- Email: [email protected]
Comparison of Long-Term Results and Couples’ Satisfaction with Penile Implant Types and Brands: Lessons Learned From 883 Patients With Erectile Dysfunction Who Underwent Penile Prosthesis Implantation
SURGERY
Comparison of Long-Term Results and Couples’ Satisfaction with Penile Implant Types and Brands: Lessons Learned From 883 Patients With Erectile Dysfunction Who Underwent Penile Prosthesis Implantation Selahittin Çayan, MD, FECSM,1 Ramazan As¸cı, MD, FECSM,2 Ozan Efesoy, MD,1 Mustafa Suat Bolat, MD,2 Erdem Akbay, MD,1 and Önder Yaman, MD, FECSM3
ABSTRACT
Introduction: No study has compared surgical outcomes and couples’ satisfaction among the 3 types of implants, with all brands available on the markets. Aims: To compare long-term complications, mechanical reliability, and couples’ satisfaction with penile implant types and brands in patients who underwent penile prosthesis implantation. We also investigated whether there are risk factors that might predict couples’ dissatisfaction. Methods: This retrospective study included 883 patients with erectile dysfunction who underwent penile prosthesis implantation. Of the patients, 349 had malleable penile implant, 26 had 2-piece implants, and 508 had 3-piece implants. Main Outcome Measure: Couples’ satisfaction after surgery was evaluated with the modified Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire. Surgical outcomes, mechanical reliability, and couples’ satisfaction were compared according to type and brand of the penile implants in all patients. Results: The mean age and follow-up period of the patients were 57.74 ± 9.59 years and 67.81 ± 49.11 months, respectively. The couples’ satisfaction rates were significantly higher in the 3-piece implant group than in the malleable group (P < .001), but there was no significant difference between the 2-piece and 3-piece implant groups. There was no difference in terms of couples’ satisfaction according to the brand of the implants. Of the patients who had malleable implants, 27 (7.7%) underwent 3-piece penile prosthesis implantation due to dissatisfaction; however, only 1 (0.2%) of the patients with a 3-piece implant was switched to a malleable implant (P < .001). The highest rate of revision surgery due to penile corporal perforation was in the malleable group (2.6%), whereas the highest rate of revision surgery due to penile implant malfunction occurred in the 3-piece implant group (5.5%) (P ¼ .021 and .001, respectively). To analyze risk factors, using multivariate analysis, presence of complication was the only predictor that might cause couples’ dissatisfaction (P ¼ .003). Conclusions: 3-piece and 2-piece implants have higher couples’ satisfaction rates than the malleable implant. Brands of implants did not have any effect on the couples’ satisfaction. Regarding detail of the complications, the 3-piece implant has a lower rate of penile corporal perforation and a higher rate of penile implant malfunction than the malleable implant. Patients with erectile dysfunction who need a penile implant should be informed about surgical outcomes, brands, and types of penile implants. Prosthesis choice should be customized to individual patient’s expectations/conditions and tailored accordingly. Çayan S, As¸cı R, Efesoy O, et al. Comparison of Long-Term Results and Couples’ Satisfaction with Penile Implant Types and Brands: Lessons Learned From 883 Patients With Erectile Dysfunction Who Underwent Penile Prosthesis Implantation. J Sex Med 2019;16:1092e1099. Copyright 2019, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.
Key Words: Penile Prosthesis Implantation; Surgical Outcomes; Couples’ Satisfaction
Received March 19, 2019. Accepted April 22, 2019. 1
Department of Urology, University of Mersin School of Medicine, Mersin, Turkey;
2
Department of Urology, Ondokuz Mayıs University School of Medicine, Samsun, Turkey;
1092
3
Department of Urology, Ankara University School of Medicine, Ankara, Turkey
Copyright ª 2019, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved. https://doi.org/10.1016/j.jsxm.2019.04.013
J Sex Med 2019;16:1092e1099
1093
Couples’ Satisfaction with Penile Implants
INTRODUCTION
MATERIAL AND METHODS
Penile prosthesis implantation is considered in patients who do not respond to pharmacotherapy (phosphodiesterase type 5 inhibitor, intraurethral, or intracavernosal injection therapies) and vacuum constriction devices or who prefer a permanent solution to their problem.1,2 It has excellent long-term outcomes and remains the gold-standard treatment for men with refractory erectile dysfunction.3e5
This retrospective study was conducted between 2003e2018, over a 15-year period. The study was approved by the Institutional Ethics Committee at the University of Mersin School of Medicine. An inform consent was taken from all patients for the surgical procedures. In addition, the patients also provided consent before the surgery for the future use of their data in research projects. The study included 883 patients with erectile dysfunction who underwent penile prosthesis implantation. All surgical procedures were performed by 3 surgeons (S.Ç., R.A., Ö.Y.) in 3 tertiary university hospitals over the same historical time. When the indication for penile implantation was accepted, all patients were informed about all the implant types and brands. The type of penile implant was chosen jointly by the patient and surgeon together. Approach, type, and brand of the implants were selected according to patients’ choice, socioeconomic and educational situation, and medical condition (for example, presence of neurologic diseases or obesity, ability to inflate/ deflate the 2- and 3- piece devices).
The 2 currently available classes of penile implants include inflatable (2- and 3-piece) and semi-rigid devices (malleable, mechanical, soft flexible). Most patients prefer the 3-piece inflatable devices because of the more “natural” erections obtained. Likewise, 3-piece inflatable devices provide the best rigidity and the best flaccidity, because they will fill every part of the corporal bodies. However, the 2-piece inflatable prosthesis can be a viable option among patients who are deemed at high-risk of complications with reservoir placements. Semirigid devices provide a firm penis, which may be manually placed in an erect or flaccid state and offer the advantage of a feasible implant technique, as well as a simpler use for the patient. However, they have the disadvantage of unnatural erection, reduce concealability, and suboptimal penile length and girth.2,6 Men with erectile dysfunction who have decided on penile implantation surgery should be counseled regarding postoperative expectations.1 Although the return of usable erections is almost always achieved with penile implant, patients may still be unhappy with the procedure, if the outcome has not met their expectations. Optimizing patient satisfaction and outcomes should incorporate considerations for preoperative, intraoperative, and postoperative factors.7 Complications associated with penile implants have been categorized as major and minor or early and late complications, including infectious and non-infectious damage, device malfunction, and patient and partner dissatisfaction.8e11 Few studies have compared complications and couples’ satisfaction for the 2 types of prosthesis (comparison of 2 brands of inflatable implants, malleable vs 3-piece or malleable vs 2-piece).12e15 However, no study has compared surgical outcomes or couples’ satisfaction among the 3 types of implants with all brands available on the market.
Aims We attempted to investigate which type and brand of penile prostheses would be ideal for patients and their partners who need penile implant, by comparing long-term complications, mechanical reliability, and couples’ satisfaction according to penile implant types and brands in patients who underwent penile prosthesis implantation. We also investigated whether any risk factors might predict couples’ dissatisfaction.
J Sex Med 2019;16:1092e1099
Cause of erectile dysfunction was classified as diabetes in 378 (42.8%), vascular diseases in 540 (61.2%), pelvic surgeries in 106 (12%), neurogenic in 21 (2.4%), and Peyronie’s disease in 162 (18.3%). Of the patients, 349 had a malleable penile implant (AMS Spectra [n ¼ 244]; Boston Scientific Corp, Marlborough, MA, USA; and Genesis [n ¼ 105]; Coloplast, Minneapolis, MN, USA), 26 had a 2-piece implant (AMS Ambicor; Boston Scientific Corp), and 508 had 3-piece implant (AMS 700 Ultrex Plus [n ¼ 51], AMS 700 CX Inhibizone [n ¼ 161], AMS 700 LGX [n ¼ 41] ; Boston Scientific Corp; and Titan/OTR [n ¼ 255]; Coloplast). Medical records were retrospectively reviewed to collect the patients’ data. Brands, complications, and mechanical reliability of all implants were recorded. Couples’ satisfaction after surgery was evaluated by the other 2 clinicians (O.Z. and M.S.B.) who did not perform the surgeries. The modified Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire was used to assess couples’ satisfaction.16,17 The modified EDITS questionnaire was administered at or within 12 months of the postoperative period, in most cases through face-to-face interviews. However, in some couples who failed to visit the clinics, follow-up was assessed through telephone interviews at the 1-year postoperative period. In addition to the modified EDITS questionnaire, partner satisfaction was assessed by the partners themselves to confirm patients’ answers to the sixth question of the modified EDITS questionnaire, which assesses the partner’s overall satisfaction. An additional validated questionnaire was not used to specifically assess female partners. Surgical outcomes, mechanical reliability, and couples’ satisfaction were compared according to type and brand of the penile implants in all patients.
1094
Çayan et al
Table 1. Mean age, follow-up period, and etiologic factors according to the 3 groups in all patients
Patient age (y) Mean follow-up (mo) Diabetes Vascular disease Pelvic surgeries Neurologic disorders Peyronie’s disease
Malleable (n ¼ 349)
2-piece (n ¼ 26)
3-piece (n ¼ 508)
58.6 ± 7.9 (range, 29e80) 94.8 ± 57.1 (range, 12e244) 141/349 (40.4%) 205/349 (58.7%) 36/349 (10.3%) 9/349 (2.6%) 67/349 (19.2%)
56.8 ± 10.1 (range, 35e74) 31 ± 12.7 (range, 12e52) 10/26 (38.5%) 14/26 (53.8%) 3/26 (11.5%) 0 4/26 (15.4%)
57.2 ± 10.5 (range, 25e83) 51.2 ± 33.2 (range, 12e204) 227/508 (44.7%) 321/508 (63.2%) 67/508 (13.2%) 12/508 (2.4%) 91/508 (17.9%)
Complications were evaluated using the modified Clavien system.10,11 It includes 7 grades (grades IeV) with 2 subgroups for grades III and IV. Complications occurring within 30 days of surgery were classified as early complications. Complications occurring after 30 days of surgery were classified as late complications.
Surgical Techniques Malleable and 2-piece prostheses were performed via penoscrotal approach in all patients. However, 3-piece prostheses were implanted via a penoscrotal approach in 287 patients and an infrapubic approach in 221 patients.
Statistical Analysis For statistical analysis, SPSS (Statistical Package for the Social Sciences Inc, Chicago, IL, USA) version 20.0 package program was used, and P values <.05 were considered to be statistically significant. Descriptive statistics for continuous variables were expressed and also tabulated as mean ± SD, and for categorical variables as frequencies, and percentages (%). The t-test and Mann-Whitney U test were used to compare mean age, followup period, and etiologic factors between/among the groups. Pearson’s c2 and Fisher’s exact test were used to compare results of the modified EDITS questionnaire and postoperative complications as percentage according to the type and brands of the implants between/among the groups. Risk factors such as patient and partner age, diabetes, neurologic disorders, vascular disease, pelvic surgery, penile disorders, and complications that might predict couples’ dissatisfaction were investigated using multivariate analysis. The odds ratio with 95% CI was used to predict couples’ dissatisfaction.
RESULTS The mean age of the patients was 57.7 ± 9.6 years (range, 25e83), and the mean follow-up period was 67.8 ± 49.1 months (range, 12e244). The mean age of the female partners was 43.3 ± 12.8 years (range, 23e68). As shown in Table 1, there were no significant differences in the mean patient age and etiologic factors for erectile dysfunction (P > .05 for each);
P value .107 <.001 .415 .312 .444 .707 .825
however, the mean follow-up period was different among the 3 groups (P < .001), because of historical time differences in the production of the implants.
Satisfaction Results of the modified EDITS questionnaire according to type of the implants are given in Table 2. The couples’ satisfaction rates were significantly higher in the 3-piece implant group than in the malleable group (P < .001), but no significant difference was observed between the 2-piece and 3-piece implant groups. There were no differences in terms of couples’ satisfaction according to brands of the malleable implants. Of the patients, 99.2% were satisfied or somewhat satisfied with the 3-piece implants; however, 90.3% were satisfied or somewhat satisfied in the malleable group, revealing significant difference between the 2 groups (P < .001). The partner’s dissatisfaction rates were 3.3% with the 3-piece implants, 3.8% with the 2-piece implants, and 11.2% with the malleable implants, revealing significant difference among the 3 groups (P < .001). As shown in Table 3, there were no differences in terms of couples’ satisfaction according to brands of the 3-piece implants (P > .05 for each of the 6 questions). Of the patients who had malleable implant, 27 (7.7%) underwent 3-piece penile prosthesis implantation due to dissatisfaction; however, only 1 (0.2%) of the patients with a 3-piece implant was switched to a malleable implant.
Complications Of the patients, 62 (7%) had postoperative early complications as shown in Table 4. Most of the minor complications were minor as grade I (edema and hematoma without need for special treatment except general therapeutic regimens) and grade II (slight infection requiring special pharmacological treatment) of the modified Clavien scale. There were no significant differences in minor complications among the groups. Reservoir herniation, which was classified as a grade IIIb complication that needs special surgical treatment under general anesthesia, occurred in 2 patients who had previous radical prostatectomy after the 3-piece penile prosthesis implantation. Early revision surgery was performed in 4 patients who underwent malleable penile prosthesis due to early J Sex Med 2019;16:1092e1099
1095
Couples’ Satisfaction with Penile Implants
Table 2. Results of the modified EDITS questionnaire according to the type of penile implants
Overall, how satisfied are you with this treatment? Very satisfied Somewhat satisfied Dissatisfied To what degree has the penile prosthesis met your expectations? Completely Considerably Not at all How likely are you to continue to using the penile prosthesis? Very likely Moderately likely Unlikely How easy was it for you to use your penile prosthesis? Very easy Moderately easy Difficult How confident has the penile prosthesis made you feel about your ability to engage in sexual activity? Very confident Somewhat confident Less confident How satisfied is your partner with this treatment? Very satisfied Somewhat satisfied Dissatisfied
Malleable (%) (n ¼ 349)
2-piece (%) (n ¼ 26)
3-piece (%) n ¼ 508)
247/349 (70.8%) 68/349 (19.5%) 34/349 (9.7%)
22/26 (84.6%) 3/26 (11.5%) 1/26 (3.8%)
462/508 (90.9%) 42/508 (8.3%) 4/508 (0.8 %)
P value <.001*
<.001† 231/349 (66.2%) 77/349 (22.1%) 41/349 (11.7%)
20/26 (76.9%) 5/26 (19.2%) 1/26 (3.8%)
432/508 (85%) 68/508 (13.4%) 8/508 (1.6%) <.001‡
45/349 (12.9%) 136/349 (39%) 168/349 (48.1%)
14/26 (53.8%) 10/26 (38.5%) 2/26 (7.7%)
360/508 (70.9%) 127/508 (25%) 21/508 (4.1%) <.001§
313/349 (89.7%) 30/349 (8.6%) 6/349 (1.7%)
15/26(57.7%) 9/26 (34.6%) 2/26 (7.7%)
342/508 (67.3%) 142/508 (28%) 24/508 (4.7%) <.001k
219/349 (62.8%) 94/349 (26.9%) 36/349 (10.3%)
20/26 (76.9%) 5/26 (19.2%) 1/26 (3.8%)
422/508 (83.1%) 77/508 (15.2%) 9/508 (1.8%) <.001{
214/349 (61.3%) 96/349 (27.5) 39/349 (11.2%)
19/26 (73.1%) 6/26 (23.1%) 1/26 (3.8%)
402/508 (79.1%) 89/508 (17.5%) 17/508 (3.3%)
EDITS ¼ Erectile Dysfunction Inventory of Treatment Satisfaction. *P ¼ .422 for the malleable vs 2-piece; P < .001 for the malleable vs 3-piece; P ¼ .160 for the 2-piece vs 3-piece. † P ¼ .396 for the malleable vs 2-piece; P < .001 for the malleable vs 3-piece; P ¼ .227 for the 2-piece vs 3-piece. ‡ P < .001 for the malleable vs 2-piece; P <0.001 for the malleable vs 3-piece; P ¼ .174 for the 2-piece vs 3-piece. § P < .001 for the malleable vs 2-piece; P < .001 for the malleable vs 3-piece; P ¼ .555 for the 2-piece vs 3-piece. k P ¼ .311 for the malleable vs 2-piece; P < .001 for the malleable vs 3-piece; P ¼ .356 for the 2-piece vs 3-piece. { P ¼ .381 for the malleable vs 2-piece; P < .001 for the malleable vs 3-piece; P ¼ .500 for the 2-piece vs 3-piece.
infection (grade IIIb). In these patients, new penile implants were reinserted after removal of malleable prosthesis and washout. As postoperative late complications, a total of 70 patients (7.9%) underwent revision surgery because of dissatisfaction, perforation, or device malfunction. There were significant differences in terms of revision rate and causes among the groups (Table 5). Of the patients who had a malleable implant, 27 (7.7%) underwent 3-piece penile prosthesis implantation due to dissatisfaction; however, only 1 (0.2%) of the patients with a 3-piece implant was switched to malleable implant (P < .001). The highest rate of revision surgery due to penile corporal perforation was in the malleable group, whereas the highest rate of revision surgery due to penile implant malfunction occurred in the 3-piece implant group (P ¼ .021 and .001, respectively). In addition, penile implant malfunction was due to rupture of the cylinders in 2 (0.6%) patients in the malleable implant group and 4 (0.8%) patients in the 3-piece implant group, pump failure J Sex Med 2019;16:1092e1099
in 1 (3.8%) patient in the 2-piece implant group and 16 (3.1%) patients in the 3-piece implant group, reservoir tear in 5 (1%) patients and blowout in the reservoir to pump tubing in 3 (0.8%) patients in the 3-piece implant group. The rate of and reason for penile implant malfunction such as pump failure (P ¼ .578), reservoir tear (P ¼ .987), blowout in the reservoir to pump tubing (P ¼ .901), and cylinder tear (P ¼ .897) were found to be insignificant among the 3-piece implant subgroups (Table 5). To analyze risk factors, using multivariate analysis, as shown in Table 6, there was no observed predictive effect of risk factors such as patient and partner age, diabetes, neurologic disorders, vascular disease, pelvic surgery, and penile disorders on couples’ dissatisfaction; however, presence of complications was only the predictor that might cause couples’ dissatisfaction (P ¼ .003). In addition, etiologic risk factors did not have any effect on any of the complications.
1096
Çayan et al
Table 3. Results of the modified EDITS questionnaire according to the type and brands of the 3-piece implants
Overall, how satisfied are you with this treatment? Very satisfied Somewhat satisfied Dissatisfied To what degree has the penile prosthesis met your expectations? Completely Considerably Not at all How likely are you to continue to using the penile prosthesis? Very likely Moderately likely Unlikely How easy was it for you to use your penile prosthesis? Very easy Moderately easy Difficult How confident has the penile prosthesis made you feel about your ability to engage in sexual activity? Very confident Somewhat confident Less confident How satisfied is your partner with this treatment? Very satisfied Somewhat satisfied Dissatisfied
AMS 700 Ultrex Plus
AMS 700 CX
AMS 700 LGX
Coloplast Titan Mentor Alpha 1
46/51 (90.2%) 3/51(5.9%) 2/51 (3.9%)
150/161 (93.2%) 11/161 (6.8%) 0/161 (0%)
34/41 (82.9%) 6/41 (14.6%) 1/41 (2.4%)
232/255 (91%) 22/255 (8.6%) 1/255 (0.4%)
P value .060
.059 41/51 (80.4%) 7/51 (13.7%) 3/51 (5.9%)
140/161 (87%) 19/161 (11.8%) 2/161 (1.2%)
32/41 (78%) 7/41 (17.1%) 2/41 (4.9%)
219/255 (85.9%) 35/255 (13.7%) 1/255 (0.4%) .186
35/51 (68.6%) 12/51 (23.5%) 4/51 (7.8%)
123/161 (76.4%) 31/161 (19.3%) 7/161 (4.3%)
31/41 (75.6%) 8/41 (19.5%) 2/41 (4.9%)
171/255 (67.1%) 76/255 (29.8%) 8/255 (3.1%) .154
32/51 (62.7%) 14/51 (27.5%) 5/51 (9.8%)
113/161 (70.2%) 38/161 (23.6%) 10/161 (6.2%)
26/41 (63.4%) 12/41 (29.3%) 3/41 (7.3%)
171/255 (67.1%) 78/255 (30.6%) 6/255 (2.4%) .164
40/51 (78.4%) 9/51 (17.6%) 2/51 (3.9%)
140/161 (87%) 17/161 (10.6%) 4/161 (2.5%)
32/41 (78%) 8/41 (19.5%) 1/41 (2.4%)
210/255 (82.4%) 43/255 (16.9%) 2/255 (0.8%)
36/51 (70.6%) 11/51 (21.6%) 4/51 (7.8%)
134/161 (83.2%) 23/161 (14.3%) 4/161 (2.5%)
31/41 (75.6%) 7/41 (17.1%) 3/41 (7.3%)
201/255 (78.8%) 48/255(18.8%) 6/255(2.4%)
.192
EDITS ¼ Erectile Dysfunction Inventory of Treatment Satisfaction.
In the present study, the patient and partner satisfaction rates were significantly higher in the 3-piece implant group than in the malleable group, but no significant difference between the 2piece and 3-piece implant groups. There were no differences in terms of couples’ satisfaction according to brands of the penile implants. Otero et al12 compared patient and partner satisfaction between AMS 700 CX (Boston Scientific Corp) and Titan in 207 patients who had penile implant. They found that overall satisfaction was very high for both types of prosthesis, but more
DISCUSSION Few studies have compared patient and partner satisfaction for the 2 types of prostheses (comparison of 2 brands of inflatable implants, malleable vs 3-piece or malleable vs 2-piece).12e15 However, no study has compared 3 types of implants with all brands available on the market, and this is the first study to compare couples’ satisfaction in addition to long-term outcome of the implant surgery and predictors of dissatisfaction in the same study.
Table 4. Postoperative early complications, classified according to the modified Clavien system Grade I II IIIa IIIb VIa IVb V
Malleable (n ¼ 349)
2-piece (n ¼ 26)
3-piece (n ¼ 508)
P value
9/349 (2.6%) 6/349 (1.7%)
1/26 (3.8%) 1/26 (3.8%)
28/508 (5.5%) 11/508 (2.2%)
.114 .724
4/349 (1.1%)
0
2/508 (0.4%)
.357
None None None None
J Sex Med 2019;16:1092e1099
1097
Couples’ Satisfaction with Penile Implants
Table 5. Postoperative late complications, classified according to the modified Clavien system Causes of revision surgery
Malleable (n ¼ 349)
2-piece (n ¼ 26)
3-piece (n ¼ 508)
P value
Dissatisfaction with implant Penile corporal perforation Penile implant malfunction
27/349 (7.7%) 9/349 (2.6%) 2/349 (0.6%)
0 0 1/26 (3.8%)
1/508 (0.2%) 2/508 (0.4%) 28/508 (5.5%)
<.001 .021 .001
patients were satisfied with the AMS 700 CX. Kılıçarslan et al13 included 46 patients who underwent AMS 600/650 (Boston Scientific Corp) or AMS Ambicor prosthesis implantation. They reported higher satisfaction rates with the 2-piece inflatable prostheses when compared with malleable prostheses. Morgado et al14 compared overall patient satisfaction in 55 patients, using the EDITS questionnaire. They found no significant difference in EDITS score between the AMS 700 CX and Titan.14 The short-term satisfaction rate in 142 patients treated with penile implants has been reported, using the validated quality of life and sexuality with penile prosthesis questionnaire.15 They found high functional and patient satisfaction scores at 1 year after penile prosthesis surgery. Barton et al16 published a comprehensive review of available literature regarding sexual quality of life and satisfaction with penile prostheses. They reported patient satisfaction rates with penile prostheses as >85%, and sexual quality of life is improved in both patients and their partners. Many predictive factors, including patient age; type and brand of implant; obesity; systemic vascular comorbidities such as diabetes, hypertension, dyslipidemia, and thyroid disease; abdominal and pelvic surgeries for cancer or anatomic problems; Peyronie’s disease; and surgical complications related to penile implant surgery have been investigated for the patient and partner satisfaction in the published series.6,15,17 Habous et al17 investigated predictors of satisfaction, using a single question and scoring system in men who underwent penile implant surgery. Of the patients, 93% had high satisfaction (score 4). However, they found that patients with a major complication, with or
Table 6. Multivariate analysis of the parameters that might predict couples’ dissatisfaction 95% CI Parameters
P value
OR
Lower
Upper
Patient age Partner age Diabetes Neurologic disorders Vascular disease Pelvic trauma (surgical or external) Peyronie’s disease Complications
.362 .227 .242 .999 .505 .173
1.015 0.911 0.645 0.000 0.753 0.370
0.983 0.784 0.310 0.000 0.327 0.089
1.049 1.059 1.344 — 1.734 1.547
.816 .003
1.105 3.058
0.478 1.457
2.556 6.420
OR ¼ odds ratio. J Sex Med 2019;16:1092e1099
without an additional minor complication, had a higher likelihood of being dissatisfied (25%) compared with patients with no complication (1.9%) or only minor complication (3.7%). The overall satisfaction rate was higher in patients with inflatable implant than with a malleable implant. They suggested that major complications have a major impact on patient satisfaction. However, they did not assess partner satisfaction in their studies. Capogrosso et al15 found no association between erectile dysfunction etiology and patient satisfaction scores. However, they reported that surgeon experience emerged as the only independent predictor of higher satisfaction scores. However, they did not assess partner satisfaction in their studies. In the present study, the partner’s dissatisfaction rates were 3.3% in the 3-piece implants, 3.8% in the 2-piece implants, and 11.2% in the malleable implants, revealing significant difference among the 3 groups. When we analyzed risk factors, using multivariate analysis, presence of complication was only predictor that might cause couples’ dissatisfaction. Complications associated with penile implants have been categorized as major and minor or early and late complications, including infectious and non-infectious damage, device malfunction, and patient and partner dissatisfaction.6,8e11 Contemporary series of 3-piece penile prostheses report mechanical survival rates of 81e94%, 68e89%, and 57e76% at 5, 10, and 15 years, respectively. Infection risk varies from 0e25% in the literature, depending on morbidity and presence of revision surgery.18,19 Infection rates of current devices are 1e2% in first-time, low-risk populations, and 2e3% for higher risk groups, with patient and partner satisfaction at 92e100% and 91e95%, respectively. Standardization of surgical technique and improvements in device construction have reduced all-cause complication rates to <5% in recent reports.20,21 2-piece and malleable devices are associated with slightly higher mechanical reliability, but they have decreased patient satisfaction.3 In the present study, 7% had postoperative early complications, and there were no significant differences in minor complications among the groups. As postoperative late complications, 7.9% underwent revision surgery due to dissatisfaction, perforation, and device malfunction. There were significant differences in terms of revision rate and causes among the groups. Of the patients who had malleable implants, 27 (7.7%) underwent 3-piece penile prosthesis implantation due to dissatisfaction; however, only 1 (0.2%) of the patients with a 3-piece implant was switched to a malleable implant. The highest rate of revision surgery due to penile corporal perforation was in the malleable
1098
group (2.6%), whereas the highest rate of revision surgery due to penile implant malfunction occurred in the 3-piece implant group (5.5%).
Limitations Despite the important of the findings related to comparison of long-term complications, mechanical reliability and couples’ satisfaction according to penile implant types and brands in patients who underwent penile prosthesis implantation, our study has some limitations. Many studies have examined the effect of penile implants on patient or partner satisfaction, mostly using International Index of Erectile Function (IIEF) and EDITS questionnaires.16,22e24 Akakpo et al25 reviewed 48 articles examining patient satisfaction with penile prostheses and found that 66.2% of the articles reviewed used non-validated questionnaires in assessing satisfaction. Other rarely used tools include the Sexual Life Quality Questionnaire, Sexual Experience Questionnaire, Self-Esteem and Relationship Questionnaire, and Quality of Life and Sexuality with Penile Prosthesis.25 Therefore, in the present study, we used modified EDITS questionnaire, which is mostly used in the studies, although it is non-validated instrument with sub-optimally measurement of satisfaction. In addition to the modified EDITS questionnaire, preimplantation and postimplantation IIEF questionnaires have been used, and partner satisfaction has been specifically assessed in some studies. Vakalopoulos et al17 evaluated patients’ erectile function and couples’ satisfaction after 3-piece penile prosthesis implantation, and they found the mean IIEF score significantly increased after surgery, with high rates of patient and partner satisfaction. In their study, patient satisfaction appeared independent of prosthesis type and cylinder length. In our study, we did not include an IIEF questionnaire to assess postoperative erectile function with the implant, and an additional validated questionnaire was not used to specifically assess female partners.
CONCLUSION Overall, all types and brands of penile implants have high level of treatment success, mechanical reliability, and couples’ satisfaction with very low complication rates. But 3-piece and 2-piece implants have higher couple satisfaction rates than malleable implant. Brands of the implants did not have any effect on the couples’ satisfaction. Regarding detail of the complications, the 3-piece implant has a lower rate of penile corporal perforation and a higher rate of penile implant malfunction than the malleable implant. Patients with erectile dysfunction who need a penile implant should be informed about surgical outcomes, brands, and types of penile implants. Prosthesis choice should be customized to individual patient’s expectations/conditions and tailored accordingly. Corresponding Author: Selahittin Çayan, MD, FECSM, University of Mersin School of Medicine, Department of
Çayan et al
Urology, 33079 Mersin, Turkey. Tel: þ90 532 346 0509; Fax: þ90 324 337 3738; E-mail: [email protected] Conflicts of Interest: The authors report no conflicts of interest. Funding: None.
STATEMENT OF AUTHORSHIP Category 1 (a) Conception and Design Selahittin Çayan; Ozan Efesoy; Ramazan As¸cı; Önder Yaman (b) Acquisition of Data Selahittin Çayan; Ozan Efesoy; Ramazan As¸cı; Mustafa Suat Bolat; Erdem Akbay; Önder Yaman (c) Analysis and Interpretation of Data Selahittin Çayan; Ozan Efesoy; Erdem Akbay Category 2 (a) Drafting the Article Selahittin Çayan; Ramazan As¸cı; Önder Yaman (b) Revising It for Intellectual Content Selahittin Çayan; Ramazan As¸cı; Önder Yaman Category 3 (a) Final Approval of the Completed Article Selahittin Çayan; Ramazan As¸cı; Önder Yaman
REFERENCES 1. Burnett A, Nehra A, Breau RH, et al. Erectile Dysfunction: AUA guideline. J Urol 2018;200:633-641. 2. Hatzimouratidis K, Giuliano F, Moncada I, et al. EAU guidelines on male sexual dysfunction. Arnhem, The Netherlands: EAU Guidelines Office; 2018. 3. Trost L, Hellstrom WJ. History, contemporary outcomes, and future of penile prostheses: A review of the literature. Sex Med Rev 2013;1:150-163. 4. Trost L, McCaslin R, Linder B, et al. Long-term outcomes of penile prostheses for the treatment of erectile dysfunction. Expert Rev Med Devices 2013;10:353-366. 5. Hellstrom WJ, Montague DK, Moncada I, et al. Implants, mechanical devices, and vascular surgery for erectile dysfunction. J Sex Med 2010;7(part 2):501-523. 6. Levine LA, Becher E, Bella A, et al. Current recommendations from the International Consultation on Sexual Medicine. J Sex Med 2016;13:489-518. 7. Welliver C. Optimizing outcomes in the virgin penile ımplant patient. Curr Urol Rep 2019;20:14. 8. Krzastek SC, Smith R. An update on the best approaches to prevent complications in penile prosthesis recipients. Ther Adv Urol 2019;11:1-9. 9. O’Rourke TK Jr, Erbella A, Zhang Y, et al. Prevention, identification, and management of post-operative penile implant complications of infection, hematoma, and device malfunction. Transl Androl Urol 2017;6(Suppl. 5):S832-S848. 10. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: A new proposal with evaluation in a cohort of J Sex Med 2019;16:1092e1099
Couples’ Satisfaction with Penile Implants
1099
6336 patients and results of a survey. Ann Surg 2004; 240:205-213.
prosthesis implants: Up to 7.7 years of follow-up. J Urol 2011; 185:614-618.
11. Vakalopoulos I, Kampantais S, Gkagkalidis K, et al. Complications of inflatable penile prostheses implantation classified according to the modified Clavien system. Adv AndrolVolume 2014; Article ID 127693, 5 page.
19. Montgomery BD, Lomas DJ, Ziegelmann MJ, et al. Infection risk of undergoing multiple penile prostheses: An analysis of referred patient surgical histories. Int J Impot Res 2018; 30:147-152.
12. Otero JR, Cruz CR, Gomez BG, et al. Comparison of the patient and partner satisfaction with 700CX and Titan penile prostheses. Asian J Androl 2017;19:321-325. 13. Kılıçarslan H, Kaynak Y, Gökçen K, et al. Comparison of patient satisfaction rates for the malleable and two-piece-inflatable penile prostheses. Turk J Urol 2014;40:207-210. 14. Morgado A, Cavadas AS, Pacheco Figueiredo L, et al. Longterm patient-reported satisfaction with different inflatable penile prosthesis: Comparison between AMS 700CX and Coloplast Titan. Rev Int Androl 2018;16(3):112-118. 15. Capogrosso P, Pescatori E, Caraceni E, et al. Satisfaction rate at 1-year follow-up in patients treated with penile implants: Data from the multicenter prospective registry INSIST-ED. BJU Int 2019;123:360-366. 16. Barton GJ, Carlos EC, Lentz AC. Sexual quality of life and satisfaction with penile prostheses. Sex Med Rev 2019;7: 178-188. 17. Habous M, Tal R, Tealab A, et al. Predictors of satisfaction in men after penile implant surgery. J Sex Med 2018;15: 1180-1186. 18. Carson CC, Mulcahy JJ, Harsch MR. Long-term infection outcomes after original antibiotic impregnated inflatable penile
J Sex Med 2019;16:1092e1099
20. Scherzer ND, Dick B, Gabrielson AT, et al. Penile prosthesis complications: Planning, prevention, and decision making. Sex Med Rev 2019;7:349-359. 21. Eid JF, Wilson SK, Cleves M, et al. Coated implants and “no touch” surgical technique decreases risk of infection in inflatable penile prosthesis implantation to 0.46%. Urology 2012;79:1310-1315. 22. Althof SE, Corty EW, Levine SB, et al. EDITS: Development of questionnaires for evaluating satisfaction with treatments for erectile dysfunction. Urology 1999;53:793-799. 23. Lux M, Reyes-Vallejo L, Morgantaler A, et al. Outcomes and satisfaction rates for the redesigned 2-piece penile prosthesis. J Urol 2007;177:262-266. 24. 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. 25. Akakpo W, Pineda MA, Burnett AL. Critical analysis of satisfaction assessment after penile prosthesis surgery. Sex Med Rev 2017;5:244-251.
Comparison of Long-Term Results and Couples’ Satisfaction with Penile Implant Types and Brands: Lessons Learned From 883 Patients With Erectile Dysfunction Who Underwent Penile Prosthesis Implantation Selahittin Çayan, MD, FECSM,1 Ramazan As¸cı, MD, FECSM,2 Ozan Efesoy, MD,1 Mustafa Suat Bolat, MD,2 Erdem Akbay, MD,1 and Önder Yaman, MD, FECSM3
ABSTRACT
Introduction: No study has compared surgical outcomes and couples’ satisfaction among the 3 types of implants, with all brands available on the markets. Aims: To compare long-term complications, mechanical reliability, and couples’ satisfaction with penile implant types and brands in patients who underwent penile prosthesis implantation. We also investigated whether there are risk factors that might predict couples’ dissatisfaction. Methods: This retrospective study included 883 patients with erectile dysfunction who underwent penile prosthesis implantation. Of the patients, 349 had malleable penile implant, 26 had 2-piece implants, and 508 had 3-piece implants. Main Outcome Measure: Couples’ satisfaction after surgery was evaluated with the modified Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire. Surgical outcomes, mechanical reliability, and couples’ satisfaction were compared according to type and brand of the penile implants in all patients. Results: The mean age and follow-up period of the patients were 57.74 ± 9.59 years and 67.81 ± 49.11 months, respectively. The couples’ satisfaction rates were significantly higher in the 3-piece implant group than in the malleable group (P < .001), but there was no significant difference between the 2-piece and 3-piece implant groups. There was no difference in terms of couples’ satisfaction according to the brand of the implants. Of the patients who had malleable implants, 27 (7.7%) underwent 3-piece penile prosthesis implantation due to dissatisfaction; however, only 1 (0.2%) of the patients with a 3-piece implant was switched to a malleable implant (P < .001). The highest rate of revision surgery due to penile corporal perforation was in the malleable group (2.6%), whereas the highest rate of revision surgery due to penile implant malfunction occurred in the 3-piece implant group (5.5%) (P ¼ .021 and .001, respectively). To analyze risk factors, using multivariate analysis, presence of complication was the only predictor that might cause couples’ dissatisfaction (P ¼ .003). Conclusions: 3-piece and 2-piece implants have higher couples’ satisfaction rates than the malleable implant. Brands of implants did not have any effect on the couples’ satisfaction. Regarding detail of the complications, the 3-piece implant has a lower rate of penile corporal perforation and a higher rate of penile implant malfunction than the malleable implant. Patients with erectile dysfunction who need a penile implant should be informed about surgical outcomes, brands, and types of penile implants. Prosthesis choice should be customized to individual patient’s expectations/conditions and tailored accordingly. Çayan S, As¸cı R, Efesoy O, et al. Comparison of Long-Term Results and Couples’ Satisfaction with Penile Implant Types and Brands: Lessons Learned From 883 Patients With Erectile Dysfunction Who Underwent Penile Prosthesis Implantation. J Sex Med 2019;16:1092e1099. Copyright 2019, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.
Key Words: Penile Prosthesis Implantation; Surgical Outcomes; Couples’ Satisfaction
Received March 19, 2019. Accepted April 22, 2019. 1
Department of Urology, University of Mersin School of Medicine, Mersin, Turkey;
2
Department of Urology, Ondokuz Mayıs University School of Medicine, Samsun, Turkey;
1092
3
Department of Urology, Ankara University School of Medicine, Ankara, Turkey
Copyright ª 2019, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved. https://doi.org/10.1016/j.jsxm.2019.04.013
J Sex Med 2019;16:1092e1099
1093
Couples’ Satisfaction with Penile Implants
INTRODUCTION
MATERIAL AND METHODS
Penile prosthesis implantation is considered in patients who do not respond to pharmacotherapy (phosphodiesterase type 5 inhibitor, intraurethral, or intracavernosal injection therapies) and vacuum constriction devices or who prefer a permanent solution to their problem.1,2 It has excellent long-term outcomes and remains the gold-standard treatment for men with refractory erectile dysfunction.3e5
This retrospective study was conducted between 2003e2018, over a 15-year period. The study was approved by the Institutional Ethics Committee at the University of Mersin School of Medicine. An inform consent was taken from all patients for the surgical procedures. In addition, the patients also provided consent before the surgery for the future use of their data in research projects. The study included 883 patients with erectile dysfunction who underwent penile prosthesis implantation. All surgical procedures were performed by 3 surgeons (S.Ç., R.A., Ö.Y.) in 3 tertiary university hospitals over the same historical time. When the indication for penile implantation was accepted, all patients were informed about all the implant types and brands. The type of penile implant was chosen jointly by the patient and surgeon together. Approach, type, and brand of the implants were selected according to patients’ choice, socioeconomic and educational situation, and medical condition (for example, presence of neurologic diseases or obesity, ability to inflate/ deflate the 2- and 3- piece devices).
The 2 currently available classes of penile implants include inflatable (2- and 3-piece) and semi-rigid devices (malleable, mechanical, soft flexible). Most patients prefer the 3-piece inflatable devices because of the more “natural” erections obtained. Likewise, 3-piece inflatable devices provide the best rigidity and the best flaccidity, because they will fill every part of the corporal bodies. However, the 2-piece inflatable prosthesis can be a viable option among patients who are deemed at high-risk of complications with reservoir placements. Semirigid devices provide a firm penis, which may be manually placed in an erect or flaccid state and offer the advantage of a feasible implant technique, as well as a simpler use for the patient. However, they have the disadvantage of unnatural erection, reduce concealability, and suboptimal penile length and girth.2,6 Men with erectile dysfunction who have decided on penile implantation surgery should be counseled regarding postoperative expectations.1 Although the return of usable erections is almost always achieved with penile implant, patients may still be unhappy with the procedure, if the outcome has not met their expectations. Optimizing patient satisfaction and outcomes should incorporate considerations for preoperative, intraoperative, and postoperative factors.7 Complications associated with penile implants have been categorized as major and minor or early and late complications, including infectious and non-infectious damage, device malfunction, and patient and partner dissatisfaction.8e11 Few studies have compared complications and couples’ satisfaction for the 2 types of prosthesis (comparison of 2 brands of inflatable implants, malleable vs 3-piece or malleable vs 2-piece).12e15 However, no study has compared surgical outcomes or couples’ satisfaction among the 3 types of implants with all brands available on the market.
Aims We attempted to investigate which type and brand of penile prostheses would be ideal for patients and their partners who need penile implant, by comparing long-term complications, mechanical reliability, and couples’ satisfaction according to penile implant types and brands in patients who underwent penile prosthesis implantation. We also investigated whether any risk factors might predict couples’ dissatisfaction.
J Sex Med 2019;16:1092e1099
Cause of erectile dysfunction was classified as diabetes in 378 (42.8%), vascular diseases in 540 (61.2%), pelvic surgeries in 106 (12%), neurogenic in 21 (2.4%), and Peyronie’s disease in 162 (18.3%). Of the patients, 349 had a malleable penile implant (AMS Spectra [n ¼ 244]; Boston Scientific Corp, Marlborough, MA, USA; and Genesis [n ¼ 105]; Coloplast, Minneapolis, MN, USA), 26 had a 2-piece implant (AMS Ambicor; Boston Scientific Corp), and 508 had 3-piece implant (AMS 700 Ultrex Plus [n ¼ 51], AMS 700 CX Inhibizone [n ¼ 161], AMS 700 LGX [n ¼ 41] ; Boston Scientific Corp; and Titan/OTR [n ¼ 255]; Coloplast). Medical records were retrospectively reviewed to collect the patients’ data. Brands, complications, and mechanical reliability of all implants were recorded. Couples’ satisfaction after surgery was evaluated by the other 2 clinicians (O.Z. and M.S.B.) who did not perform the surgeries. The modified Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire was used to assess couples’ satisfaction.16,17 The modified EDITS questionnaire was administered at or within 12 months of the postoperative period, in most cases through face-to-face interviews. However, in some couples who failed to visit the clinics, follow-up was assessed through telephone interviews at the 1-year postoperative period. In addition to the modified EDITS questionnaire, partner satisfaction was assessed by the partners themselves to confirm patients’ answers to the sixth question of the modified EDITS questionnaire, which assesses the partner’s overall satisfaction. An additional validated questionnaire was not used to specifically assess female partners. Surgical outcomes, mechanical reliability, and couples’ satisfaction were compared according to type and brand of the penile implants in all patients.
1094
Çayan et al
Table 1. Mean age, follow-up period, and etiologic factors according to the 3 groups in all patients
Patient age (y) Mean follow-up (mo) Diabetes Vascular disease Pelvic surgeries Neurologic disorders Peyronie’s disease
Malleable (n ¼ 349)
2-piece (n ¼ 26)
3-piece (n ¼ 508)
58.6 ± 7.9 (range, 29e80) 94.8 ± 57.1 (range, 12e244) 141/349 (40.4%) 205/349 (58.7%) 36/349 (10.3%) 9/349 (2.6%) 67/349 (19.2%)
56.8 ± 10.1 (range, 35e74) 31 ± 12.7 (range, 12e52) 10/26 (38.5%) 14/26 (53.8%) 3/26 (11.5%) 0 4/26 (15.4%)
57.2 ± 10.5 (range, 25e83) 51.2 ± 33.2 (range, 12e204) 227/508 (44.7%) 321/508 (63.2%) 67/508 (13.2%) 12/508 (2.4%) 91/508 (17.9%)
Complications were evaluated using the modified Clavien system.10,11 It includes 7 grades (grades IeV) with 2 subgroups for grades III and IV. Complications occurring within 30 days of surgery were classified as early complications. Complications occurring after 30 days of surgery were classified as late complications.
Surgical Techniques Malleable and 2-piece prostheses were performed via penoscrotal approach in all patients. However, 3-piece prostheses were implanted via a penoscrotal approach in 287 patients and an infrapubic approach in 221 patients.
Statistical Analysis For statistical analysis, SPSS (Statistical Package for the Social Sciences Inc, Chicago, IL, USA) version 20.0 package program was used, and P values <.05 were considered to be statistically significant. Descriptive statistics for continuous variables were expressed and also tabulated as mean ± SD, and for categorical variables as frequencies, and percentages (%). The t-test and Mann-Whitney U test were used to compare mean age, followup period, and etiologic factors between/among the groups. Pearson’s c2 and Fisher’s exact test were used to compare results of the modified EDITS questionnaire and postoperative complications as percentage according to the type and brands of the implants between/among the groups. Risk factors such as patient and partner age, diabetes, neurologic disorders, vascular disease, pelvic surgery, penile disorders, and complications that might predict couples’ dissatisfaction were investigated using multivariate analysis. The odds ratio with 95% CI was used to predict couples’ dissatisfaction.
RESULTS The mean age of the patients was 57.7 ± 9.6 years (range, 25e83), and the mean follow-up period was 67.8 ± 49.1 months (range, 12e244). The mean age of the female partners was 43.3 ± 12.8 years (range, 23e68). As shown in Table 1, there were no significant differences in the mean patient age and etiologic factors for erectile dysfunction (P > .05 for each);
P value .107 <.001 .415 .312 .444 .707 .825
however, the mean follow-up period was different among the 3 groups (P < .001), because of historical time differences in the production of the implants.
Satisfaction Results of the modified EDITS questionnaire according to type of the implants are given in Table 2. The couples’ satisfaction rates were significantly higher in the 3-piece implant group than in the malleable group (P < .001), but no significant difference was observed between the 2-piece and 3-piece implant groups. There were no differences in terms of couples’ satisfaction according to brands of the malleable implants. Of the patients, 99.2% were satisfied or somewhat satisfied with the 3-piece implants; however, 90.3% were satisfied or somewhat satisfied in the malleable group, revealing significant difference between the 2 groups (P < .001). The partner’s dissatisfaction rates were 3.3% with the 3-piece implants, 3.8% with the 2-piece implants, and 11.2% with the malleable implants, revealing significant difference among the 3 groups (P < .001). As shown in Table 3, there were no differences in terms of couples’ satisfaction according to brands of the 3-piece implants (P > .05 for each of the 6 questions). Of the patients who had malleable implant, 27 (7.7%) underwent 3-piece penile prosthesis implantation due to dissatisfaction; however, only 1 (0.2%) of the patients with a 3-piece implant was switched to a malleable implant.
Complications Of the patients, 62 (7%) had postoperative early complications as shown in Table 4. Most of the minor complications were minor as grade I (edema and hematoma without need for special treatment except general therapeutic regimens) and grade II (slight infection requiring special pharmacological treatment) of the modified Clavien scale. There were no significant differences in minor complications among the groups. Reservoir herniation, which was classified as a grade IIIb complication that needs special surgical treatment under general anesthesia, occurred in 2 patients who had previous radical prostatectomy after the 3-piece penile prosthesis implantation. Early revision surgery was performed in 4 patients who underwent malleable penile prosthesis due to early J Sex Med 2019;16:1092e1099
1095
Couples’ Satisfaction with Penile Implants
Table 2. Results of the modified EDITS questionnaire according to the type of penile implants
Overall, how satisfied are you with this treatment? Very satisfied Somewhat satisfied Dissatisfied To what degree has the penile prosthesis met your expectations? Completely Considerably Not at all How likely are you to continue to using the penile prosthesis? Very likely Moderately likely Unlikely How easy was it for you to use your penile prosthesis? Very easy Moderately easy Difficult How confident has the penile prosthesis made you feel about your ability to engage in sexual activity? Very confident Somewhat confident Less confident How satisfied is your partner with this treatment? Very satisfied Somewhat satisfied Dissatisfied
Malleable (%) (n ¼ 349)
2-piece (%) (n ¼ 26)
3-piece (%) n ¼ 508)
247/349 (70.8%) 68/349 (19.5%) 34/349 (9.7%)
22/26 (84.6%) 3/26 (11.5%) 1/26 (3.8%)
462/508 (90.9%) 42/508 (8.3%) 4/508 (0.8 %)
P value <.001*
<.001† 231/349 (66.2%) 77/349 (22.1%) 41/349 (11.7%)
20/26 (76.9%) 5/26 (19.2%) 1/26 (3.8%)
432/508 (85%) 68/508 (13.4%) 8/508 (1.6%) <.001‡
45/349 (12.9%) 136/349 (39%) 168/349 (48.1%)
14/26 (53.8%) 10/26 (38.5%) 2/26 (7.7%)
360/508 (70.9%) 127/508 (25%) 21/508 (4.1%) <.001§
313/349 (89.7%) 30/349 (8.6%) 6/349 (1.7%)
15/26(57.7%) 9/26 (34.6%) 2/26 (7.7%)
342/508 (67.3%) 142/508 (28%) 24/508 (4.7%) <.001k
219/349 (62.8%) 94/349 (26.9%) 36/349 (10.3%)
20/26 (76.9%) 5/26 (19.2%) 1/26 (3.8%)
422/508 (83.1%) 77/508 (15.2%) 9/508 (1.8%) <.001{
214/349 (61.3%) 96/349 (27.5) 39/349 (11.2%)
19/26 (73.1%) 6/26 (23.1%) 1/26 (3.8%)
402/508 (79.1%) 89/508 (17.5%) 17/508 (3.3%)
EDITS ¼ Erectile Dysfunction Inventory of Treatment Satisfaction. *P ¼ .422 for the malleable vs 2-piece; P < .001 for the malleable vs 3-piece; P ¼ .160 for the 2-piece vs 3-piece. † P ¼ .396 for the malleable vs 2-piece; P < .001 for the malleable vs 3-piece; P ¼ .227 for the 2-piece vs 3-piece. ‡ P < .001 for the malleable vs 2-piece; P <0.001 for the malleable vs 3-piece; P ¼ .174 for the 2-piece vs 3-piece. § P < .001 for the malleable vs 2-piece; P < .001 for the malleable vs 3-piece; P ¼ .555 for the 2-piece vs 3-piece. k P ¼ .311 for the malleable vs 2-piece; P < .001 for the malleable vs 3-piece; P ¼ .356 for the 2-piece vs 3-piece. { P ¼ .381 for the malleable vs 2-piece; P < .001 for the malleable vs 3-piece; P ¼ .500 for the 2-piece vs 3-piece.
infection (grade IIIb). In these patients, new penile implants were reinserted after removal of malleable prosthesis and washout. As postoperative late complications, a total of 70 patients (7.9%) underwent revision surgery because of dissatisfaction, perforation, or device malfunction. There were significant differences in terms of revision rate and causes among the groups (Table 5). Of the patients who had a malleable implant, 27 (7.7%) underwent 3-piece penile prosthesis implantation due to dissatisfaction; however, only 1 (0.2%) of the patients with a 3-piece implant was switched to malleable implant (P < .001). The highest rate of revision surgery due to penile corporal perforation was in the malleable group, whereas the highest rate of revision surgery due to penile implant malfunction occurred in the 3-piece implant group (P ¼ .021 and .001, respectively). In addition, penile implant malfunction was due to rupture of the cylinders in 2 (0.6%) patients in the malleable implant group and 4 (0.8%) patients in the 3-piece implant group, pump failure J Sex Med 2019;16:1092e1099
in 1 (3.8%) patient in the 2-piece implant group and 16 (3.1%) patients in the 3-piece implant group, reservoir tear in 5 (1%) patients and blowout in the reservoir to pump tubing in 3 (0.8%) patients in the 3-piece implant group. The rate of and reason for penile implant malfunction such as pump failure (P ¼ .578), reservoir tear (P ¼ .987), blowout in the reservoir to pump tubing (P ¼ .901), and cylinder tear (P ¼ .897) were found to be insignificant among the 3-piece implant subgroups (Table 5). To analyze risk factors, using multivariate analysis, as shown in Table 6, there was no observed predictive effect of risk factors such as patient and partner age, diabetes, neurologic disorders, vascular disease, pelvic surgery, and penile disorders on couples’ dissatisfaction; however, presence of complications was only the predictor that might cause couples’ dissatisfaction (P ¼ .003). In addition, etiologic risk factors did not have any effect on any of the complications.
1096
Çayan et al
Table 3. Results of the modified EDITS questionnaire according to the type and brands of the 3-piece implants
Overall, how satisfied are you with this treatment? Very satisfied Somewhat satisfied Dissatisfied To what degree has the penile prosthesis met your expectations? Completely Considerably Not at all How likely are you to continue to using the penile prosthesis? Very likely Moderately likely Unlikely How easy was it for you to use your penile prosthesis? Very easy Moderately easy Difficult How confident has the penile prosthesis made you feel about your ability to engage in sexual activity? Very confident Somewhat confident Less confident How satisfied is your partner with this treatment? Very satisfied Somewhat satisfied Dissatisfied
AMS 700 Ultrex Plus
AMS 700 CX
AMS 700 LGX
Coloplast Titan Mentor Alpha 1
46/51 (90.2%) 3/51(5.9%) 2/51 (3.9%)
150/161 (93.2%) 11/161 (6.8%) 0/161 (0%)
34/41 (82.9%) 6/41 (14.6%) 1/41 (2.4%)
232/255 (91%) 22/255 (8.6%) 1/255 (0.4%)
P value .060
.059 41/51 (80.4%) 7/51 (13.7%) 3/51 (5.9%)
140/161 (87%) 19/161 (11.8%) 2/161 (1.2%)
32/41 (78%) 7/41 (17.1%) 2/41 (4.9%)
219/255 (85.9%) 35/255 (13.7%) 1/255 (0.4%) .186
35/51 (68.6%) 12/51 (23.5%) 4/51 (7.8%)
123/161 (76.4%) 31/161 (19.3%) 7/161 (4.3%)
31/41 (75.6%) 8/41 (19.5%) 2/41 (4.9%)
171/255 (67.1%) 76/255 (29.8%) 8/255 (3.1%) .154
32/51 (62.7%) 14/51 (27.5%) 5/51 (9.8%)
113/161 (70.2%) 38/161 (23.6%) 10/161 (6.2%)
26/41 (63.4%) 12/41 (29.3%) 3/41 (7.3%)
171/255 (67.1%) 78/255 (30.6%) 6/255 (2.4%) .164
40/51 (78.4%) 9/51 (17.6%) 2/51 (3.9%)
140/161 (87%) 17/161 (10.6%) 4/161 (2.5%)
32/41 (78%) 8/41 (19.5%) 1/41 (2.4%)
210/255 (82.4%) 43/255 (16.9%) 2/255 (0.8%)
36/51 (70.6%) 11/51 (21.6%) 4/51 (7.8%)
134/161 (83.2%) 23/161 (14.3%) 4/161 (2.5%)
31/41 (75.6%) 7/41 (17.1%) 3/41 (7.3%)
201/255 (78.8%) 48/255(18.8%) 6/255(2.4%)
.192
EDITS ¼ Erectile Dysfunction Inventory of Treatment Satisfaction.
In the present study, the patient and partner satisfaction rates were significantly higher in the 3-piece implant group than in the malleable group, but no significant difference between the 2piece and 3-piece implant groups. There were no differences in terms of couples’ satisfaction according to brands of the penile implants. Otero et al12 compared patient and partner satisfaction between AMS 700 CX (Boston Scientific Corp) and Titan in 207 patients who had penile implant. They found that overall satisfaction was very high for both types of prosthesis, but more
DISCUSSION Few studies have compared patient and partner satisfaction for the 2 types of prostheses (comparison of 2 brands of inflatable implants, malleable vs 3-piece or malleable vs 2-piece).12e15 However, no study has compared 3 types of implants with all brands available on the market, and this is the first study to compare couples’ satisfaction in addition to long-term outcome of the implant surgery and predictors of dissatisfaction in the same study.
Table 4. Postoperative early complications, classified according to the modified Clavien system Grade I II IIIa IIIb VIa IVb V
Malleable (n ¼ 349)
2-piece (n ¼ 26)
3-piece (n ¼ 508)
P value
9/349 (2.6%) 6/349 (1.7%)
1/26 (3.8%) 1/26 (3.8%)
28/508 (5.5%) 11/508 (2.2%)
.114 .724
4/349 (1.1%)
0
2/508 (0.4%)
.357
None None None None
J Sex Med 2019;16:1092e1099
1097
Couples’ Satisfaction with Penile Implants
Table 5. Postoperative late complications, classified according to the modified Clavien system Causes of revision surgery
Malleable (n ¼ 349)
2-piece (n ¼ 26)
3-piece (n ¼ 508)
P value
Dissatisfaction with implant Penile corporal perforation Penile implant malfunction
27/349 (7.7%) 9/349 (2.6%) 2/349 (0.6%)
0 0 1/26 (3.8%)
1/508 (0.2%) 2/508 (0.4%) 28/508 (5.5%)
<.001 .021 .001
patients were satisfied with the AMS 700 CX. Kılıçarslan et al13 included 46 patients who underwent AMS 600/650 (Boston Scientific Corp) or AMS Ambicor prosthesis implantation. They reported higher satisfaction rates with the 2-piece inflatable prostheses when compared with malleable prostheses. Morgado et al14 compared overall patient satisfaction in 55 patients, using the EDITS questionnaire. They found no significant difference in EDITS score between the AMS 700 CX and Titan.14 The short-term satisfaction rate in 142 patients treated with penile implants has been reported, using the validated quality of life and sexuality with penile prosthesis questionnaire.15 They found high functional and patient satisfaction scores at 1 year after penile prosthesis surgery. Barton et al16 published a comprehensive review of available literature regarding sexual quality of life and satisfaction with penile prostheses. They reported patient satisfaction rates with penile prostheses as >85%, and sexual quality of life is improved in both patients and their partners. Many predictive factors, including patient age; type and brand of implant; obesity; systemic vascular comorbidities such as diabetes, hypertension, dyslipidemia, and thyroid disease; abdominal and pelvic surgeries for cancer or anatomic problems; Peyronie’s disease; and surgical complications related to penile implant surgery have been investigated for the patient and partner satisfaction in the published series.6,15,17 Habous et al17 investigated predictors of satisfaction, using a single question and scoring system in men who underwent penile implant surgery. Of the patients, 93% had high satisfaction (score 4). However, they found that patients with a major complication, with or
Table 6. Multivariate analysis of the parameters that might predict couples’ dissatisfaction 95% CI Parameters
P value
OR
Lower
Upper
Patient age Partner age Diabetes Neurologic disorders Vascular disease Pelvic trauma (surgical or external) Peyronie’s disease Complications
.362 .227 .242 .999 .505 .173
1.015 0.911 0.645 0.000 0.753 0.370
0.983 0.784 0.310 0.000 0.327 0.089
1.049 1.059 1.344 — 1.734 1.547
.816 .003
1.105 3.058
0.478 1.457
2.556 6.420
OR ¼ odds ratio. J Sex Med 2019;16:1092e1099
without an additional minor complication, had a higher likelihood of being dissatisfied (25%) compared with patients with no complication (1.9%) or only minor complication (3.7%). The overall satisfaction rate was higher in patients with inflatable implant than with a malleable implant. They suggested that major complications have a major impact on patient satisfaction. However, they did not assess partner satisfaction in their studies. Capogrosso et al15 found no association between erectile dysfunction etiology and patient satisfaction scores. However, they reported that surgeon experience emerged as the only independent predictor of higher satisfaction scores. However, they did not assess partner satisfaction in their studies. In the present study, the partner’s dissatisfaction rates were 3.3% in the 3-piece implants, 3.8% in the 2-piece implants, and 11.2% in the malleable implants, revealing significant difference among the 3 groups. When we analyzed risk factors, using multivariate analysis, presence of complication was only predictor that might cause couples’ dissatisfaction. Complications associated with penile implants have been categorized as major and minor or early and late complications, including infectious and non-infectious damage, device malfunction, and patient and partner dissatisfaction.6,8e11 Contemporary series of 3-piece penile prostheses report mechanical survival rates of 81e94%, 68e89%, and 57e76% at 5, 10, and 15 years, respectively. Infection risk varies from 0e25% in the literature, depending on morbidity and presence of revision surgery.18,19 Infection rates of current devices are 1e2% in first-time, low-risk populations, and 2e3% for higher risk groups, with patient and partner satisfaction at 92e100% and 91e95%, respectively. Standardization of surgical technique and improvements in device construction have reduced all-cause complication rates to <5% in recent reports.20,21 2-piece and malleable devices are associated with slightly higher mechanical reliability, but they have decreased patient satisfaction.3 In the present study, 7% had postoperative early complications, and there were no significant differences in minor complications among the groups. As postoperative late complications, 7.9% underwent revision surgery due to dissatisfaction, perforation, and device malfunction. There were significant differences in terms of revision rate and causes among the groups. Of the patients who had malleable implants, 27 (7.7%) underwent 3-piece penile prosthesis implantation due to dissatisfaction; however, only 1 (0.2%) of the patients with a 3-piece implant was switched to a malleable implant. The highest rate of revision surgery due to penile corporal perforation was in the malleable
1098
group (2.6%), whereas the highest rate of revision surgery due to penile implant malfunction occurred in the 3-piece implant group (5.5%).
Limitations Despite the important of the findings related to comparison of long-term complications, mechanical reliability and couples’ satisfaction according to penile implant types and brands in patients who underwent penile prosthesis implantation, our study has some limitations. Many studies have examined the effect of penile implants on patient or partner satisfaction, mostly using International Index of Erectile Function (IIEF) and EDITS questionnaires.16,22e24 Akakpo et al25 reviewed 48 articles examining patient satisfaction with penile prostheses and found that 66.2% of the articles reviewed used non-validated questionnaires in assessing satisfaction. Other rarely used tools include the Sexual Life Quality Questionnaire, Sexual Experience Questionnaire, Self-Esteem and Relationship Questionnaire, and Quality of Life and Sexuality with Penile Prosthesis.25 Therefore, in the present study, we used modified EDITS questionnaire, which is mostly used in the studies, although it is non-validated instrument with sub-optimally measurement of satisfaction. In addition to the modified EDITS questionnaire, preimplantation and postimplantation IIEF questionnaires have been used, and partner satisfaction has been specifically assessed in some studies. Vakalopoulos et al17 evaluated patients’ erectile function and couples’ satisfaction after 3-piece penile prosthesis implantation, and they found the mean IIEF score significantly increased after surgery, with high rates of patient and partner satisfaction. In their study, patient satisfaction appeared independent of prosthesis type and cylinder length. In our study, we did not include an IIEF questionnaire to assess postoperative erectile function with the implant, and an additional validated questionnaire was not used to specifically assess female partners.
CONCLUSION Overall, all types and brands of penile implants have high level of treatment success, mechanical reliability, and couples’ satisfaction with very low complication rates. But 3-piece and 2-piece implants have higher couple satisfaction rates than malleable implant. Brands of the implants did not have any effect on the couples’ satisfaction. Regarding detail of the complications, the 3-piece implant has a lower rate of penile corporal perforation and a higher rate of penile implant malfunction than the malleable implant. Patients with erectile dysfunction who need a penile implant should be informed about surgical outcomes, brands, and types of penile implants. Prosthesis choice should be customized to individual patient’s expectations/conditions and tailored accordingly. Corresponding Author: Selahittin Çayan, MD, FECSM, University of Mersin School of Medicine, Department of
Çayan et al
Urology, 33079 Mersin, Turkey. Tel: þ90 532 346 0509; Fax: þ90 324 337 3738; E-mail: [email protected] Conflicts of Interest: The authors report no conflicts of interest. Funding: None.
STATEMENT OF AUTHORSHIP Category 1 (a) Conception and Design Selahittin Çayan; Ozan Efesoy; Ramazan As¸cı; Önder Yaman (b) Acquisition of Data Selahittin Çayan; Ozan Efesoy; Ramazan As¸cı; Mustafa Suat Bolat; Erdem Akbay; Önder Yaman (c) Analysis and Interpretation of Data Selahittin Çayan; Ozan Efesoy; Erdem Akbay Category 2 (a) Drafting the Article Selahittin Çayan; Ramazan As¸cı; Önder Yaman (b) Revising It for Intellectual Content Selahittin Çayan; Ramazan As¸cı; Önder Yaman Category 3 (a) Final Approval of the Completed Article Selahittin Çayan; Ramazan As¸cı; Önder Yaman
REFERENCES 1. Burnett A, Nehra A, Breau RH, et al. Erectile Dysfunction: AUA guideline. J Urol 2018;200:633-641. 2. Hatzimouratidis K, Giuliano F, Moncada I, et al. EAU guidelines on male sexual dysfunction. Arnhem, The Netherlands: EAU Guidelines Office; 2018. 3. Trost L, Hellstrom WJ. History, contemporary outcomes, and future of penile prostheses: A review of the literature. Sex Med Rev 2013;1:150-163. 4. Trost L, McCaslin R, Linder B, et al. Long-term outcomes of penile prostheses for the treatment of erectile dysfunction. Expert Rev Med Devices 2013;10:353-366. 5. Hellstrom WJ, Montague DK, Moncada I, et al. Implants, mechanical devices, and vascular surgery for erectile dysfunction. J Sex Med 2010;7(part 2):501-523. 6. Levine LA, Becher E, Bella A, et al. Current recommendations from the International Consultation on Sexual Medicine. J Sex Med 2016;13:489-518. 7. Welliver C. Optimizing outcomes in the virgin penile ımplant patient. Curr Urol Rep 2019;20:14. 8. Krzastek SC, Smith R. An update on the best approaches to prevent complications in penile prosthesis recipients. Ther Adv Urol 2019;11:1-9. 9. O’Rourke TK Jr, Erbella A, Zhang Y, et al. Prevention, identification, and management of post-operative penile implant complications of infection, hematoma, and device malfunction. Transl Androl Urol 2017;6(Suppl. 5):S832-S848. 10. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: A new proposal with evaluation in a cohort of J Sex Med 2019;16:1092e1099
Couples’ Satisfaction with Penile Implants
1099
6336 patients and results of a survey. Ann Surg 2004; 240:205-213.
prosthesis implants: Up to 7.7 years of follow-up. J Urol 2011; 185:614-618.
11. Vakalopoulos I, Kampantais S, Gkagkalidis K, et al. Complications of inflatable penile prostheses implantation classified according to the modified Clavien system. Adv AndrolVolume 2014; Article ID 127693, 5 page.
19. Montgomery BD, Lomas DJ, Ziegelmann MJ, et al. Infection risk of undergoing multiple penile prostheses: An analysis of referred patient surgical histories. Int J Impot Res 2018; 30:147-152.
12. Otero JR, Cruz CR, Gomez BG, et al. Comparison of the patient and partner satisfaction with 700CX and Titan penile prostheses. Asian J Androl 2017;19:321-325. 13. Kılıçarslan H, Kaynak Y, Gökçen K, et al. Comparison of patient satisfaction rates for the malleable and two-piece-inflatable penile prostheses. Turk J Urol 2014;40:207-210. 14. Morgado A, Cavadas AS, Pacheco Figueiredo L, et al. Longterm patient-reported satisfaction with different inflatable penile prosthesis: Comparison between AMS 700CX and Coloplast Titan. Rev Int Androl 2018;16(3):112-118. 15. Capogrosso P, Pescatori E, Caraceni E, et al. Satisfaction rate at 1-year follow-up in patients treated with penile implants: Data from the multicenter prospective registry INSIST-ED. BJU Int 2019;123:360-366. 16. Barton GJ, Carlos EC, Lentz AC. Sexual quality of life and satisfaction with penile prostheses. Sex Med Rev 2019;7: 178-188. 17. Habous M, Tal R, Tealab A, et al. Predictors of satisfaction in men after penile implant surgery. J Sex Med 2018;15: 1180-1186. 18. Carson CC, Mulcahy JJ, Harsch MR. Long-term infection outcomes after original antibiotic impregnated inflatable penile
J Sex Med 2019;16:1092e1099
20. Scherzer ND, Dick B, Gabrielson AT, et al. Penile prosthesis complications: Planning, prevention, and decision making. Sex Med Rev 2019;7:349-359. 21. Eid JF, Wilson SK, Cleves M, et al. Coated implants and “no touch” surgical technique decreases risk of infection in inflatable penile prosthesis implantation to 0.46%. Urology 2012;79:1310-1315. 22. Althof SE, Corty EW, Levine SB, et al. EDITS: Development of questionnaires for evaluating satisfaction with treatments for erectile dysfunction. Urology 1999;53:793-799. 23. Lux M, Reyes-Vallejo L, Morgantaler A, et al. Outcomes and satisfaction rates for the redesigned 2-piece penile prosthesis. J Urol 2007;177:262-266. 24. 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. 25. Akakpo W, Pineda MA, Burnett AL. Critical analysis of satisfaction assessment after penile prosthesis surgery. Sex Med Rev 2017;5:244-251.