgery. For this purpose, the assessment of patient satisfaction must be standardized. This standardization also includes patient assessment under the same conditions. Indeed, in some studies satisfaction was assessed by a telephonic survey conducted by an independent interviewer to decrease bias, whereas other studies completed this evaluation during a medical follow-up appointment in the presence of the surgeon who performed the implantation. It is apparent that answers can be different according to the way in which the data are gathered.
CONCLUSION In this review, we showed that satisfaction is a meaningful end point for reporting outcomes of penile prosthesis surgery. Although satisfaction with penile prosthesis surgery has been studied previously, the assessment has not been vigorous. Indeed, tools that have been used are not specific to assess satisfaction after penile prosthesis surgery. Satisfaction parameters in patients treated for ED medically cannot be transferred to patients treated with a penile prosthesis. The current assessment of satisfaction with the penile prosthesis has suggested potential determinants of satisfaction for this treatment, but this remains inadequate to determine the level of satisfaction accurately and comprehensively. New satisfaction assessment tools specifically designed to evaluate the impact of penile prosthesis surgery should be developed and take into account key parameters that can influence results. Corresponding Author: Arthur L. Burnett, MD, MBA, The James Buchanan Brady Urological Institute and Department of Urology, The Johns Hopkins School of Medicine, 601 North Caroline Street, Baltimore, MD 21205, USA. Tel: þ1-410-6143986; Fax: þ1-410-614-3695; E-mail: [email protected]
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Conflicts of Interest: Dr Burnett received research support from Boston Scientific (American Medical System). Funding: None.
STATEMENT OF AUTHORSHIP Category 1 (a) Conception and Design William Akakpo; Miguel A. Pineda; Arthur L. Burnett (b) Acquisition of Data William Akakpo; Miguel A. Pineda; Arthur L. Burnett (c) Analysis and Interpretation of Data William Akakpo; Miguel A. Pineda; Arthur L. Burnett Category 2 (a) Drafting the Article William Akakpo; Miguel A. Pineda; Arthur L. Burnett (b) Revising It for Intellectual Content William Akakpo; Miguel A. Pineda; Arthur L. Burnett Category 3 (a) Final Approval of the Completed Article William Akakpo; Miguel A. Pineda; Arthur L. Burnett
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33. Chiang HS, Wu CC, Wen TC. 10 Years of experience with penile prosthesis implantation in Taiwanese patients. J Urol 2000; 163:476-480.
18. Bozkurt IH, Arslan B, Yonguc T, et al. Patient and partner outcome of inflatable and semi-rigid penile prosthesis in a single institution. Int Braz J Urol 2015;41:535-541. 19. Falcone M, Rolle L, Ceruti C, et al. Prospective analysis of the surgical outcomes and patients’ satisfaction rate after the AMS Spectra penile prosthesis implantation. Urology 2013; 82:373-376. 20. Levine LA, Estrada CR, Morgentaler A. Mechanical reliability and safety of, and patient satisfaction with the Ambicor inflatable penile prosthesis: results of a 2 center study. J Urol 2001;166:932-937. 21. Lux M, Reyes-Vallejo L, Morgentaler A, et al. Outcomes and satisfaction rates for the redesigned 2-piece penile prosthesis. J Urol 2007;177:262-266. 22. Al Ansari A, Talib RA, Canguven O, et al. Axial penile rigidity influences patient and partner satisfaction after penile prosthesis implantation. Arch Ital Urol Androl 2013;85:138-142. 23. Caraceni E, Utizi L. A questionnaire for the evaluation of quality of life after penile prosthesis implant: Quality of Life and Sexuality with Penile Prosthesis (QoLSPP): to what extent does the implant affect the patient’s life? J Sex Med 2014;11:1005-1012. 24. Knoll LD, Henry G, Culkin D, et al. Physician and patient satisfaction with the new AMS 700 momentary squeeze inflatable penile prosthesis. J Sex Med 2009;6:1773-1778. 25. Mulhall JP, Ahmed A, Branch J, et al. Serial assessment of efficacy and satisfaction profiles following penile prosthesis surgery. J Urol 2003;169:1429-1433. Sex Med Rev 2017;-:1e8
34. Kava BR, Yang Y, Soloway CT. Efficacy and patient satisfaction associated with penile prosthesis revision surgery. J Sex Med 2007;4:509-518. 35. Lledó-García E, Jara-Rascón J, Moncada Iribarren I, et al. Penile prosthesis first and replacement surgeries: analysis of patient and partner satisfaction. J Sex Med 2015;12: 1646-1653. 36. Caire AA, Boonjindasup A, Hellstrom WJ. Does a replacement or revision of an inflatable penile prosthesis lead to decreased patient satisfaction? Int J Impot Res 2011;23:39-42. 37. Minervini A, Ralph DJ, Pryor JP. Outcome of penile prosthesis implantation for treating erectile dysfunction: experience with 504 procedures. BJU Int 2006;97:129-133. 38. 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. 39. Hassan A, El-Hadidy M, El-Deeck BS, et al. Couple satisfaction to different therapeutic modalities for organic erectile dysfunction. J Sex Med 2008;5:2381-2391. 40. Megas G, Papadopoulos G, Stathouros G, et al. Comparison of efficacy and satisfaction profile, between penile prosthesis implantation and oral PDE5 inhibitor tadalafil therapy, in men with nerve-sparing radical prostatectomy erectile dysfunction. BJU Int 2013;112:E169-E176. 41. Levine LA, Benson J, Hoover C. Inflatable penile prosthesis placement in men with Peyronie’s disease and drug-resistant erectile dysfunction: a single-center study. J Sex Med 2010; 7:3775-3783.
8 42. Montorsi F, Guazzoni G, Bergamaschi F, et al. Patient-partner satisfaction with semirigid penile prostheses for Peyronie’s disease: a 5-year followup study. J Urol 1993;150:1819-1821. 43. Chung E, Solomon M, DeYoung L, et al. Comparison between AMS 700TM CX and ColoplastTM Titan inflatable penile prosthesis for Peyronie’s disease treatment and remodeling: clinical outcomes and patient satisfaction. J Sex Med 2013; 10:2855-2860. 44. Usta MF, Bivalacqua TJ, Sanabria J, et al. Patient and partner satisfaction and long-term results after surgical treatment for Peyronie’s disease. Urology 2003;62:105-109. 45. 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;11:1593-1598. 46. Djordjevic ML, Kojovic V. Penile prosthesis implantation and tunica albuginea incision without grafting in the treatment of Peyronie’s disease with erectile dysfunction. Asian J Androl 2013;15:391-394.
Akakpo et al 57. Bacon CG, Mittleman MA, Kawachi I, et al. Sexual function in men older than 50 years of age: results from the health professionals’ follow-up study. Ann Intern Med 2003;139: 161-168. 58. Esposito K, Giugliano F, Di Palo C, et al. Effect of lifestyle changes on erectile dysfunction in obese men: a randomized controlled trial. JAMA 2004;291:2978-2984. 59. Kolotkin RL, Binks M, Crosby RD, et al. Obesity and sexual quality of life. Obesity (Silver Spring) 2006;14:472-479. 60. Onder G, Lattanzio F, Battaglia M, et al. The risk of adverse drug reactions in older patients: beyond drug metabolism. Curr Drug Metab 2011;12:647-651. 61. Al-Najar A, Naumann CM, Kaufmann S, et al. Should being aged over 70 years hinder penile prosthesis implantation? BJU Int 2009;104:834-837. 62. Villarreal HG, Jones L. Outcomes of and satisfaction with the inflatable penile prosthesis in the elderly male. Adv Urol 2012; 2012:240963.
47. Grasso M, Lania C, Fortuna F, et al. Preservation of cavernosal erectile function after soft penile prosthesis implant in Peyronie’s disease: long-term followup. Adv Urol 2008:646052.
63. Chung E, Solomon M, DeYoung L, et al. Clinical outcomes and patient satisfaction rates among elderly male aged 75 years with inflatable penile prosthesis implant for medically refractory erectile dysfunction. World J Urol 2014;32:173-177.
48. Austoni E, Colombo F, Romanò AL, et al. Soft prosthesis implant and relaxing albugineal incision with saphenous grafting for surgical therapy of Peyronie’s disease: a 5-year experience and long-term follow-up on 145 operated patients. Eur Urol 2005;47:223-229.
64. Ohl DA, Brock G, Ralph D, et al. Prospective evaluation of patient satisfaction, and surgeon and patient trainer assessment of the Coloplast Titan one touch release three-piece inflatable penile prosthesis. J Sex Med 2012;9:2467-2474.
49. Kramer AC, Schweber A. Patient expectations prior to Coloplast Titan penile prosthesis implant predicts postoperative satisfaction. J Sex Med 2010;7:2261-2266.
65. Vakalopoulos I, Kampantais S, Ioannidis S, et al. High patient satisfaction after inflatable penile prostheses implantation correlates with female partner satisfaction. J Sex Med 2013; 10:2774-2781.
50. 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.
66. Gittens P, Moskovic DJ, Avila D Jr, et al. Favorable female sexual function is associated with patient satisfaction after inflatable penile prosthesis implantation. J Sex Med 2011; 8:1996-2001.
51. Akin-Olugbade O, Parker M, Guhring P, et al. Determinants of patient satisfaction following penile prosthesis surgery. J Sex Med 2006;3:743-748.
67. Wiegel M, Meston C, Rosen R. The Female Sexual Function Index (FSFI): cross-validation and development of clinical cutoff scores. J Sex Marital Ther 2005;31:1-20.
52. Mulhall JP. Penile length changes after radical prostatectomy. BJU Int 2005;96:472-474.
68. Lindeborg L, Fode M, Fahrenkrug L, et al. Satisfaction and complications with the Titan® one-touch release penile implant. Scand J Urol 2014;48:105-109.
53. Deveci S, Martin D, Parker M, et al. Penile length alterations following penile prosthesis surgery. Eur Urol 2007;51: 1128-1131. 54. Bozkurt IH, Arslan B, Kozacioglu Z, et al. Does the etiology affect the outcome and satisfaction rates of penile prosthesis implantation surgery? Kaohsiung J Med Sci 2014;30: 570-573. 55. Menard J, Tremeaux JC, Faix A, et al. Erectile function and sexual satisfaction before and after penile prosthesis implantation in radical prostatectomy patients: a comparison with patients with vasculogenic erectile dysfunction. J Sex Med 2011;8:3479-3486. 56. Alwaal A, Breyer BN, Lue TF. Normal male sexual function: emphasis on orgasm and ejaculation. Fertil Steril 2015; 104:1051-1060.
69. Bettocchi C, Palumbo F, Spilotros M, et al. Patient and partner satisfaction after AMS inflatable penile prosthesis implant. J Sex Med 2010;7:304-309. 70. Bernal RM, Henry GD. Contemporary patient satisfaction rates for three-piece inflatable penile prostheses. Adv Urol 2012; 2012:707321. 71. Jensen JB, Madsen SS, Larsen EH, et al. Patient and partner satisfaction with the Mentor Alpha-1 inflatable penile prosthesis. Scand J Urol Nephrol 2005;39:66-68. 72. Carbone F, Holvoet L, Vandenberghe A, et al. Functional dyspepsia: outcome of focus groups for the development of a questionnaire for symptom assessment in patients suffering from postprandial distress syndrome (PDS). Neurogastroenterol Motil 2014;26:1266-1274.
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ABSTRACT
Introduction: Penile prosthesis implantation is believed to provide a high level of patient satisfaction. The International Index of Erectile Function and the Erectile Dysfunction Inventory of Treatment Satisfaction are two validated questionnaires that have been used to assess this outcome. The lack of a tool specifically validated for patients undergoing penile prosthesis surgery has led to the use of heterogeneous methods to assess patient satisfaction. Aim: To review the assessment of patient satisfaction with penile prosthesis surgery according to several factors. Methods: A literature review was performed through PubMed from January 2000 through February 2016 addressing patient satisfaction after penile prosthesis surgery. Main Outcome Measures: Patient satisfaction according to the characteristics of penile prosthesis devices and different clinical contexts. Results: Forty-eight articles were selected. Of these, 66.2% used non-validated questionnaires to assess patient satisfaction. Device characteristics, patient comorbidities, and partner profile are potential factors that can determine patient satisfaction. Conclusion: Patient satisfaction is a meaningful outcome of penile prosthesis surgery modulated by different conditions. The rigor of this assessment in the literature is limited. The validation of a scale designed for patients with penile prosthesis surgery is needed to optimize clinical practice. Akakpo W, Pineda MA, Burnett AL. Critical Analysis of Satisfaction Assessment After Penile Prosthesis Surgery. Sex Med Rev 2017; X:XXXeXXX. Copyright 2017, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.
Key Words: Penile Implant Surgery; Patient Satisfaction; Patient Outcomes Assessment; Quality of Life; Erectile Dysfunction
INTRODUCTION Penile prosthesis implantation is an excellent option for men with erectile dysfunction (ED) who do not respond to or have contraindications to conservative medical treatment or who prefer treatment with a penile prosthesis.1 Advances in device design and refined surgical technique have resulted in improved postoperative outcomes with fewer problems such as mechanical failure or infection.2,3 Thus, patients report levels of general satisfaction as high as 90%.4 Patient satisfaction is a difficult concept to define, but it is believed to refer to “an attitudinal response to the patient’s clinical encounter.”5 Patient satisfaction Received September 7, 2016. Accepted January 1, 2017. The James Buchanan Brady Urological Institute and Department of Urology, The Johns Hopkins School of Medicine, Baltimore, MD, USA Copyright ª 2017, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.sxmr.2017.01.001
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has come to represent a health care outcome that can be used to evaluate the quality of care.6 Various approaches have been used to evaluate patient satisfaction after penile prosthesis surgery. These approaches range from a single question to rigorously designed and validated questionnaires. Of these methods, the International Index of Erectile Function (IIEF)7 and the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS)8 are two validated tools often applied to this scenario. However, these instruments might not serve accurately for this assessment. The IIEF was developed using patients treated only with oral therapy. The EDITS was developed using patients treated with self-injection, vacuum erection devices, and oral medication. The lack of validation for patients undergoing penile prosthesis surgery has led some investigators to develop their own questionnaires.9,10 However, the comparability and repeatability of these alternative tools might be challenged in the current era of standardization of procedures. 1
2
In this critical review, we analyzed studies that focused on patient satisfaction after penile prosthesis surgery. We evaluated satisfaction determinants of penile prosthesis surgery based on characteristics of this intervention. We further assessed the impact of prosthesis revision surgery on satisfaction outcomes. Then, we compared satisfaction outcomes after penile prosthesis implantation vs other treatments for ED. We also evaluated the relation of satisfaction ratings with clinical contexts associated with penile prosthesis surgery. To finish, we analyzed the influence of the partner on patient satisfaction.
SEARCH STRATEGY We performed a literature search on PubMed to identify relevant articles published from January 2000 through February 2016 that relate to satisfaction after penile prosthesis surgery. The research was conducted using the following Medical Subject Heading (MESH) terms, alone or in combination: penile prosthesis, patient satisfaction, patient outcomes assessment, and quality of life. Only articles written in English were included. Additional studies were identified from the reference lists of selected articles. Studies pertaining to penile prosthesis surgery in association with phalloplasty were excluded because of the unique clinical circumstances of this condition.11
STATE-OF-THE-ART KNOWLEDGE SYNTHESIS The IIEF is a 15-item self-administrated questionnaire designed to evaluate patients with ED and consists of five domains: erectile function (six items), orgasmic function (two items), sexual desire (two items), intercourse satisfaction (three items), and overall satisfaction (two items). The two last domains of this questionnaire (score range ¼ 1e25) are commonly used to assess the satisfaction aspect of ED therapy. The EDITS is an instrument designed to evaluate patient or partner satisfaction after ED treatments. The patient version contains 11 items including overall satisfaction, degree to which treatment met expectations, likelihood of treatment continuation, ease of use, satisfaction with onset of action, satisfaction with duration of action, impact of treatment on sexual confidence, partner satisfaction with treatment, partner acceptance of continuing treatment (by patient self-report), naturalness of erections, and naturalness of erection hardness. All 11 items are scored from 0 (no satisfaction) to 4 (high satisfaction). The EDITS score is the mean of responses to all items multiplied by 25 so that it ranges from a low of 0 (extremely low treatment satisfaction) to a high of 100 (extremely high treatment satisfaction). A total score higher than 50 is commonly defined as “satisfied with treatment” and a score no higher than 50 indicates “not satisfied with treatment.”12,13 In addition to these two scales, the Treatment Satisfaction Scale (TSS) was developed to complement other sexual dysfunction measurements such as quality of life (QoL), sexual functioning, overall satisfaction, and side effects.14 This scale consists of five items of the EDITS.
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After our search, 48 articles were selected. Of these, 21 (43.8%) used the IIEF or EDITS to assess satisfaction after penile prosthesis surgery. In seven of these articles, the IIEF satisfaction domains and EDITS score were used in combination, and in the other 14 articles either was used alone. In the 27 remaining articles, investigator-designed questionnaires were used. The TSS was not used in any selected study.
Characteristics of Penile Prosthesis Devices There are two main types of penile prosthesis devices. The most commonly used device in the United States is the inflatable penile prosthesis (IPP), which consists of cylinders inserted within the corpora cavernosa that can be filled with and emptied of fluid to achieve rigidity and flaccidity, respectively.15 Using a 37-item investigator-designed questionnaire reviewed by four experts in the field, no significant differences in patient satisfaction were shown with different brands of IPP devices.16 The other, less common type is the semirigid prosthesis, which is always rigid and can be bent downward when not engaging in sex and upward when ready for intercourse. Compared with IPPs, semirigid prostheses are associated with statistically significant (P < .05) lower satisfaction results, with reported EDITS scores of 78 ± 11 and 57 ± 8, respectively.17 Reasons for the difference in satisfaction could relate to the relatively more natural cosmetic penile rigidity and flaccidity of an IPP. This outcome could explain the decreasing numbers of semirigid prostheses implanted during the past 10 years. Nevertheless, a small study showed that most patients with a semirigid prosthesis felt completely satisfied and would have the same device implanted again if given the chance.18 However, failure to apply a validated scale providing numerical results was a shortcoming of this study. The two-piece IPP also provides a suitable satisfaction level documented by an EDITS score showing that more than 85% of patients provided an overall satisfaction rating as satisfied or higher.19,20 Poorer axial penile rigidity associated with this device compared with that of the three-piece IPP possibly influences patient satisfaction.21 A common complaint after penile prosthesis surgery, irrespective of device type, is penile shortening.22 The aspect of QoL after three-piece IPP surgery also was explored. A questionnaire exploring four components of QoL based on the World Health Organization’s definition of health was administered to patients who had undergone three-piece IPP surgery and found that 85% of answers were on the positive side of the scale.23 In addition, independent of prosthesis type, satisfaction outcomes can be assessed based on the timeline of having undergone penile prosthesis surgery. Satisfaction measured with the EDITS questionnaire was statistically higher at 12 months than at 3 or 6 months after surgery.24,25 In another study of 500 patients, almost all patients reported some relational problems during the first month after penile implant surgery, leading to lower satisfaction.26 Some long-term studies (mean follow-up range ¼ 59e105 months) reported consistently high levels of satisfaction, Sex Med Rev 2017;-:1e8
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Satisfaction After Penile Prosthesis Surgery
but only one used a validated tool with a mean EDITS score of 73.11.27e29 Thus, patient satisfaction tends to increase in the first year, and after which it reaches a plateau. In review, satisfaction ratings with penile prosthesis surgery correlate with certain characteristics of this surgery. Of all device types, the three-piece IPP yields the highest satisfaction rating. These findings appear to be comparable in different countries across the world.30e33
Revision Surgery Satisfaction can be affected in patients who have undergone multiple prosthesis surgeries. In one study, 39 patients underwent revision surgery (69% underwent one revision procedure, 21% underwent two revision procedures, and 10% three revision procedures) and were evaluated using four of the five questions of the satisfaction domain of the IIEF questionnaire (maximum score ¼ 20).34 Twenty-six patients responded with a mean postoperative IIEF satisfaction domain score of 15.7 ± 5.6, and 77% of patients expressed that they were moderately or very satisfied with their overall sex life. However, patients with penile implants that were placed into fibrotic corporal bodies had a statistically significantly (P ¼ .010) lower IIEF satisfaction domain score. Fibrotic corporal bodies are often found during revision surgery, but in this study these were mainly associated with patients who had a prior penile implant removed because of infection. The main reason for this dissatisfaction was the loss of penile length from fibrosis. Some evidence suggests that revision surgery permits patients to achieve levels of satisfaction equivalent to first-time surgery rates. This was highlighted in a study comparing satisfaction in 110 patients undergoing a first penile implantation and 39 undergoing reimplantation.35 Seventy-nine percent of patients who underwent first-time implantation and 80% of patients who underwent reimplantation reported satisfactory sexual intercourse, and 73.7% and 70% of patients would undergo the procedure again if the IPP failed, respectively. High patient satisfaction ratings after revision surgery are obtained when precise information related to surgery outcomes and potential complications are discussed with patients before surgery. Thus, previous positive experiences of the prosthesis before device revision was done are sustained.36 The fact that a large proportion of patients with functional penile prosthesis devices reported they would undergo the same surgery again if necessary supports this idea. Moreover, it is hardly surprising to note that removal of the prosthesis without replacement leads to poor satisfaction scores.37
Penile Prosthesis Surgery vs Other Medical Treatments Medical treatments are often used before penile prosthesis implantation is considered. Some studies have explored the difference in satisfaction between penile prosthesis implantation Sex Med Rev 2017;-:1e8
and other ED treatments. One such study compared satisfaction rates of patients treated with oral sildenafil, intracavernous prostaglandin E1, and IPP implantation. Patients managed with the IPP had previously failed sildenafil therapy and had a significantly higher (P < .001) mean EDITS score (82.03 ± 14.41) than patients treated only with sildenafil (61.51 ± 15.98) or intracavernous injection (58.16 ± 18.25) at a follow-up of 20 months.38 In another study, implantation of a penile prosthesis in a small number of patients without prior ED treatment also led to high EDITS and IIEF satisfaction domain scores but not the highest compared with non-surgical ED treatment.39 The main causes of dissatisfaction were technical errors, pain, or psychological problems. Satisfaction ratings were obtained in patients who at 6 months after nerve-sparing radical prostatectomy (RP) received oral tadalafil or penile prosthesis devices. None of these patients had previously used phosphodiesterase type 5 inhibitors. They were evaluated using three domains of the IIEF (erectile function, intercourse satisfaction, and overall satisfaction). Preoperative and postoperative (6 months) IIEF scores were not different between the tadalafil and penile prosthesis groups but became significantly higher (P < .001) in the penile prosthesis group at 12, 18, and 24 months.40 Interpretation of these three studies comparing penile prosthesis implantation with medical therapies is problematic. Patients who have undergone penile prosthesis implantation likely represent a more severe extent of ED compared with that of those actively undergoing medical management. However, in two of these studies, pre-therapeutic erectile function was not mentioned but patients received different treatments with varying efficacies (ranging from vacuum therapy to penile prosthesis) based on patients’ choice. Thus, patients might not have equivalent erectile function at baseline, which is problematic and does not allow comparison between groups. Conversely, the use of ED drug therapy before penile prosthesis implantation could influence patient satisfaction.
Comorbidities Comorbidity status could be relevant in understanding satisfaction outcomes after penile prosthesis surgery. The review of this topic suggests several categories of interest, which include Peyronie disease (PD), prior RP, body mass index higher than 30 kg/m2, and age older than 70 years. PD is a major comorbidity that is considered by some to be associated with dissatisfaction after penile prosthesis surgery. PD often features complex deformities that can influence postoperative expectations and decrease satisfaction after penile prosthesis surgery.41 In one study, dissatisfaction after surgery was associated with various complaints such as decreased penile dimensions, decreased penile sensitivity, and persistent penile deviation.42 However, in this study, patients were managed exclusively with semirigid prosthesis devices, which can be a confounding factor because of the association of these devices
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with a lower satisfaction level. In contrast, the implantation of a three-piece IPP with the addition of penile modeling for PD appears to provide a high level of satisfaction in the same order of magnitude as seen with penile implant surgeries without penile deformities.43,44 Similarly, three-piece IPP with synchronous penile plication or tunica albuginea incision leads to excellent satisfaction rates based on overall satisfaction measurement or IIEF score.45,46 Interestingly, similar good results for patient overall satisfaction were reported with semirigid soft penile prosthesis devices in two studies.47,48 However, the assessment of overall satisfaction was performed using an overall single question, which does not confer the precision of a validated questionnaire. Data are lacking to affirm whether PD leads to a lower satisfaction level, and PD is sometimes an exclusion criterion in studies assessing satisfaction after penile prosthesis implantation. Setting proper postoperative expectations seems to be particularly advantageous for this group of patients to optimize postoperative satisfaction level.49,50 Prior RP also has been proposed to be a factor negatively influencing satisfaction after penile prosthesis surgery. In one study analyzing several comorbidities, EDITS score assessed at least 6 months postoperatively was statistically lower in the RP group compared with the general implant population.51 Major comorbidities occurring in the “general” group included hypertension, dyslipidemia, vascular disease, and diabetes. A consideration for patients with RP, which could contribute to dissatisfaction after penile prosthesis implantation, is that 40% to 70% of patients with RP had penile shortening after prostate surgery.52 Even after penile prosthesis surgery, patients with RP reported most frequently a subjective penile length loss (P ¼ .03), which contributed to a significantly lower EDITS score (P ¼ .008).53 Two others studies compared satisfaction after penile prosthesis surgery in patients with RP vs vasculogenic ED. The first study is consistent with the initial findings showing that patients who had undergone RP had a significantly lower (P ¼ .03) EDITS score (58 ± 10 vs 71 ± 8).54 In the second study, the total score of the IIEF questionnaire was significantly lower (P ¼ .005) in patients with RP.55 IIEF satisfaction domain score and the positive response rate to a single satisfaction question were lower in patients with RP. However, these trends were not statistically significant (P ¼ .09 and P ¼ .3 respectively), whereas the IIEF orgasmic function domain score was significantly lower (P < .001) in patients with RP. Compared with the first study, the main difference in patient characteristics is that patients with RP were significantly (P ¼ .001) older than patients with vasculogenic ED. This could skew the comparison between groups and explain the absence of significant differences between patients with RP and those with vasculogenic ED. After RP, patients have a major and abrupt loss of their erectile function and their ejaculation, often considered by patients as orgasm, which likely has a negative psychological impact.56 This could explain why patients with RP have lower satisfaction levels compared with patients who have progressively lost their erectile function because of a chronic
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disease. Psychological counseling can be helpful to deal with this problem in this specific group. Similarly, obesity (body mass index > 30 kg/m2) has been associated with dissatisfaction after penile prosthesis surgery. This also has been shown through lower EDITS scores in this group compared with the general population.51 Some data indicate that obese patients have a higher risk for ED than those with a normal body mass index (25 kg/m2) because of abnormal endothelial function and psychological factors.57,58 Such factors could contribute to impairments in sexual QoL.59 Thus, obese patients might harbor lower satisfaction at baseline before penile implantation that could explain lower postoperative satisfaction. Management of ED in the aging population (>70 years) can be challenging.60 On the one hand, certain comorbidities observed in older individuals such as coronary artery disease medicated with nitrates might contraindicate some conservative medical therapies for ED (eg, phosphodiesterase type 5 inhibitors). On the other hand, decreased dexterity with aging could confound the operation of an IPP pump. Although difficulty in manipulating the device might lead to lower satisfaction in older men, this belief is not affirmed. In fact, a satisfaction assessment specifically in patients older than 70 years showed excellent results with a mean EDITS score of 75.20.61 Similarly, using a scale from 1 to 5 (with 5 meaning very satisfied), 32 of 35 patients 71 to 86 years of age rated their overall satisfaction as at least 3 (average score ¼ 4.3).62 In another study comparing satisfaction with IPP surgery between men younger and older than 75 years, no difference was found between these two groups.63 On a scale exploring overall satisfaction ranging from 1 to 5, with 5 meaning very satisfied, 90% and 93% of patients, respectively, scored at least 4. Question 1 of the EDITS score also was used and produced comparable results. In addition, in another scale ranging from 1 to 5, with 5 meaning very easy to use, 93% of patients older than 75 years scored 4 or 5. Device improvements, particularly with respect to features of the pump, could be associated with increasingly observed ease of use.64 Review of these data does not support the fact that older patients are more prone to dissatisfaction after surgery. After cognitive and motor performance evaluation in older men with ED, penile prosthesis implantation, including IPP devices, should be included in the therapeutic arsenal. Although satisfaction assessments after penile prosthesis surgery in older patients and those with PD are divergent, obese patients and those after RP might be predisposed toward dissatisfaction as a result of their preoperative sexual dysfunction status and distress concerning their overall adverse health conditions and management.
Influence of the Partner on Patient Satisfaction ED is a couple’s issue in regard to management of the problem and assessment of satisfaction after treatment. Of 69 couples who were evaluated at least 1 year after primary penile prosthesis surgery, mean EDITS scores were 75.48 ± 20.54 Sex Med Rev 2017;-:1e8
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Table 1. Patient satisfaction with penile prosthesis surgery according to several factors Conditions
Main findings
Characteristics of penile prosthesis devices
Among all devices, 3-piece IPPs are the most frequently implanted in the United States and have the highest satisfaction rating.15,18 No significant differences in satisfaction ratings are apparent across IPP brands.16 Patient satisfaction evolves over time. EDITS scores are statistically higher at 12 mo than at 3 or 6 mo after surgery.24,25 With the exception of patients with new implants inserted into fibrotic corporal bodies, revision surgery does not significantly affect patient satisfaction provided precise preoperative information on the surgery and potential complications are provided to the patient. The loss of penile length from fibrosis is the main reason for dissatisfaction.34 IPP leads to higher IIEF scores than tadalafil after RP.40
Revision surgery
Penile prosthesis surgery vs other medical treatment
Comorbidities
Partner profile
Unless equivalent pre-therapeutic erectile function of patients is documented, interpretation of data is problematic. Analysis of the literature shows that patients with RP and obese patients tend to be less satisfied after the surgery because of their preoperative status.51,54 However, there is no evidence to support dissatisfaction in old patients and those with PD.45,46 The partner can influence patient satisfaction and should be included in the assessment.8,67 A correlation of EDITS scores exists between patients and partners.65 Patient satisfaction also is correlated with partner’s FSFI score.66
EDITS ¼ Erectile Dysfunction Inventory of Treatment Satisfaction; FSFI ¼ Female Sexual Function Index; IIEF ¼ International Index of Erectile Function; IPP ¼ inflatable penile prosthesis; PD ¼ Peyronie’s disease; RP ¼ radical prostatectomy.
and 70.00 ± 22.92 in patients and partners, respectively.65 This analysis showed a linear correlation between the degrees of satisfaction for patients and partners except in married couples, in which female satisfaction was lower. A possible reason for this finding, invoked by the investigators, is the possibly lower sexual interest of married couples amid the routine of sexual activity associated with organic changes in women during aging. A different study correlated patient satisfaction with female sexual function through a telephone survey.66 This study involved the Female Sexual Function Index (FSFI), which is a 19-item validated scale used to assess key dimensions of sexual function (desire, arousal, lubrication, orgasm, satisfaction, and pain).67 The analysis suggested a direct correlation between the patient’s degree of satisfaction and FSFI scores. In particular, unsatisfied patients are more likely to have partners with sexual dysfunction. However, it can be questioned whether being unsatisfied with a penile prosthesis, for whatever reason, could be the cause of female sexual dysfunction reflected by the FSFI score. In any case, these findings suggest the importance of considering the partner in the management and follow-up of patients after penile prosthesis surgery.
DISCUSSION Satisfaction is understood to be a major factor in assessing outcomes of penile prosthesis surgery, although this review of the current literature has suggested that the rigor of this assessment is limited. Studies dealing with satisfaction after penile prosthesis surgery emphasize relevant considerations but use a wide heterogeneity of methods in making this assessment. Sex Med Rev 2017;-:1e8
The assessment of satisfaction among these studies highlights potential factors that could determine patient satisfaction, such as device type, ED etiology, and partner profile (Table 1). IPP devices seem to provide a better level of satisfaction than semirigid prosthesis devices without a negative effect from revision surgery. In addition, results were comparable irrespective of the device brand.68,69 In addition, it was interesting to note that obesity and history of RP can be linked with lower satisfaction levels. Conversely, there is no evidence to support the notion that patients with PD and aging patients are at risk for dissatisfaction after penile prosthesis surgery. Despite these findings, the wide variety of satisfaction assessments and the fact that only 43.8% of studies in our review used a validated questionnaire merit some commentary. In a previous review of nine articles on satisfaction, only one study used a validated questionnaire to assess satisfaction.70 The fact is that the EDITS and IIEF questionnaires were developed for the evaluation of patients with ED undergoing medical treatments and at least two questions of the EDITS are inappropriate to assess satisfaction in patients with penile prosthesis devices. Questions 5 and 6 illustrate this perfectly: “During the past 4 weeks, how satisfied have you been with how quickly the treatment works?” and “During the past 4 weeks, how satisfied have you been with how long the treatment lasts?” It would be difficult for patients with penile prosthesis to answer these questions. In fact, they control the onset and the duration of their erection through the mechanical operation of their devices. Similarly, the TSS, which includes a module evaluating the quality of ejaculation, would not be applicable for patients with RP. Conversely, the question of whether a patient would recommend the treatment to a friend was
6
not selected by experts in the EDITS study because it was considered not important in the domain of satisfaction. This question could be judged irrelevant for a medical treatment but might have more importance for an irreversible intervention such as penile prosthesis surgery.71 More than 15 years after the development of the EDITS and IIEF questionnaires, this exercise suggests that it might be time to revise our tools and develop a new validated scale with Likert items that will be most applicable to this field. This sort of evaluation should include such important aspects of satisfaction with penile prosthesis as device operability, natural sensibility before and during intercourse, and orgasm achievement. This new tool also should assess specific fields of partner satisfaction such as responsiveness to the device in particular during intercourse. The development of this new questionnaire will need to involve direct input from patients. For this purpose, focus groups with patients and physicians could be beneficial. This interaction between participants could lead to a candid discussion that is omitted in conventional conditions.72 Moreover, because satisfaction with penile prosthesis surgery is a dynamic process evolving over time, assessments should be done at specific times before and after surgery. For this purpose, the assessment of patient satisfaction must be standardized. This standardization also includes patient assessment under the same conditions. Indeed, in some studies satisfaction was assessed by a telephonic survey conducted by an independent interviewer to decrease bias, whereas other studies completed this evaluation during a medical follow-up appointment in the presence of the surgeon who performed the implantation. It is apparent that answers can be different according to the way in which the data are gathered.
CONCLUSION In this review, we showed that satisfaction is a meaningful end point for reporting outcomes of penile prosthesis surgery. Although satisfaction with penile prosthesis surgery has been studied previously, the assessment has not been vigorous. Indeed, tools that have been used are not specific to assess satisfaction after penile prosthesis surgery. Satisfaction parameters in patients treated for ED medically cannot be transferred to patients treated with a penile prosthesis. The current assessment of satisfaction with the penile prosthesis has suggested potential determinants of satisfaction for this treatment, but this remains inadequate to determine the level of satisfaction accurately and comprehensively. New satisfaction assessment tools specifically designed to evaluate the impact of penile prosthesis surgery should be developed and take into account key parameters that can influence results. Corresponding Author: Arthur L. Burnett, MD, MBA, The James Buchanan Brady Urological Institute and Department of Urology, The Johns Hopkins School of Medicine, 601 North Caroline Street, Baltimore, MD 21205, USA. Tel: þ1-410-6143986; Fax: þ1-410-614-3695; E-mail: [email protected]
Akakpo et al
Conflicts of Interest: Dr Burnett received research support from Boston Scientific (American Medical System). Funding: None.
STATEMENT OF AUTHORSHIP Category 1 (a) Conception and Design William Akakpo; Miguel A. Pineda; Arthur L. Burnett (b) Acquisition of Data William Akakpo; Miguel A. Pineda; Arthur L. Burnett (c) Analysis and Interpretation of Data William Akakpo; Miguel A. Pineda; Arthur L. Burnett Category 2 (a) Drafting the Article William Akakpo; Miguel A. Pineda; Arthur L. Burnett (b) Revising It for Intellectual Content William Akakpo; Miguel A. Pineda; Arthur L. Burnett Category 3 (a) Final Approval of the Completed Article William Akakpo; Miguel A. Pineda; Arthur L. Burnett
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