Implantation de prothèse pénienne : un seul centre 25 ans d’expérience

03 septembre 2021

Auteurs : B. Topuz, T. Ebilo?lu, M. Zor, E. Kaya, S. Sar?kaya, A. Emrah Co?uplugil, M. Gürdal, S. Bedir
Référence : Prog Urol, 2021, 11, 31, 663-670




 




Introduction


Penile prosthesis implantation (PPI) is an important treatment option for organic erectile dysfunction (ED), where treatment methods such as oral drug therapy, vacuum erection device, intracavernosal injection and intraurethral suppository fail [1, 2]. In recent years, thanks to advances in surgical approaches, technology and devices, it continues to be the gold standard in tertiary treatment for refractory erectile dysfunction [3, 4].


Generally, penile prostheses are divided into malleable and inflatable types [4]. Malleable penile prostheses or semirigid penile protheses are known as one-piece prosthesis (1-PPP), while inflatable penile prostheses (multi-piece) have 2-piece (2-PPP) and 3-piece (3-PPP) types. For the first time, Scott et al. produced inflatable penis prosthesis in the year 1973 [4]. Since then, notable improvements have been experienced in mechanical and functional results. By the decrease in morbidity and increase in the level of satisfaction, patient preference has positively changed in favor of penile prosthesis [2, 5]. The implant technique of 1-PPPs is easy. It provides a sufficient rigid penis which may also be a complain in daily life. Lack of reservoir in 2-PPP's makes the surgical technique easier, but 3-PPPs are the prostheses that best imitate proper penile flaccidity and functional rigidity. Recently, 3-PPP is the most used type of penile prothesis.


Despite all these positive developments in prostheses, unfortunately, intraoperative complications such as urethral injury, bleeding, and postoperative complications such as prosthesis infection and mechanical malfunctions are still observed [5, 6]. Some of the complications require revision surgery. Intraoperative complications are less common than postoperative complications. Mechanical survival after implantation of penile prosthesis is around 69.5-83.2% at the 5th year [7]. Prosthetic infection is a feared complication of this surgery and has been recorded in approximately 0.5-9% of the cases [7, 8, 9]. The average risk of infection for penile prostheses is about 5% [5]. In experienced centers, this rate decreases to 2% [5]. Another problem is that although erection can be achieved with a penile prosthesis, sometimes patient satisfaction may not be at a sufficient level. Therefore, the function of the prosthesis and the expectations from prosthesis surgery should be explained to the patient in detail in the preoperative period. Especially with the use of inflatable penile prostheses, satisfaction rates have exceeded 90% [5, 7].


In various studies in the literature, long-term results of single (1-PPP) and multi-piece (2-PPP and 3-PPP) penile prostheses have been evaluated independently or comparatively [2, 3, 7, 10]. However, maximum 20-year follow up results were published in the literature. In this research, we express our maximum 25-year follow up results (a quarter of a century). Our aim in this study is to examine the long-term results of penile prostheses, the rates of complications and revision surgery, and patient satisfaction in our center.


Material and methods


Participants and study design


In this retrospective study, following the approval of the Gülhane Training and Research Hospital ethics committee (Meeting No.: 2020/19, Project No.: 2020-452), 138 patients who underwent penile prosthesis implantation due to organic erectile dysfunction between January 1996 and December 2020 were included in the study. The data of the patients were derived from the patient files and digital recording system and transferred to the follow-up cards. In addition, eligible patients were interviewed face to face, and ineligible patients were called by phone and the necessary information was obtained. The incusion criteria for PPI was confirmed ED unresponsive to PDE-5 inhibitors, vacuum erection device or intracavernous agents without any previous surgiries for this condition. The exclusion criteria for PPI was having a bleeding disorder or having a cavernousal skatris due to previous surgiries. The patients in whom implantation of penile prosthesis is indicated were informed about prosthesis surgery and written informed consent was obtained.


The patients were examined in terms of age, etiology, type of prosthesis, and incision, operation time (min), urethral catheter indwell time (days) and hospital stay (days).


In our clinic, for a malleable penile prosthesis (1-PPP), AMS Spectraâ„¢ and Genesis®; for inflatable 2-PPP, AMS Ambicorâ„¢; and for inflatable 3-PPP, AMS 700â„¢ series and Coloplast Titan® were applied. In the selection of penile prosthesis, the health status, economic availability and education level of the patients were taken into consideration. Psychiatric consultation was obtained before surgery. Routinely, antibiotics were started to be administered preoperatively 1 day before surgery and continued for 3 days postoperatively.


Antibiotic types, applied concurrent surgeries, presence and type of complications, time to prosthesis infection, presence and type of revision surgery were recorded. The correlation between complications and antibiotic prophylaxis regimen or prosthesis type; and the correlation between patient satisfaction and antibiotic prophylaxis regimen were investigated.


The success of the prosthesis was defined as very satisfied, satisfied, somewhat satisfied, or not satisfied at all after one year from the operation. At this point, the modified Erectile Dysfunction Treatment Satisfaction questionnaire (EDITS) was used to assess patients' satisfaction after treatment (2). The patients were contacted face-to-face interaction if possible. If it is not possible, a phone connection was made.


Surgical approach and postoperative period


A Foley urethral catheter was placed before the prosthetic surgery. After shaving and disinfecting the surgical site with antiseptic solution (povidone-iodine) for 20min, we applied the implantation under general anesthesia using an infrapubic or penoscrotal approach. After placing suspension sutures in the corpus cavernosum, an approximately 2cm long corporatomy incision was made. After the corpus cavernosum was sufficiently dilated, the inner part was irrigated with a mixture of gentamicin+rifampicin+saline solution. The components of the penile prosthesis were also washed with this solution and mounted appropriately. After the incisions were closed, a light elastic bandage was applied to the penis. A drainage catheteter was not placed routenely. Patinets we instructed to fix the penis to the suprapubic region while healing. The permission for the use was started at 4-6 week from surgery. At first coits, couple was advised to use lumricants.


Statistical analysis


Statistical analysis was done using Statistical Package for Social Sciences 25.0 software (SPSS 25.0 for MAC) by an expert biomedical statistician. Descriptive statistics of non-continuous samples were expressed with numbers and percentiles. Shapiro-Wilk, Kurtosis, and Skewness Tests were used to assess the continuous variables' normalization. After this procedure, descriptive statistics of continuous variables without normal distribution were expressed as median (minimum-maximum), and descriptive statistics of continuous variables with normal distribution were expressed as mean±standard deviation (minimum-maximum). Chi2 Test was used to compare the independent non-continuous samples. Kendall's Correlation Test or Spearman Correlation Test was used to correlate two nominal samples. Probability of P <0.05 was accepted as significant difference.


Results


The median age of 138 patients was 56 (21-83) years. The median follow up time was 16 (2-25) years. The etiological evaluation of patients with erectile dysfunction is summarized in Table 1.


We used 14 (10.2%) 1-PPP, 46 (33.3%) 2-PPP and 78 (56.5%) 3-PPP. Types of implants and approaches are summarized in Table 2.


The median operation time was 130 (90-270) min. The median time to urethral catheter removal and hospitalization time was 2 (1-10) and 8 (1-35) days, respectively.


The mostly used antibiotic prophylaxis regimen was teicoplanin+amikacin in 107 (77%) patients. The remaining 31 (23%) patients received the combination of vancomycin or/and ceftriaxone or/and gentamicin.


There was no complication in 96 (70%) patients. However, 42 (30%) patients faced some complications: Thirteen (9%) had prosthesis infection [9 (6.5%) had only prosthesis infection, 2 (1.44%) had prosthesis infection+prosthesis erosion, 2 (1.44%) had prosthesis infection+urethral injury]. Eight (5.8%) of prosthesis infection occurred in the first 3 months, 2 (1.4%) between 3 months and first year, and 3 (2.2%) one year after the surgery.


Salvage and revision surgery was applied to 27 (19.5%) patients. The detailed description of the complications and salvage and revision surgery is shown in Table 3.


As described in Table 3, only 2 (1.44%) patients with prosthesis infection did not undergo salvage or revision surgery, and they were treated only with antibiotics. The remaining patients were treated with salvage and revision surgery.


Concomitantly to the implantation surgery, 4 (2.8%) patients had artificial urinary sphincter implantation, 2 (1.4%) had inguinal hernia repair, 1 (0.7%) had TUR-prostate, 1 (0.7%) had TUR-bladder-neck, 1 (0.7%) had varicocelectomy, 1 (0.7%) had testicular sperm extraction, 1 (0.7%) had verruca excision, 1 (0.7%) had vasectomy. Complications occurred in 5 (41.7%) of these patients. The complication rate was 41.7% in patients who underwent concomitant surgical procedures with PPI and 29.4% in those who did not. Although the complication rate was higher in patients who underwent concomitant surgery, it was not statistically significant (P =0.376). The prothesis infection occurred in 2 (16%) of these patients. The prothesis infection rate was 16% in patients who underwent concomitant surgical procedures with PPI and 8% in those who did not. Although the prothesis infection rate was higher in patients who underwent concomitant surgery, it was not statistically significant (P =0.368).


Examining the etiological factors and prothesis infection rates, there was no significant factor that may cause a likelihood for prothesis infection (P =0.753). Especially looking for the diabetes mellitus, the prothesis infection rate was 11% in patients who had diabetes mellitus and 8% in those who did not. Although the prothesis infection rate was higher in patients with diabetes mellitur, it was not statistically significant (P =0.412).


The patients described their satisfaction level as very pleased (n =37; 26.8%), satisfied (n =64; 46.4%), somewhat satisfied (n =22; 15.9%) and 15 (n =15; 10.9%) patients were not satisfied at all 1 year after the operation.


There was no correlation between the antibiotic prophylaxis regimen and complications, antibiotic prophylaxis regimen and patient's satisfaction, prosthesis type and complications, or prothesis type and patient's satisfaction (P =0.488, P =0.144, P =0.454, P =0.336 respectively) (Table 4).


The penile prosthesis infection occurred in 1 (7.1%) of 14 patients with 1-PPP, 3 (6.5%) of 46 patients with 2-PPP, and 9 (11.6%) of 78 patients with 3-PPP. The rate of penile prosthesis infection showed a slight increase favoring 3-PPP without any statistically significant difference (P =0.633).


Patients who had complications expressed extreme dissatisfaction relative to the patients without complications (P =0.001) (Table 5).


Discussion


The patient and the doctor have some expectations from the penile prosthesis. These can be specified as follows; near-normal penile flaccidity and rigidity, long-term satisfactory functional results without any mechanical failure. In our study, we evaluated the long-term results, complication rates and patient satisfaction of single and multi-piece penile prostheses in line with the above-mentioned expectations.


When the studies were reviewed, the age distribution of patients with penile prosthesis varied within a very wide range between the 2nd and 8th decades [2, 4, 6, 10]. The 5th and 6th decades stand out for the average patient age [2, 4, 6, 10]. In our study, the average age (56 years) and distribution of ages (21-83 years) were similar to the literature data.


The most common etiology of erectile dysfunction in this patient group was diabetes mellitus (21.6-33.3%) followed by vascular diseases (16.7-31.9%) [4, 10, 11, 12, 13]. Less frequently seen etiologies were Peyronie's disease, neurological diseases, trauma, pelvic surgeries such as radical prostatectomy, iatrogenic causes, priapism, spinal cord injury and radiotherapy [4, 10, 11, 12, 13]. In our data, vascular diseases (n =57; 41%) were noted more frequently than diabetes mellitus (n =43; 31%).


Previously, the infrapubic approach was adopted for the implantation of multiple-piece penile prostheses for reasons such as faster implant insertion and easier placement of reservoirs. However, in the infrapubic approach, problems such as high risk of injury to the sensory nerves, difficulty in placing the pump, and invisible urethra emerged, and it was replaced by the penoscrotal approach [14]. Penoscrotal approach appears to be more advantageous for the implantation of multi-piece penile prostheses and is preferred more frequently [14, 15]. In a study, the penoscrotal approach was preferred in 80% of the cases, and a longer prosthesis length was achieved with the penoscrotal approach (22.3cm vs 20.6cm), but no difference was found between the two approaches as for reservoir placement [15]. According to our data, the rate for 1-PPP implantation with the infrapubic approach was 5.1%, while it was 16.6% for 2-PPP implantation. Similarly, the rate for 1-PPP implantation with the penoscrotal approach was 5.1%, while it was 16.6% for 2-PPP implantation. In other words, the frequency of infrapubic and penoscrotal approaches in 1-PPP and 2-PPP implantation was reported to be equal. For 3-PPP, the infrapubic approach was preferred more frequently than the penoscrotal approach (50% and 6.5%, respectively). Due to the increase for penile prosthesis costs in recent years in country, we have had to prefer 2-PPP. The vast majority of the 3-PPP we applied belonged to the period 5 years ago.


The International Consultation on Sexual Medicine recommends the use of perioperative antibiotics for this surgery, including preoperative use of antibiotherapy against gram-positive and gram-negative bacteria, but does not suggest the type of antibiotic [16]. However, American Urological Association guidelines recommend prophylaxis with an amikacin plus 1./2. generation cephalosporin or vancomycin [16]. Alternatively, ampicillin+sulbactam, ticarcillin+clavulanate, piperacillin+tazobactam or amikacin+teicoplanin combinations can be used [17, 18]. We used amikacin+teicoplanin combination in most of the cases (n =107; 77%) as perioperative antibiotic prophylaxis with the recommendation of the hospital infection control committee.


Our total complication rate was 30% (n =42). Prosthesis infection constituted 9% (n =13) of these complications, most of which occurred within the first 3 months. In the literature, the average complication rates for penile prosthesis implantation varied widely as 7.5%, 13.5%, 16.2%, 18.5%, and 49% [2, 4, 10, 11, 19]. Prosthesis infection rate in studies is approximately 0.5-9% [7, 8, 9]. In this respect, according to the literature, our complication rate is slightly higher than the average, and our infection rate is at the upper limit. Parallel to our slight high complication rates, our urethral catheter removal and hospitalization time was higher, too.


Although we found the prosthesis infection more in 3-PPP (11.6%) implants, this rate was not statistically significant (P =0.633). Only 2 (1.44%) of 13 patients with prosthetic infection were treated with antibiotics. The remaininng penile implants were removed (7.56%) and some were re-applied. Ji et al. detected prosthesis infection in only 1 (1.4%) of their series of 74 patients and removed this prosthesis [4]. On the other hand, Morgado et al. used inflatable penile implants in 55 patients, and they did not report any prosthetic infection [10]. Chierigo et al. reported prosthesis infection in only 1 patient (4.5%) in a large series of 149 patients in which they used inflatable penile implants and they changed the prosthesis of this patient [11]. Also, in our series, 2 (1.44%) of 13 patients with prosthesis infection were accompanied by prosthesis erosion, and 2 (1.44%) of them were accompanied by urethral injury. All of these prostheses were removed for these cases and 1-PPP was applied to some of them in the later dates. The rate of urethral injury for penile prosthesis surgery is between 0.1-4%, and it has been reported that urethral repair and prosthesis can be placed in the same session in mid and proximal urethral injuries [20]. However, the general information is that prosthetic surgery should be performed in another session in case of urethral injury.


Pump failure and reservoir leakage are important mechanical complications that negatively affect patient satisfaction. Çayan et al. explained the rate of pump failure as 6.9% and the rate of reservoir leakage as 1.8% [2]. In our series, these rates were 6.52% and 1.44%, respectively. In our series, 2 (1.44%) of 9 patients with pump failure did not undergo any revision surgery, but prostheses of patients with reservoir leakage were removed.


Pain after penile prosthesis is a relative concept and can sometimes adversely affect the quality of life. In a series of Chierigo et al. postoperative pain was reported for 3 (12%) patients, and prosthesis of one of these patient was extracted because of postoperative pain [11]. In our series, the frequency of pain was lower with 5.07% (n =7), while prostheses were removed in 4 of these patients. Similarly, there are patients in the literature whose prostheses were removed due to persistent pain [16]. Patients should be informed in advance that some patients may experience postoperative pain.


Although, our complication rate was found to be higher than the literature, but there was no significant relationship between antibiotic type and complications, and between type of prosthesis (1-PPP or 2-PPP or 3-PPP) and complications (P =0.488 and P =0.454, respectively).


Simultaneous surgical procedure with penile prosthesis implantation is a controversial issue. Urologists generally avoid concomitant surgery due to the risk of infection. It has been stated that concurrent circumcision causes an increased risk of infection in some studies, but not in others [21, 22]. It has been reported that simultaneous application of artificial urinary sphincter or ventral phalloplasty generally does not increase the risk of penile prosthesis infection [22]. We performed simultaneous surgical procedures in 12 (8.7%) patients, the most commonly artificial urinary sphincter implantation (n =4; 2.8%). Complications occurred in 5 (3.6%) of these patients. Although not statistically significant, the complication rate was higher in patients who underwent concomitant surgery (P =0.376). Prolonged operative times are associated with higher complications, so we think that shortening the total operative time is critical in concurrent surgeries. In this study, we experienced more complication rates when we applied a concomitant surgery, and we don't offer it.


Penile prostheses have a high (75-100%) patient satisfaction rate in the long term, although it varies according to the type of prosthesis compared to other treatments [3, 23, 24]. Satisfaction rates are expected to be high, as multi-piece penile prostheses are the devices that best imitate penile flaccidity and rigidity. In the study of Çayan et al. partial, and total satisfaction rates reported by the patients who had undergo penile prosthesis implantation were 90.3% for 1-PPP and 99.2% for 3-PPP, and a statistically significant difference was found between the two groups (P <0.001) [2]. Montorsi et al. stated that the overall satisfaction rate for 3-PPP was 92%, and the erection adequacy rate was 98% [25]. Chierigo et al. reported high satisfaction rate of 60% for 3-PPP [11]. Patient's expectation, education level, the success of the surgery and complications may affect satisfaction rates. In our study, considering all types of prostheses types 37 (26.8%) patients were very satisfied at the postoperative 1st year, and the total satisfaction rate was 89.1% (n =123). While no correlation was found between antibiotic type and patient satisfaction, patients with complications expressed dissatisfaction compared to those without complications (P =0.144 and P =0.001, respectively).


This study, in which we shared data of our twenty-five years of experience had several limitations. The first was its retrospective design. Second, prosthetic surgeries were not performed by the same urologist. Third, it was not possible to interview face to face with some of our patients. Fourth, questioning forms were not used while evaluating patient satisfaction. Despite these limitations, our study provides valuable information about the long-term results, complications and patient satisfaction from single (1-PPP) and multi-piece (2-PPP and 3-PPP) penile prostheses.


Conclusion


While the vast majority of patients were satisfied with their penile prostheses, patients who experienced complications did not express satisfaction. In our series, penile prosthesis implantation seems to be a recommended treatment method with high patient satisfaction in the treatment of refractory erectile dysfunction.


Ethics statement


The present study protocol was reviewed and approved by the institutional review board of Gülhane Training and Research Hospital, Ankara, Turkey (Meeting No: 2020/19, Project No: 2020-452).


Funding


The authors received no financial support for the research, authorship, and/or publication of this article.


Disclosure of interest


The authors declare that they have no competing interest.




Table 1 - Etiological factors associated with erectile dysfunction.
Etiological factors  No. Pts. (%) 
Vascular pathology  57 (41) 
Diabetes mellitus  43 (31) 
Pelvic surgery  17 (12.3) 
Peyronie disease  9 (6.5) 
Trauma  6 (4.3) 
Priapism  4 (2.9) 
Hormonal insufficiency (ADT)  1 (0.7) 
Pelvic radiotherapy  1 (0.7) 
Total  138 (100) 



Légende :
ADT: androgen deprivation therapy.



Table 2 - Types of implants and incisions used.
Types of implants  Infrapubic incision
No. Pts. (%) 
Penoscrotal incision
No. Pts. (%) 
Total
No. Pts. (%) 
1-PPP  7 (5.1)  7 (5.1)  14 (10.2) 
2-PPP  23 (16.6)  23 (16.6)  46 (33.3) 
3-PPP  69 (50)  9 (6.5)  78 (56.5) 
Total  99 (71.7)  39 (28.3)  138 (100) 



Légende :
1-PPP: 1-piece penile prosthesis; 2-PPP: 2-piece penile prosthesis; 3-PPP: 3-piece penile prosthesis.



Table 3 - Revision surgery according to the complications.
Complications  No. Pts. (%)  Types of salvage and revision surgeries 
Prosthesis infection  2 (1.44)  No need for surgery 
3 (2.17)  PPR and 1-PPPI 
1 (0.72)  PPR and 2-PPPI 
3 (2.17)  PPR 
Prosthesis infection+Prosthesis erosion  1 (0.72)  PPR and 1-PPPI 
1 (0.72)  PPR 
Prosthesis infection+Urethral injury  1 (0.72)  PPR and 1-PPPI 
1 (0.72)  PPR 
Pump failure  2 (1.44)  No need for surgery 
3 (2.17)  PPR and 2-PPPI 
3 (2.17)  Only pump revision 
1 (0.72)  PPR 
Pain  2 (1.44)  No need for surgery 
2 (1.44)  PPR and 3-PPPI 
3 (2.17)  PPR 
Wound infection  4 (2.89)  No need for surgery 
Dysuria  2 (1.44)  No need for surgery 
Reservoir leakage  2 (1.44)  PPR 
Cylinder leakage  1 (0.72)  PPR and 3-PPPI 
Concorde deformity  1 (0.72)  PPR and 3-PPPI 
Kinking  1 (0.72)  No need for surgery 
Bleeding  1 (0.72)  No need for surgery 
Urinary tract infection  1 (0.72)  No need for surgery 
Total  42 (30)   



Légende :
PPR: penile prosthesis removal; 1-PPPI: 1-piece penile prosthesis implantation; 2-PPPI: 2-piece penile prosthesis implantation; 3-PPPI: 3-piece penile prosthesis implantation.



Table 4 - Comparison of some characteristic features.
  Antibiotic regimens 
   
Complications  Teicoplanin +Amikacin  Others  Total  P  
Yes  31  11  42  P =0.488 
No  76  20  96 
Total  107  31  138 
  Antibiotic regimens 
   
Levels of satisfaction  Teicoplanin+Amikacin  Others  Total  P  
Very pleased  30  37  P =0.144 
Satisfied  48  16  64 
Somewhat satisfied  20  22 
Not satisfied at all  15 
Total  107  31  138 
  Complications 
   
Types of penile prostheses  Yes  No  Total  P  
1-PPP  14  P =0.454 
2-PPP  15  31  46   
3-PPP  21  57  78   
Total  42  96  138   
  Patients' levels of satisfaction 
   
Types of penile prostheses  Very pleased  Satisfied  Somewhat satisfied  Not satisfied at all  Total  P  
1-PPP  14  P =0.336 
2-PPP  11  25  46 
3-PPP  22  34  16  78 
Total  37  64  22  15  138 



Légende :
1-PPP: 1-piece penile prosthesis, 2-PPP: 2-piece penile prosthesis, 3-PPP: 3-piece penile prosthesis.



Table 5 - Patients' self-reported levels of satisfaction according to complications.
  Patients' levels of satisfaction 
 
  Very pleased  Satisfied  Somewhat satisfied  Not satisfied at all  Total  P  
Complications            P =0.001 
Yes  19  14  42 
No  36  45  14  96 
Total  37  64  22  15  138 




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