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ESSM position statements of penile prosthesis.

Daniar Osmonov
MD, PhD, FECSM, Dept. of Urology and Pediatric Urology
University hospital Schleswig-Holstein
Campus Kiel, Germany

Gideon Blecher
Dept. of Urology
The Alfred Hospital, Melbourne, Australia
Monash Health, Melbourne, Australia

Marco Falcone
Dept. of Urology, University of Turin
Città della Salute e della Scienza
Turin, Italy

Armin Soave
Department of Urology
University Medical Center Hamburg-Eppendorf
Hamburg, Germany

Sam Ward
Dept. of Urology
Clinique Saint Jean, Brussels
Medicus Medical Center
Woluwe, Belgium

Introduction

The aim of the current position statements of the European Society for Sexual Medicine (ESSM) on penile prosthesis was to better clarify the multiple aspects of inflatable penile prosthetic (IPP) surgery, offering an evidence-based clinical framework to guide management of erectile dysfunction (ED). Challenging was to summarize the important aspects around the IPP`s with a high relevance to the sexual medicine. Despite several studies exploring IPPs surgery, definite conclusions in certain areas remain difficult to provide due to the following reasons: the heterogeneity of models of IPP implanted as well as the variety of surgical approaches, the lack of well-structured prospective randomized controlled trials, the presence of very few scientifically validated tools to assess both patients’ and partners’ satisfaction rates after PP implantation. Several aspects of this surgery, including patient and partner expectations, the possible influence of patients’ comorbidities and social circumstances on the surgical outcomes and patient and partner satisfaction following the implantation, are rarely investigated.

Evidence Acquisition

We performed MEDLINE and EMBASE searches for peer-reviewed papers using the terms: penile prosthesis, patient and partner expectations, cosmesis, disappointment, dissatisfaction, penile prosthesis, penile implantation, comorbidity, socioeconomic factors, diabetes mellitus, prosthesis, outcome, satisfaction, reservoir, phalloplasty. Studies were included if they were less than 10 years old and had direct relevance to the subject. Due to the limited number of prospective and randomized-controlled (RCT) studies on IPP surgery in male patients with ED, all studies were considered and included. Studies older than 10 years were included only if considered to be of great value to the topic with respect to the quality of the data. Data was catalogued into study type, level of evidence, number of subjects, duration of follow-up, treatment arms and outcomes. Papers were analyzed and results summarized with all recommendations made based upon the available literature.

I. Influence of comorbidities & social circumstances of patients in association with PP

  1. Diabetes Mellitus

Statement #1 suggest optimizing glycemic control in patients with diabetes mellitus prior to penile implant surgery (Level 2; Grade B). Uncontrolled diabetes mellitus is a risk factor for increased infection rates [2]. According to a retrospective review of the American Medical Systems (AMS, Minnetonka, Minnesota, USA) database by Mulcahy and Carson [3], there is an increased infection risk for PP performed in patients with diabetes. Diabetic men had a significantly higher rate of revisions due to infection at 7 years (1.88%) than men without diabetes (1.53%; p=0.005) [3]. In contrast, other studies published in the 90s did not find an increased risk of infection in patients with diabetes. There is conflicting data on optimal hemoglobin A1c (HbA1c) cut-offs, which can help predict the potential increased risk of infection in diabetic patients. In a prospective trial of 90 patients, all infections were found in diabetic patients. There were infections in 31% of the poorly controlled, versus 5% of the adequately controlled diabetic patients. In this study, a HbA1c of 11.5% indicated patients at high risk for infection, thus the Authors proposed this as a cut-off value [4]. On the other hand, another prospective study on 389 patients found that there was no increased infection risk with increased levels of Hb1Ac. In addition, there was no difference neither in the median nor mean level of HbA1c in the infected and non-infected patients, regardless of diabetes [5]. The most recent and currently largest multi-center prospective study by Habous et al. [6], which included 902 penile implant procedures, found significantly higher mean HbA1c levels in patients with implant infection (9.5%) compared to patients without infection (7.8%) (p<0.001). A HbA1c threshold level of 8.5% predicted infection with sensitivity of 80% and specificity of 65%.

  1. Prior solid organ transplantation

Statement #2 suggest that patients with prior solid organ transplantation can be considered for PP implantation (Level 3, Grade C). Small case series including less than 20 patients, published in the 1980s and 1990s, reported controversial findings regarding risk of infection and reoperation in patients with a history of previous solid organ transplantation. Some studies found that patients with prior solid organ transplantation had no infections of implants and no device malfunctioning [7][8][9]. Other studies instead found that the risk of infection and the risk of mechanical failure were increased [10][11][12][13]. A retrospective single-center study showed that the risk of infection after insertion of PP in patients with prior organ transplantation was similar to that in patients without prior organ transplantation (4.3% versus 4.2%). The risk of prosthesis malfunction was higher in transplant patients (8.7% versus 3.6%) [14]. In the most recent single-center study by Sun et al., [15], 26 patients with liver, kidney, heart and combined kidney and pancreas transplantation and 26 controls (patients without prior solid organ transplantation) were compared. The Authors found no differences in reoperation rates between the two groups (both 11.5%) at 30 months follow-up. In addition, there was no difference in reoperation rates between the various types of transplanted organs [15].

  1. HIV

Statement #3 suggest offering PP surgery to patients with ED when indicated regardless of the HIV status (Level 3, Grade C). A retrospective study by Gross et al. [16] including 350 patients across two institutions found no difference in risk of PP infection in HIV negative (3%) versus HIV positive (4%) patients. Similarly, a single-center retrospective study by Daoudzadeh et al. [17] of 221 patients in a single institution found no statistically significant difference in subsequent implant infection between men with HIV (8.3%) and men without HIV (5.7%).

  1. Smoking

Statement #4 suggest that smoking may be associated with an increased risk of revision surgery in patients undergoing PP implantation. We suggest encouraging patients to quit smoking (Level 3, Grade C). A retrospective Veterans’ database analysis on 6,586 patients with PP surgery by Lacy et al. [18] and at least one year of follow-up found that smoking was associated with an increased risk of revision or explant surgery following PPI (hazard ration (HR): 1.17; 95CI: 1.02-1.34). Conversely, another retrospective analysis including 152 patients from Veterans Affairs patients at a teaching institution found no difference in the failure or revision rate according to the smoking status [19].Peripheral Vascular

  1. Disease and Hypertension

Statement #5 suggest that peripheral vascular disease and hypertension may be associated with an increased risk of revision surgery in patients undergoing PP implantation. We suggest improving control of hypertension (Level 3, Grade C). A retrospective Veterans’ database analysis on 6,586 patients by Lacy et al. with PP and at least one year of follow-up found that peripheral vascular disease and hypertension were both associated with an increased risk of revision or explant surgery following PP implantation (peripheral vascular disease: HR: 1.25; 95CI: 1.10-1.41; hypertension: HR 1.27; 95CI: 1.12-1.43), [18].

  1. Spinal Cord Injury

Statement #6 suggest that patients with spinal cord injury may receive PP, provided that bladder emptying is possible and long-term indwelling catheters are avoided (Level 3, Grade C). Overall, patients with spinal cord injury seem to be at increased risk for prosthesis infection, as demonstrated by several retrospective studies published in the 1980s and 1990s [20][21][22][23]. One retrospective study by Jarow, however, did not find an increased risk of PP infection in patients with spinal cord injury [24]. A more recent retrospective study by Zermann et al. [25] on 245 neurologically impaired patients including 197 with spinal cord injuries, found a device infection rate of 5% at a mean follow-up of 7 years. With respect to semi-rigid devices, there was 18% risk of erosion, whereas with 3-piece inflatable devices, there were no erosions.

  1. Age

Statement #7 There is no indication that IPP in patients older than 70 years of age results in poorer satisfaction rates. We suggest offering PP to patients aged ≥ 70 years with ED when indicated (Level 3, Grade 3). A retrospective single center study by Al-Najar et al. [26] found that 83% of patients aged ≥ 70 years were satisfied with a PP, and 73% were regularly using the PP for sexual activity. Similarly, another retrospective study by Chung et al. [27] found that 30 men aged ≥ 75 years reported satisfactory outcome with PP surgery and no difference in device survival and satisfaction rates compared to 186 men aged < 75 years at 38.8 months mean follow-up. Another retrospective single-center study by Kim et al. [28] on 438 patients found that patients’ age (<60y vs ≥60y) was not associated with device survival. A retrospective single-center study by Madbouly et al. [49] on 54 patients aged > 60 years found that the modified frailty index was not associated with adverse outcomes at one-year follow-up.

  1. Obesity

Statement #8 suggest offering PP to obese patients with ED, when indicated (Level 3, Grade C). A retrospective single-center study by Kim et al. [28] on 438 patients found that obesity (Body mass index, BMI, ≥30 vs <30 kg/m2) was not associated with device survival. Evidence regarding PP in obese patients is poor and derives from a single retrospective study.

  1. Urinary incontinence

Statement #9 Simultaneous implantation of IPP and artificial urinary sphincter (AUS) may lead to higher revision rates, and therefore the potential benefit of cost-effectiveness of synchronous surgery should be weighed against the potentially increased risk of revision surgery (Level 3, Grade C). A retrospective study by Patel et al. [29] analyzing 11,531 patients who underwent PP surgery, AUS surgery, or both (n=161) found that those with a dual treatment had a higher likelihood of undergoing revision surgery for PP at one year (odds ratio (OR): 2.08; 95%CI: 1.32-3.27; p<0.01) and at three years (OR: 2.60; 95%CI: 1.69-3.99; p<0.01) follow-up [29]. A retrospective study of 95 patients by Mancini et al. [30], including 33 with synchronous surgery, found that revision rate was not statistically different between single and dual surgery (9% versus 3%, p=0.6). Other retrospective studies with patient numbers lower than 20 found that simultaneous implantation of IPP and AUS is safe and effective [31][32]. A retrospective study by Sundaram et al. [33] on 304 patients with AUS found a higher rate of AUS cuff erosion in patients who also had PP placement (11.6%), when compared to patients that did not undergo simultaneous PP surgery (4.3%, p=0.037).

  1. Peyronie’s disease

Statement #9 suggest that PP surgery is feasible in patients with Peyronie’s disease. We suggest that PP surgery should only be performed in the stable phase of the disease and in patients with ED not responding to medical treatment (Level 3, Grade B). Results from the Prospective Registry of Outcomes with Penile Prosthesis for Erectile Restoration (PROPPER) study by Khera et al. [34] demonstrated that >80% of the 250 patients who received PP surgery for ED and concomitant Peyronie’s disease were satisfied or very satisfied and were regularly using their PP at one year and two-year follow-up. A retrospective single-center study by Chung et al. [35] on 138 patients found similar device survival, patient satisfaction and penile straightening independent of the device used.  Another retrospective single-center study by Chung et al. [36] on 18 patients who underwent PP insertion with synchronous penile plication found improvement in overall condition and penile curvature in all patients after a median follow up of 11 months. A retrospective study by Garaffa et al. [37] showed that 29% of patients with Peyronie’s disease who had been treated with PP implantation required additional intraoperative straightening procedures in order to adequately correct the residual curvature. Levine et al. [38] found that PP surgery with straightening maneuvers in 99 men resulted in satisfaction rates of 84% at mean follow-up of 49 months. Complications included penile shortening in 3%, diminished sensitivity in 2%, difficulty operating the device in 1%, persistent curvature in 4%, superficial wound infection in 1%, and mechanical failure in 7% of patients. Overall, 13% of patients required revision surgery, including 7 replacements of PP due to mechanical failure. In two patients, revision was required due to pump malposition, and two patients underwent corporoplasty for impending distal erosion [38].

II. Female and Male Expectations of IPP Surgery

Statement #10 suggest that surgeons thoroughly discuss expected postoperative outcomes with both partners prior to PP surgery, including possible complications and their management (Level 3, Grade B). Over the last decade only a few papers evaluated female partner satisfaction rates [39][40][41]. With this modest evidence and considering the psychological assessment being used in cosmetic surgery, Trost et. al. (2013) formulated seven characteristics associated with higher rates of postoperative dissatisfaction [42]. The authors combined parameters in the mnemonic “CURSED” (Compulsive, Unrealistic, Revision, Surgeon Shopping, Entitled, Denial, and Psychiatric). Character traits of difficult PP patients include obsessive/compulsive tendencies, unrealistic expectations, those seeking multiple surgical options, feelings of entitlement, patients in denial of their prior erectile/sexual function and current disease status, or those with other psychiatric disorders. They provided this framework to identify and interact with difficult PP patients with the intention of enhancing the surgeon’s ability to establish and strengthen the surgeon-patient relationship, reduce physical, emotional and legal risk, as well as ultimately enhancing patient satisfaction. Perhaps this article is a first step toward breaking one of the many barriers in achieving a best outcome for couples having PP surgery [43]. CURSED assessment of preoperative expectation may assist in identifying high risk patients.

III. Inflatable Penile Implant Satisfaction – The Impact of Length, Girth and Implant Type

Statement #11 Despite heterogeneity in the methods of measurement, it appears that overall Inflatable Penile Implant satisfaction is moderate to high (Level 3, Grade C).

Statement #12 Objective measures and patient perception of penile dimensions should be routinely reported in PP outcomes. In some cases, penile length can be progressively increased by the implant acting as a tissue expander (Level 4, Grade C).

Statement #13 Greater girth expansion may occur with longer PP in-situ time (Level 4, Grade C).

Statement #14 Coloplast Titan® showed slightly better rigidity than the AMS LGX® and CX® devices (Level 3, Grade C). The AMS700CX has demonstrated the best axial rigidity (three-point flex test) in the short phallus, the Coloplast Titan slightly better in the long phallus and in Peyronie’s Disease patients (Level 3, Grade C).

Statement #15 Patients should be thoroughly counselled regarding the characteristics of each device in order to optimize satisfaction (Level 4, Grade 4).

Generally, studies demonstrate moderate to high levels of patient and partner satisfaction. However, it is important to remember that there are multiple aspects of satisfaction such as ease of inflation/deflation, appearance, usage, partner related satisfaction, as well as function, which are not universally included in reports of IPP outcomes. Many studies use validated scoring systems such as Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) or International Index of Erectile Function (IIEF), however, these have not necessarily been developed specifically for the evaluation of penile implant outcomes. Validated scoring systems for PP surgery include the Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) [44][45][46], (Table 1).

IV. Patient Satisfaction Regarding Reservoir Placement of IPP

Statement #17 Ectopic high submuscular (HSM) reservoir placement can be considered as an alternative method of reservoir placement during IPP implantation. (Level 2, Grade C).

Statement #18 Palpability of the HSM reservoir does not seem to be a significant factor with regards to revision surgery (Level 2, Grade C).

Statement #19 Subcutaneous reservoir can be used with caution in very obese patients (Level 2, Grade C).

Evidence

Satisfaction with respect to reservoir placement included the following domains – palpability, pain, general satisfaction, complications, device difficulties and location (Table 2).

V. Sexual Satisfaction Associated with IPPs After Phalloplasty Surgery

Statement #20 There is insufficient data to differentiate between IPP and malleable devices in relation to satisfaction rates (Level 4, Grade C).

Statement #21 There is a need for validated instruments for assessment but in their absence, IIEF and SQOL-Men may be useful. (Level 4, Grade C).

Only 6 studies were suitable for inclusion. There were other studies with significant numbers of PP`s in phalloplasty but many only discussed surgical outcomes, complications and ability for sexual penetration without any satisfaction assessment and therefore were not included in the current manuscript (Table 3).

Conclusions:

A majority of the studies published on IPP deal with clinical or technical aspects of surgery, but not with associated factors, such as the patients’ and partners’ expectations, comorbidities and social profiles. Over the last decades a number of papers have described the expectations of both patients and their partners, the influence of the patients’ comorbidities as well as a variety of social aspects in association with PP. This approach should be highly encouraged and supported by multi-centric prospective RCT.

The main disadvantages of the reviewed publications were the retrospective assessment approach with low numbers of patients, most of them summarizing only single center experience. Larger prospective multicentric epidemiological studies should be initiated and supported by relevant international societies.

The present ESSM position should be recognized as the first attempt to improve the understanding of the current situation around IPPs and to initiate further steps such as a European IPP registry to lay the foundation for future prospective multi-center RCT.

Acknowledgements

we would like to thank the members of the section reconstructive surgery of the ESSM scientific committee and invited experts for the outstanding cooperation contributed to the current ESSM statements.

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