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# Satisfaction assessment with malleable prosthetic implant of Spectra (AMS) and Genesis (Coloplast) models

## Abstract

The malleable prosthetic implant is widely accepted among patients and physicians owing to a lower degree of surgical complexity, its rare mechanic failures and lower cost. We have compared the degree of satisfaction with malleable prosthetic implant in 60 patients, 36 with Spectra (AMS) and 24 with Genesis (Coloplast). For assessment purposes, we implemented the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) satisfaction questionnaire adapted for penile prosthetic implants. The mean age and follow-up was 61.7 years (31–82) and 19.9 months (1–61), respectively. Mean EDITS scores did not indicate superiority of one implant over the other, overall satisfaction index being 77.1% and 75.6% for Genesis and Spectra prosthesis, respectively (P=0.4970). Our results revealed that these two models of malleable prostheses present a high level of satisfaction and confirm that the malleable prosthetic implant is an excellent option to treat patients with ED refractory to medical treatment.

## Introduction

The penile prosthetic implant is the gold standard for patients with organic ED who are refractory to or dissatisfied with available medical or mechanical therapeutic alternatives or with contraindications to them.1

There are two types of penile prostheses: non-inflatable and inflatable types; the latter is generally associated with higher patient and partner satisfaction rates.2

However, malleable prostheses are widely accepted by physicians and patients because the surgical procedure is less complex, mechanical failure is infrequent and they are less costly.

In general terms, satisfaction with prosthetic implants is high. Many studies prove so as they outrun other effective therapeutic alternatives, such as treatment with PDE5 inhibitors or intracavernous injections.3

Although the global market is dominated by three-piece hydraulic implants, malleable prostheses can be of choice in some medical situations (poor hand dexterity, posttrauma difficult pelvis, neobladders, prior bilateral hernia surgery) and in patients with serious fibrosis in the corpus cavernosum, complex anatomies or as part of a postinfection salvage surgery.4

Non-inflatable penile prostheses may be referred to as semirigid rod or malleable prostheses.

They consist of a pair of spiral wire core with a silicon or polyurethane jacket, but there are models such as the AMS Spectra that were categorized as mechanical devices once; instead of a wire, they have articulated segments (balls and socket joints) of polyethylene that can be held together by a central spring. This design provides positional memory, allowing the prosthesis to remain concealed when not in use, yet rigid during intercourse.

The Genesis’ hydrophilic coating, no springs, cables or moving internal parts to compromise reliability and distal shaft column strength helps prevent buckling, positionability virtually eliminates springback and trimmable—custom fit to each individual. The Coloplast Genesis also has a hydrophilic coating that allows the surgeon to maintain the device preparation with their own antibiotic5 (Figure 1).

Malleable prostheses can be approached in different surgical ways: subcoronal, mid-penile, penoscrotal, and, exceptionally infrapubic or perineal. It is usually carried out under local anesthesia and, in general, it is an outpatient procedure. Its simple technique can be quickly learned.6

A disadvantage that should be considered when discussing malleable prostheses is the permanent rigidity achieved that makes it difficult for any kind of endoscopic maneuver for treating and diagnosing different pathologies of the urinary tract (superficial bladder cancer, BPH, reno-urethral lithiasis and so on).5, 7

It is not easy to assess the satisfaction of patients with penile prostheses. Patients’ subjectivity makes it difficult to analyze it. Moreover, there are no patients who have had the chance of trying different prosthetic devices so as to better assess which one meets their expectations.

Patient satisfaction can be affected by many parameters, including patient expectations, partners’ attitudes, the presence or absence of surgical complications and premature device failures.8

With these limitations in mind, our goal was to compare which of the malleable prostheses made in the United States of America and marketed in our country (AMS Spectra and Coloplast Genesis) turned out to be the one that offered the most satisfaction and comfort to the patient who had undergone implant surgery.

According to our research, when this paper was being developed, there was no publication that compared overall satisfaction in relation to both prosthetic models.

Implantation of malleable prosthesis is usually more frequently suggested in developing countries and it demands less surgical training to implant it. Therefore, we thought that it was important to evaluate patients’ satisfaction results objectively so that urologists can also consider implanting this type of devices. The main aim of this study was to compare the degree of satisfaction in patients with Spectra (AMS) and Genesis (Coloplast) malleable prosthetic implant.

## Material and methods

Between January 2011 and December 2015, 80 patients received a malleable prosthetic implant, 46 of them a Spectra prosthesis and 34 of them Genesis by two surgeons experienced with implantation (ARC and AJB).

All patients underwent preoperative evaluation, including a medical and sexual history, physical examination and hormonal testing, and in all of them, treatment had failed or had been rejected (oral, intracavernous self-injection or vacuum devices).

Satisfaction was measured using the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire adapted to penile prosthetic implant.9, 10 We added to the questionnaire two additional questions on the degree of satisfaction with the penis in resting state and on its malleability.

The choice on the type of prosthesis, Genesis or Spectra, was made by the patient himself. The decision was made by the surgical team only in the cases of Peyronie’s disease with a curvature of >45°.

All of them underwent ambulatory surgery and 47(58.7%) were operated under local anesthesia and were implanted employing a subcoronal, mid-penile or penoscrotal approaches indistinctively. The procedure implemented on two patients was a mid-penile/subcoronal approach and a penoscrotal/subcoronal approach to correct serious curvature of the penis secondary to Peyronie’s disease.

### Statistical methods

Statistical methods employed were Mann–Whitney test and Fisher’s exact test (P<0.05).

### Main outcome measure

Patient satisfaction was evaluated using a standardized assessment tool (the modified EDITS questionnaire).

### Scoring procedure

Overall score=mean of all answered items. The mean score is then multiplied by 25.

## Results

Sixty out of the 80 patients who underwent implant surgery completed the satisfaction questionnaire (75%). Twenty (20) patients were excluded: 6 owing to explantation (5 owing to infection and 1 owing to distal perforation), 2 deceased, and 12 owing to failure of follow-up.

The mean age and follow-up of the 60 patients was 61.7 years (31–82) and 19.9 months (range from 1–61), respectively.

We did not find statistically significant differences between length and girth of implant with the two prosthetic models (P<0.05).

Neither did we find statistically significant differences between the ages and the follow-up with the two prosthetic models (Table 1).

All implanted patients presented organic causes for ED (Table 1). Seven (11.6%) out of the 60 patients in this series had to undergo a prosthetic replacement owing to cracking, mechanical failure or infection of other hydraulic or malleable prosthetic models.

Neither did we find statistically significant differences in any of the 11 parameters assessed with the EDITS questionnaire in relation to satisfaction with the implant (Table 2).

The overall satisfaction index was significantly high, 77.1% and 75.6% for Genesis and Spectra prosthesis, respectively (P=0.4970; Table 3).

Question 1 in the EDITS questionnaire revealed that 51 out of the 60 patients (85%) claimed to be very satisfied or satisfied overall with the prosthesis.

The psychosexual impact of the prosthesis seemed to be positive as 42 patients (70%) responded completely or considerably to the question2, to what degree has the prosthesis met your expectations (P=1.000). Furthermore, 56 patients (93%) were somewhat or very confident about engaging in sexual activity (P=1.000; cf. Q.5).

In relation to questions 4 and 8 that evaluate whether it is easy to use the malleable prosthesis and how natural it is to reach position for penetration of the penis, 86% of the patients claimed that handling the prosthesis was very easy or easy with any of the two models (P=0.7290) and 74% answered that the process to reach position for penetration of the penis was very natural or natural regardless of the model in question (P=1.000).

Questions 10 and 11 complement the modified EDITS questionnaire and they assess satisfaction regarding the appearance of the penis while ‘in resting state’ and the malleability of both prosthetic models. We found that 72% answered that they were very satisfied or satisfied with the penis’ appearance while in resting state (P=0.2599) and 78% claimed that they were very satisfied or satisfied with the prostheses’ malleability (P=0.5336).

The discomfort rate was experienced by 19 patients (32%). The most frequent causes were penile shortness in 10 (17%), delayed ejaculation or anorgasmia in 5 (8.5%) and discomfort due to constant penile rigidity in 4 (7%), 2 with Genesis and 2 with Spectra.

## Discussion

Merriam–Webster Dictionary defines satisfaction as the act of providing what is needed or desired: the act of satisfying a need or desire. Thus this paper’s aim was to assess, using an internationally validated questionnaire, this subjective feeling in those who, after going through a sexual disorder that affects self-esteem and romantic and interpersonal relationships, were able to find a solution to meet their expectations by implanting a malleable prosthesis. The Small–Carrion penile prosthesis revolutionized the semirigid/malleable implant and helped usher in the ‘New Era’ of prosthetics, becoming the prototype that all modern-day malleable implants mimic.4 Unfortunately, few articles reported the outcome on malleable penile prosthesis implants. In general terms, it is considered that patients with a malleable prosthesis have a lower sense of satisfaction than those with hydraulic prosthetic implants. Trost et al.11 reviewed urological and non-urological cosmetic surgery literature to identify factors associated with patient satisfaction/dissatisfaction. Factors associated with satisfaction included decreased preoperative expectations, favorable female partner sexual function, body mass index 30 kg m−2 and the absence of Peyronie’s disease or prior prostatectomy.

Carvalheira et al.12 compared the reasons for satisfaction and dissatisfaction with the prosthetic implant in 14 patients who had received malleable prostheses (12 Dura II y 2 Spectra) and 33 patients with different models of three-piece hydraulic implants using a telephone survey with a non-validated questionnaire. The results reveal a high degree of satisfaction with the implants. Most of these satisfaction factors have been reported by men with both malleable and inflatable implants.12

Natali et al.,13 using an assessment methodology with the modified EDITS questionnaire (by Levine et al.10) for AMS Ambicor prosthesis, was able to record a satisfaction rate of 75% with malleable models AMS 600 and 650 with an mean follow-up of 60 months.13

Salama et al.14 experienced 50 implant surgeries with two types of malleable prostheses, the AMS 650 or Acu-form penile prosthesis with 70% patients and 57% partners’ satisfaction rates, respectively.

Also using the EDITS questionnaire for patients with Spectra prosthetic implants and their partners, Falcone et al.15 found a satisfaction rate of 86.4% in patients and 52.6% in their partners.

Our results support the high index of satisfaction found by other authors with an overall satisfaction index of 77.1% and 75.6% for Genesis and Spectra prostheses, respectively. But if we focus specifically on Q:1 ‘Overall, how satisfied are you with the penile prosthesis?’we will see that 85% out of the total number of patients (51/60) claimed to be very satisfied or satisfied. The same happens with Q:2 ‘To what degree has penile prosthesis met you expectations?’: malleable prostheses fully or considerably met the expectations of 70% of the patients who underwent surgery (42/60).

Something to consider when comparing malleable and hydraulic prosthetic models is satisfaction with the quality of rigidity.

Al Ansari et al.16 used an axial rigidometer on 100 patients who had implant surgery with five different models of penile prostheses. Out of them all, 15 patients had malleable prostheses, 9 got Genesis and 6 got Spectra. Just one patient of the Genesis group claimed to be dissatisfied with the postimplant axial rigidity.

In our series, 71% of those who got Genesis implants and 86% of those who got Spectra implants stated that the quality of the rigidity was the same or better than before suffering from ED (P=0.1133).

Another important difference that favors hydraulic prostheses over malleable prostheses is related to the aesthetic factor in terms of appearance and hiding of the penis while in resting state.

However, Falcone et al.15 considered that certain patients prioritize a lower probability of mechanical failure and the simple handling offered by malleable models over cosmetic results that three-piece prosthesis have to offer.

That is why we added two specific questions to the prosthesis-adapted EDITS satisfaction questionnaire. These two questions were about satisfaction regarding the appearance of the penis in resting state and its malleability.

We found no difference between the two prosthetic models when we assessed these two parameters (Q: 10 and 11). Overall satisfaction in relation to the penis’s appearance in resting state was 72% (43/60) and satisfaction regarding malleability was 78% (47/60).

There is a question that we should ask ourselves when we evaluate prosthetic satisfaction and that is how much time it is reasonable to wait after the implant has been placed to conduct a satisfaction evaluation.

Mulhall et al.17 consider that all variables, including erection, ejaculation, orgasm and overall sexual satisfaction, improved above baseline values at 1 year after surgery and that early assessment, before 3 months, show less satisfactory results suggesting that advice and instructions for use, after surgery, are important to obtain maximum satisfaction and that best results are found between 9 and 12 months.

Falcone et al.,15 while evaluating Spectra prostheses after 3, 6 and 12 months after surgery, proved that, as time goes by, both patients’ and their partners’ satisfaction goes in crescendo.

Yet, in our group—where the mean follow-up time was 19.9 months—we found no difference regarding the extent of satisfaction when we assessed patients before of after 9 months after surgery, with rates of 80% and 75%, respectively (P<0.05).

According to the patients’ perspective, 78% of partners were satisfied with the implant. However, partners of patients who had the Genesis model were more predisposed to accept that they continued using the prosthesis than partners of group Spectra (71% vs 58%; P=0.0035). It was not possible to speculate as to why this happened.

When Carvalheira et al.12 analyzed dissatisfaction reasons in patients with malleable and hydraulic prostheses, they reported similar results in both groups. The most frequent reasons were unrealistic expectations, decrease of the size of the penis and an artificial or unnatural erection. It is worth mentioning that no patients with malleable prostheses mentioned being unsatisfied with its mechanism to move the penis in flaccid or penetrating position. On the other hand, 18% (6/33) of patients who got hydraulic prostheses were dissatisfied with the difficulty in activating the device.12

Thirty-two (32%) of our implanted patients (19/60) said, in some way, that they were dissatisfied with the implant. Some thought that the penis was smaller than expected (n=10), other 5 felt that there was an unwanted delay in ejaculation time and only 4 were uncomfortable experiencing penile rigidity 24 h a day. However, when they answered the EDITS questionnaire, an overall satisfaction rate of 63% was revealed. This is to say that, although expectations were not fully met, having been able to recover rigidity and penetration capacity somehow minimized their discontent.

We would like to clarify that there is a constraint with this study: the selection used to decide the model of malleable prostheses to be implanted was not randomized. Most patients made their choice on the basis of costs or, in some specific cases, depending on the one covered by their health insurances.

Nevertheless, in three patients with Peyronie’s disease with curvatures of >45°, we opted for the Genesis prosthesis owing to the potential need of modeling maneuvers. Owing to its intricate mechanism, Spectra could potentially get damaged with this sort of maneuvering.

Although it is true that other surgical maneuvers can be implemented to correct residual curvatures, such as plication or sectioning of the plate with or without a graft, the first step to approach a residual curvature is modeling.18

In our country, Genesis prostheses costs $1500 and Spectra$2540. Before choosing the model to implant, all patients had the chance of getting to know, touching and handling the samples of both prosthetic models supplied by the dealer.

The new technology behind both prosthetic models has allowed malleable prostheses to achieve very good axial rigidity while being easily concealable when in resting state. The degree of satisfaction is high, close to hydraulic prosthetic models, allowing patients with more limited economic resources to achieve a definite solution to their ED.

## Conclusion

Satisfaction with Genesis and Spectra prosthetic models, as assessed using the EDITS questionnaire, is high. These results confirm that implanting malleable prostheses is an excellent course of treatment for patients suffering from refractory ED to medical therapy.

## References

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Montorsi F, Adaikan G, Becher E, Giuliano F, Khoury S, Lue TF et al. Summary of the recommendations on sexual dysfunctions in men. J Sex Med 2010; 7: 3572–3588.

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Vitarelli A, Divenuto L, Fortunato F, Falco A, Pagliarulo V, Antonini G et al. Long term patient satisfaction and quality of life with AMS700CX inflatable penile prosthesis. Arch Ital Urol Androl 2013; 85: 133–137.

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Martinez DR, Terlecki R, Brant W . The evolution and utility of the Small-Carrion prosthesis, its impact, and progression to the modern-day malleable penile prosthesis. J Sex Med 2015; 12 (Suppl 7): 423–430.

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## Author information

Authors

### Corresponding author

Correspondence to A R Casabé.

## Ethics declarations

### Competing interests

The authors declare no conflict of interest.

## Rights and permissions

Reprints and Permissions

Casabé, A., Sarotto, N., Gutierrez, C. et al. Satisfaction assessment with malleable prosthetic implant of Spectra (AMS) and Genesis (Coloplast) models. Int J Impot Res 28, 228–233 (2016). https://doi.org/10.1038/ijir.2016.33

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