Asian Journal of Andrology (2022) 24, 32–39 www.asiaandro.com; www.ajandrology.com Open Access ORIGINAL ARTICLE Ten-year experience with penile prosthetic surgery Erectile Dysfunction Downloaded from http://journals.lww.com/ajandrology by BhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hC for the treatment of erectile dysfunction: outcomes ywCX1AWnYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC1y0abggQZXdgGj2MwlZLeI= on 01/11/2024 of a tertiary referral center and predictors of early prosthetic infection Franco Palmisano1, Luca Boeri2, Riccardo Ievoli3, Josvany Sánchez-Curbelo4, Matteo Giulio Spinelli2, Andrea Gregori1, Antonio Maria Granata1, Eduard Ruiz-Castañé4, Emanuele Montanari2, Joaquim Sarquella-Geli4 We aimed to evaluate ten-year outcomes of penile prosthesis (PP) implantation for the treatment of erectile dysfunction and to assess predictors of early prosthetic infection (EPI). We identified 549 men who underwent 576 PP placements between 2008 and 2018. Univariate and multivariate analyses were used to identify potential predictors of EPI. An EPI predictive nomogram was developed. Thirty-five (6.1%) cases of EPI were recorded with an explant rate of 3.1%. In terms of satisfaction, 82.0% of the patients defined themselves as “satisfied,” while partner’s satisfaction was 88.3%. Diabetes (P = 0.012), longer operative time (P = 0.032), and reinterventions (P = 0.048) were associated with EPI risk, while postoperative ciprofloxacin was inversely associated with EPI (P = 0.014). Rifampin/gentamicin-coated 3-piece inflatable PP (r/g-c 3IPP) showed a higher EPI risk (P = 0.019). Multivariate analyses showed a two-fold higher risk of EPI in diabetic patients, redo surgeries, or when a r/g-c 3IPP was used (all P < 0.03). We showed that diabetes, longer operative time, and secondary surgeries were the risk factors for EPI. Postoperative ciprofloxacin was associated with a reduced risk of EPI, while r/g-c 3IPP had higher EPI rates without an increased risk of PP explant. After further validation, the proposed nomogram could be a useful tool for the preoperative counseling of PP implantation. Asian Journal of Andrology (2022) 24, 32–39; doi: 10.4103/aja.aja_27_21; published online: 04 May 2021 Keywords: Boston; Coloplast Titan three-piece penile prosthesis; erectile dysfunction; impotence; Inhibizone; patient satisfaction; penile prosthesis; prosthesis infection; rifampin soaking INTRODUCTION In this context, PP has been associated with high rates of Erectile dysfunction (ED) is defined as the inability to attain or treatment-related satisfaction. One year after surgery, patients with maintain penile erection sufficient for successful vaginal intercourse.1 PP reported high satisfaction in terms of prosthesis function, patients’ ED commonly affects men older than 40 years of age, with a reported relationship with their partners and the outside world, as well as prevalence of 2%–9% in men between the ages of 40 and 49 years, then perceived self-image.6 Moreover, PP was found to work properly even increasing to 20%–40% in men aged 60–69 years, and up to 50%–100% at very long follow-up after the original implant (e.g., >10 years).7 in patients older than 70 years.2 On the other hand, this type of surgery is not devoid of potential Diabetes mellitus, hypertension, hyperlipidemia, metabolic complications.8 Most of the clinical research on this topic has mainly syndrome, depression, and lower urinary tract symptoms are focused on the identification of risk factors for PP-related complications, well-known risk factors for ED.3 In addition, a large proportion of such as ischemia of the glans penis and prosthetic infection, in order to patients suffer from iatrogenic ED, mainly due to pelvic surgery.4 adopt the best prevention strategies. However, a data-driven nomogram Penile prosthesis (PP) implantation is considered a valuable option for the prediction of early prosthetic infections (EPI) is lacking. for ED patients who do not respond to pharmacotherapy or who The aim of this study was to investigate the ten-year experience prefer a permanent solution to their problem; nevertheless, the most of PP implantation of a tertiary referral center with the specific focus recent American Urological Association (AUA) Guideline statement on surgical outcomes, related complications, and patient’s satisfaction. suggests considering PP, irrespective of previous attempts of medical Moreover, we aimed to build a predictive nomogram for postoperative management.3–5 infectious complications. 1 ASST Fatebenefratelli-Sacco, Department of Urology, Luigi Sacco University Hospital, Milan 20157, Italy; 2IRCCS Foundation Ca’ Granda Ospedale Maggiore Policlinico, Department of Urology, University of Milan, Milan 20122, Italy; 3Department of Economics and Management, University of Ferrara, Ferrara 44121, Italy; 4 Fundació Puigvert, Department of Andrology, University of Barcelona, Barcelona 08025, Spain. Correspondence: Dr. F Palmisano (franco.palmisano@hotmail.it) Received: 03 September 2020; Accepted: 04 March 2021 Penile prosthesis: outcomes and infection predictors F Palmisano et al 33 PATIENTS AND METHODS study also guaranteed compliance at all times with Law 15/1999 on In this retrospective study, we identified all men seeking medical Protection of Personal Data (Spanish Government). attention for ED at a single tertiary referral center (Fundació Puigvert, Statistical analyses Department of Andrology, University of Barcelona, Barcelona, Spain) R software was used for statistical analysis (R Core Team, 2016; who underwent PP implantation between January 2008 and October R Foundation for Statistical Computing, Vienna, Austria). Statistical 2018. significance for the tests was set at P = 0.05. Patients were assessed with a detailed medical and sexual history The Shapiro–Wilk test was applied to assess the normality Downloaded from http://journals.lww.com/ajandrology by BhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hC along with a general physical and andrological examination. Surgical of numerical variables. Continuous variables were presented as procedures were performed by the same experienced surgical team. mean ± standard deviation (s.d.), while categorical variables were In particular, high-volume implanters (HVIs) were considered if they ywCX1AWnYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC1y0abggQZXdgGj2MwlZLeI= on 01/11/2024 summarized as number (percentage). have placed >15 PPs in the preceding year. If surgery was conducted by Descriptive statistics were used to describe and to investigate a surgeon-in-training/low-volume implanter (LVI), a HVI was always potential factors associated with EPI. The statistical significance present as a second operator. of differences in means was tested with the unpaired t-test and A standard antibiotic prophylaxis with the first-generation the Mann–Whitney U test, when appropriate. The statistical cephalosporins was administered preoperatively in the absence of significance of differences in proportions was tested with the Pearson allergy. Antibiotic selection at patient discharge was based on physician Chi-square test or the Fisher exact test. preference and patient’s specific factors, including allergies, home Multivariate, stepwise, logistic regression9 analysis tested the medications, and medical comorbidities. association between clinical variables (diabetes, rifampin/gentamicin- Intraoperative and postoperative features and adverse events were coated 3-piece inflatable PP [r/g-c 3IPP], redo surgery, and patient’s recorded. Based on a standard internal protocol, follow-up consisted in age) and risk of EPI. Finally, a nomogram was constructed in order to scheduled re-evaluations at 5 days, 12 days, and 28 days after surgery visualize and improve the understanding of the relationship between and then yearly. explanatory variables and the risk of EPI, particularly in terms of The diagnosis of EPI was suspected when one or more of the marginal effect and amount of probability. Package “rms” was used to following signs were found between the first week after surgery obtain the final nomogram.10 and up to 9 weeks postimplant: (i) leukocytosis with or without fever accompanied by penile erythema, (ii) wound dehiscence, and RESULTS (iii) discharge or skin necrosis. In patients with suspected EPI, empiric Baseline characteristics antibiotics were administered and culture swabs were collected from Mean patient’s age at surgery was 60.6 (s.d.: 9.5) years. Above all, wound discharge. Subsequently, antibiotic therapy was adapted to 166 (30.0%) men were current smokers and 175 (31.9%) were former culture results. Unresponsive patients to antibiotic treatment and/or smokers. Diabetes mellitus, obesity, and dyslipidemia were found in with signs of sepsis or systemic symptoms (i.e., body temperature 224 (40.8%), 141 (25.7%), and 248 (45.2%) men, respectively. Among >38°C, rigors, malaise, continuous local pain, and leukocytosis diabetic patients, 103 (18.8%) were insulin dependent and 121 (22.0%) >15 000 mm−3) were submitted to PP explant. were diet controlled. During explant procedure, all the components of the device Hypertension was found in 327 (59.6%) men, whereas cardiopathy were removed through a penoscrotal approach. The dissection was was reported in 99 (18.0%) patients. Peyronie’s disease and ischemic carried out using electrocautery to avoid inadvertently perforation of priapism were reported by 100 (18.2%) and 11 (2.0%) men, respectively. the implant, which could be lost in the surgical field. After removal, Previous pelvic surgery was the main cause of ED: 128 (23.3%) patients the surgical field was irrigated in a step-wise fashion using antibiotic underwent radical prostatectomy, 9 (1.6%) had radical cystectomy solution, hydrogen peroxide solution, and povidone-iodine solution. with orthotopic neobladder, and 3 (0.5%) had radical cystectomy with In order to break up the bacterial biofilm, the washout was performed ureterocutaneous vs ileal conduit diversion. Moreover, 5 (0.9%) men with high-pressure irrigation in order to maximize the antimicrobial underwent kidney transplant, 9 (1.6%) underwent colorectal surgery, purpose and the mechanical action. In selected cases with limited and 12 (2.2%) underwent other procedures. infectious process, the reservoir was not removed. Preoperative and operative variables Patient satisfaction was retrospectively evaluated using the medical Table 1 depicts the surgical approach and the type of PP used among records of each follow-up assessment. Satisfaction was categorized the whole cohort. Patients were usually admitted the day before surgery, as follows: “very satisfied,” if the patient was happy with the results and a standard antibiotic prophylaxis, first-generation cephalosporin, of the operation and reported satisfactory intercourses; “not very was administered preoperatively in 84.4% of subjects replacing it in satisfied,” if the patient reported a moderate satisfaction after surgery case of allergies; 10-min standard scrub with povidone-iodine and and an occasional use of the PP (for any reason); and “not satisfied” or chlorhexidine-alcohol was performed in all procedures. Antibiotic “dissatisfied,” if the patient clearly expressed his dissatisfaction about the treatment was continued for the duration of the hospitalization. For surgical outcome. Partner satisfaction was recorded and categorized as Coloplast™ devices, the antibiotic dip choice was always rifampin and “satisfied” or “not-satisfied.” Of 552 ED men, we excluded three cases gentamicin; the same solution was used for wound irrigation during performed in a transgender setting. A convenient sample of 576 PP the procedure. At the end of surgery, a compressive “mummy wrap™” implantations was considered for the final analysis. dressing was applied to the scrotum and penile shaft to minimize the This study was conducted according to the guidelines and principles risk of hematomas and to prevent local edema. Overall, the mean of the Declaration of Helsinki and standard ethical conduct for research operative time was 83.6 (s.d.: 29.2) min. At the end of the procedure, involving humans; after approval of the Institutional Review Board a closed suction drainage was inserted in 281 (48.8%) cases. Surgery of Fundació Puigvert, all patients signed informed consent agreeing was performed by an LVI in 116 (20.1%) cases and mean postoperative to supply their own anonymous data for this and future studies. The hospital stay was 1.4 (s.d.: 1) days. Asian Journal of Andrology Penile prosthesis: outcomes and infection predictors F Palmisano et al 34 A broad range of antibiotics was prescribed at discharge: Among patients who developed hematomas, one (2.6%) required a amoxicillin clavulanate in 301 (52.3%) cases, ciprofloxacin in surgical drainage, while in 2 (5.1%) patients, a re-suture was performed. 197 (34.2%) men, cefixime in 4 (0.7%), cefuroxime in 3 (0.5%), and In case of mechanical failure, a partial prosthesis replacement was ceftriaxone, clindamycin, trimethoprim sulfamethoxazole in 1 (0.2%) performed in 65.2% of cases, while in one case, a 2IPP was changed man each. Twenty-one (3.6%) patients did not receive antibiotics with a 3IPP. at discharge. Data on the postoperative antibiotics were missed in Overall, 35 (6.1%) EPI were reported, occurring within 6 weeks 47 (8.2%) patients. postoperatively in 88.5% of cases. EPI rate was 5.3% in first implants. Downloaded from http://journals.lww.com/ajandrology by BhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hC Table 3 details the characteristics of 35 patients with EPI. Intraoperative adverse events Ciprofloxacin was administered in 14.3% of patients, whereas The overall rate of intraoperative complications was low. A distal ywCX1AWnYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC1y0abggQZXdgGj2MwlZLeI= on 01/11/2024 62.9% received amoxicillin clavulanate. corpora perforation during dilatation was reported in two cases Cultured organisms were Escherichia coli, Staphylococcus/Streptococcus (0.3%). In 2 (0.3%) patients, a urethral stenosis did not allow a urinary spp., and Klebsiella pneumoniae in 8 (22.8%), 7 (20.0%), and 6 (17.1%) catheter placement. In one case (0.2%), a penoscrotal 3-piece PP was men, respectively. A PP explant was mandatory in 18 (3.1%) patients. unsuccessfully placed, and finally, a malleable PP was positioned with Table 4 depicts descriptive statistics of the whole cohort according a subcoronal incision. to the presence of EPI. Patients with EPI more frequently had a history Postoperative adverse events of diabetes mellitus (P = 0.012), longer operative time (P = 0.032), The overall rate of postoperative complication was 20.5%. Main and higher rates of reintervention (P = 0.048) than those without complication features are shown in Table 2. EPI. Similarly, r/g-c 3IPP showed a higher EPI risk (P = 0.019) but no Table 1: Types of penile prosthesis placed and surgical approach (n=576) Prosthesis type Approach Primary Secondary implant Total, n (%) implant PI PMF PE Malleable Penoscrotal 28 4 6 0 38 (6.6) Subcoronal 40 1 5 0 46 (8.0) Two‑piece inflatable Penoscrotal 33 0 4 0 37 (6.4) Three‑piece inflatable Rifampin/gentamicin‑coated Penoscrotal 181 7 13 3 204 (35.4) Rifampin/minocycline‑impregnated Infrapubic 23 0 0 0 23 (4.0) Penoscrotal 201 7 16 2 226 (39.2) In 2 cases, whereas 3‑piece prosthesis was placed, the infection prevention strategy was missed. PI: previous infection; PMF: previous mechanical failure; PE: previous extrusion Table 2: Postoperative complication after penile prosthesis implantation Complication Cases (n) Malleable (n) 2IPP (n) r/g‑c 3IPP (n) r/m‑i 3IPP (n) First implant (n) Early infection 35 5 0 21 9 27 Of which explanted 18 3 0 10 5 3 Hematoma 39 3 7 16 13 37 Erosion 12 2 2 6 2 7 Mechanical failure 23 0 2 8 13 18 Pump 7 NA 1 3 3 – Cylinders 2 0 0 0 2 – Reservoir 7 NA NA 4 3 – Not known 7 0 1 1 5 – Pain 7 2 0 2 3 7 Other 11 Pulmonary edema 1 1 0 0 0 1 Intestinal fistula 1 0 0 1 0 0 AUR 1 0 0 1 0 1 OCD 1 0 0 1 0 1 Pump revision (trouble activating PP) 1 NA 0 1 0 1 Pump revision (high risk of erosion) 1 NA 0 0 1 1 Reservoir herniation 1 NA NA 1 0 1 IIH 1 0 0 0 1 1 Orchiepididymitis 1 1 0 0 0 1 Fever (without local sign of infection) 1 0 0 1 0 1 Cylinders revision (concorde deformity) 1 0 0 1 0 1 Cylinders revision (for oversizing) 1 0 0 1 0 1 2IPP: two‑piece inflatable penile prosthesis; r/g‑c 3IPP: rifampin/gentamicin‑coated 3‑piece inflatable penile prosthesis; r/m‑i 3IPP: rifampin/minocycline‑impregnated 3‑piece inflatable penile prosthesis; AUR: acute retention of urine; OCD: obsessive‑compulsive disorder; IIH: incarcerated inguinal hernia; NA: not applicable; –: not applicable Asian Journal of Andrology Penile prosthesis: outcomes and infection predictors F Palmisano et al 35 Table 3: Early prosthetic infection: characteristics of 35 cases Patient Age Main causes of ED Prosthesis First implant Postoperative Cultured organism Explant number (year) type (yes/no) week to EPI (yes/no) 1 64 Obesity, TS r/g‑c 3IPP Yes 1 P. aeruginosa No 2 66 Prostatectomy r/g‑c 3IPP Yes 1 MD No 3 54 ExTS, obesity, diabetes, HT r/g‑c 3IPP Yes 1 E. cloacae + Achromobacter xylosoxidans No 4 40 TS, diabetes r/g‑c 3IPP Yes 4 Enterococcus spp. + Serratia odorifera No Downloaded from http://journals.lww.com/ajandrology by BhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hC 5 75 ExTS, obesity, diabetes, HT r/g‑c 3IPP Yes 7 Staphylococcus spp. No 6 41 TS, diabetes, HT, PD r/g‑c 3IPP Yes 3 K. pneumoniae No ywCX1AWnYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC1y0abggQZXdgGj2MwlZLeI= on 01/11/2024 7 56 TS, HT, PD r/g‑c 3IPP Yes 5 K. pneumoniae No 8 51 Obesity, diabetes, HT r/g‑c 3IPP Yes 3 E. cloacae + Corynebacterium spp. No 9 54 ExTS, diabetes, HT r/g‑c 3IPP yes 2 MD Yes 10 62 Diabetes, cystectomy r/g‑c 3IPP yes 2 S. haemolyticus Yes 11 67 MD r/m‑i 3IPP No 3 E. coli No 12 72 Prostatectomy r/g‑c 3IPP No 3 E. coli No 13 70 TS, cardiopathy, HT, diabetes r/g‑c 3IPP No 5 E. faecalis No 14 51 Prostatectomy, obesity, HT r/g‑c 3IPP Yes 1 B. circulans + M. morganii Yes 15 75 ExTS, cardiopathy, HT Malleable No 5 MD No 16 39 Cardiopathy r/m‑i 3IPP Yes 5 P. aeruginosa + S. marcescens Yes 17 58 TS, diabetes, HT, PD r/g‑c 3IPP Yes 6 K. pneumoniae Yes 18 60 ExTS, diabetes, Ht Malleable Yes 4 E. coli + Candida spp. Yes 19 59 ExTS, obesity, diabetes, HT, PD r/g‑c 3IPP Yes MD MD Yes 20 73 Diabetes, cardiopathy, HT, prostatectomy r/m‑i 3IPP No 2 K. pneumoniae + E. faecium + E. coli + Yes Bacteroides spp. 21 55 ExTS, diabetes, HT, depression, spinal cord injury r/m‑i 3IPP No 9 E. faecium + Staphylococcus spp. Yes 22 67 Cardiopathy, HT r/g‑c 3IPP Yes 7 MD Yes 23 60 TS, diabetes, cardiopathy, HT r/g‑c 3IPP No 3 E. coli + Staphylococcus spp. Yes 24 57 ExTS, obesity, diabetes, r/m‑i 3IPP No 5 Streptococcus spp. No 25 55 TS, obesity, cardiopathy, HT Malleable Yes 3 Enterobacter spp. No 26 54 TS, diabetes, cardiopathy, HT r/m‑i 3IPP Yes 2 E. coli + Bacteroides spp. Yes 27 37 Priapism r/g‑c 3IPP Yes 6 K. pneumoniae No 28 54 ExTS, diabetes, cardiopathy, HT, kidney transplant Malleable Yes 8 K. pneumoniae Yes 29 64 TS, diabetes, cardiopathy, HT, PD r/m‑i 3IPP Yes 4 K. pneumoniae Yes 30 74 TS, obesity, diabetes, HT, prostatectomy r/g‑c 3IPP Yes 5 E. coli No 31 63 Diabetes Malleable Yes 2 MD Yes 32 43 Not specified medullar disorder r/m‑i 3IPP Yes 2 S. epidermidis No 33 60 HT, prostatectomy r/m‑i 3IPP Yes 2 E. coli Yes 34 64 TS, diabetes r/g‑c 3IPP Yes 3 Inconclusive Yes 35 49 TS, diabetes, HT, PD r/g‑c 3IPP Yes 2 S. epidermidis Yes EPI: early prosthetic infection; ED: erectile dysfunction; TS: tobacco smoker; exTS: former tobacco smoker; HT: hypertension; PD: Peyronie’s disease; MD: missing data; r/g‑c 3IPP: rifampin/gentamicin‑coated 3‑piece inflatable penile prosthesis; r/m‑i 3IPP: rifampin/minocycline‑impregnated 3‑piece inflatable penile prosthesis; P. aeruginosa: Pseudomonas aeruginosa; E. cloacae: Enterobacter cloacae; K. pneumoniae: Klebsiella pneumoniae; E. coli: Escherichia coli; E. faecium: Enterococcus faecium; S. epidermidis: Staphylococcus epidermidis; S. haemolyticus: Staphylococcus haemolyticus; E. faecalis: Enterococcus faecalis; B. circulans: Bacillus circulans; M. morganii: Morganella morganii; S. marcescens: Serratia marcescens increased risk of explants (P > 0.05). Moreover, patient discharged with point three percent of partners defined themselves as satisfied; this rate ciprofloxacin showed a lower risk of EPI (P = 0.014). was higher considering 3IPPs (91.3%). Table 5 shows multivariate logistic regression model predicting Early prosthetic infection predictive nomogram EPI. A history of diabetes mellitus was significantly associated with EPI (odds ratio: 2.281; P = 0.0252). In addition, the probability of EPI Figure 1 shows the nomogram resulting from the proposed logistic was almost three times greater for redo surgery than for first implant model of Table 5, using EPI onset as the dependent variable and PP placement (odds ratio: 2.895, P = 0.0163). Finally, the probability age, diabetes, reintervention, and use of r/g-c 3IPP as predictors. For of EPI was higher for patient who underwent r/g-c 3IPP placement simplicity and its low statistical significance, age was omitted. The (odds ratio: 2.38, P = 0.0177). nomogram was created to visualize the predicted probability for a subject with certain characteristics, if prosthesis infection would be Follow-up and patient/partner satisfaction rates present within 9 weeks after surgery. To summarize these results, The mean follow-up was 14.6 (range: 1–67) months. Data regarding patients with all type of diabetes, not at the first implant, and receiving patient satisfaction were available in 40.5% of the cohort. Above all, a r/g-c 3IPP had the major risk of infection after surgery. 82.0% of the patients were satisfied, 7.3% were not very satisfied, and 10.7% were not satisfied. Satisfaction rates were 75.0%, 76.1%, and DISCUSSION 83.6% for malleable devices, 2IPP, and 3IPP, respectively. Data of In this study, we aimed to evaluate the outcomes of PP surgery at a partner satisfaction were available in only 29.9% of cases. Eighty-eight tertiary referral center and to investigate potential risk factors for early Asian Journal of Andrology Penile prosthesis: outcomes and infection predictors F Palmisano et al 36 Table 4: Descriptive statistics of the whole population according to early prosthetic infection presence Variable MD (n) EPI group, mean±s.d. or n (%) Non‑EPI group, mean±s.d. or n (%) P Age 0 58.4±10.4 60.8±9.4 0.145 ASA score >2 274 10 (35.9) 84 (31.1) 0.618 TS/exTS 0 24 (68.6) 330 (61.8) 0.423 Obesity (BMI >30 kg m−2) 10 11 (31.4) 136 (25.8) 0.464 Diabetes 0 22 (62.8) 220 (41.8) 0.012* Downloaded from http://journals.lww.com/ajandrology by BhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hC HT 11 22 (66.6) 319 (60.5) 0.483 Dyslipidemia 6 17 (48.6) 240 (45.4) 0.720 ywCX1AWnYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC1y0abggQZXdgGj2MwlZLeI= on 01/11/2024 Cardiopathy 2 7 (20.0) 99 (18.6) 0.838 Hypogonadism 0 0 (0) 11 (2.1) – Spinal cord injury 0 1 (2.9) 4 (0.7) 0.273 Immunosuppression 0 1 (2.9) 11 (2.8) 1 Previous pelvic surgery 0 8 (22.9) 170 (31.8) 0.267 Previous pelvic radiotherapy 0 0 (0) 26 (4.9) 0.395 Peyronie’s disease 1 6 (17.1) 98 (18.4) 0.854 Contextual Peyronie’s surgery 0 3 (8.6) 39 (7.3) 0.737 Priapism 0 1 (2.9) 11 (0.2) 0.539 Contextual urinary sphincter/urethral sling implantation 0 0 (0) 4 (0.7) – Postoperative antibiotic: amoxicillin clavulanate 52 22 (73.3) 277 (56.5) 0.071 Postoperative antibiotic: ciprofloxacin 52 5 (16.7) 191 (39.0) 0.014* Operation time 0 95.3±31.7 85.5±28.9 0.032* LVI 2 10 (28.6) 105 (19.7) 0.204 r/g‑c 3IPP 5 20 (58.8) 205 (38.5) 0.019* Redo surgery 0 8 (22.9) 57 (10.7) 0.048* Drainage 11 16 (47.1) 264 (49.9) 0.782 * P value according to the Mann‑Whitney U test or the Fisher’s exact test as indicated. EPI: early prosthetic infection; MD: missing data; s.d.: standard deviation; ASA: American Society of Anesthesiologists; TS: tobacco smoker; BMI: body mass index; HT: hypertension; LVI: surgeon in training/low‑volume implanter; r/g‑c 3IPP: rifampin/gentamicin‑coated 3‑piece inflatable penile prosthesis; exTS: former tobacco smoker; –: not available Table 5: Logistic regression model has a major impact on the rate of postoperative complication, might Predictors Estimate s.e. OR (95% CI) P be the major drive for patient’s satisfaction. Infection of the prosthesis is among the most feared complication Age −0.031 0.019 0.969 (0.93–1.01) 0.0966# Diabetes 0.825 0.368 2.281 (1.12–4.81) 0.0252* after PP surgery. Infectious complications are associated with Reintervention 1.063 0.442 2.895 (1.15–6.66) 0.0163* significant impact on the economy of the healthcare system, with the cost of treatments usually exceeding the cost of the original prosthetic r/g‑c 3IPP 0.867 0.366 2.380 (1.17–4.97) 0.0177* * Statistical significance P<0.05. #Statistical significance P<0.1. Dependent variable: early implant by more than six-fold.15 prosthetic infection. Intercept is omitted. CI: confidence interval; OR: odds ratio; r/g‑c PP infections vary in timing, clinical presentation, and underlying 3IPP: rifampin/gentamicin‑coated 3‑piece inflatable penile prosthesis; s.e.: standard error microbiology. EPI, which is supposed to originate from direct infection of the device during surgery, usually emerges several weeks after prosthetic infections. We showed that PP implantation was an effective surgery (ranging from 6 weeks to 8 weeks).16,17 treatment option for men with ED with low risk of complications Diabetes mellitus is the most investigated risk factor for EPI. and high patient and partner satisfaction. Of clinical importance, our Diabetes is a known cause of multiorgan dysfunction often affecting results confirmed previous studies showing that diabetes and secondary end arteries in organs such as the penis. While diabetes is recognized surgeries are risk factors for EPI. Of clinical importance, this is the to impact postoperative wound healing and to increase the risk of first report that shows how different systemic and prosthetic-related infections, the physiopathology of this process is complex and likely strategies can significantly impact the infectious outcome of PPI multifactorial. In particular, decreased fibroblast proliferation and implantation. impaired neutrophil function have been found to play a significant Patient satisfaction with PP is a complex and multifactorial issue role in diabetes-related complications.18,19 Data from the literature are that varies between the occurrence of postoperative complications, controversial. While the AUA Guidelines state that there is no relevant cosmetic outcome, ease of use, and partner acceptance. Numerous evidence that diabetic men are at higher risk of prosthesis infection than studies have reported high rates of patient satisfaction after PP men from the general ED population,17 the EAU Guidelines support the implantation (up to 80%).11,12 In terms of implant, previous studies have role of diabetes as a typical risk factor for men undergoing PP.16 Mulcahy shown a higher satisfaction rate for malleable devices as compared to and Carson20 found an increased rate of postoperative infections in 3IPP (86.8% vs 76%, and 54% vs 71%, respectively).13,14 On the contrary, diabetic vs nondiabetic men. In addition, a recent review reported that we showed a higher overall satisfaction in patients who underwent 3IPP glucose control had a significant impact on PP infection.21 In details, as compared to other devices. This difference may be explained by the a glycated hemoglobin (HbA1c) threshold level of 8.5% was found to different populations analyzed. Our cohort mainly included men who be associated with an increased postoperative risk of IPP infection.21 underwent 3IPP placement, while in other series, malleable devices Our results corroborate these findings since we showed that a history were more frequently used. It is likely that the surgical expertise, which of diabetes mellitus was associated with twice higher risk of EPI. Asian Journal of Andrology Penile prosthesis: outcomes and infection predictors F Palmisano et al 37 Downloaded from http://journals.lww.com/ajandrology by BhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hC ywCX1AWnYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC1y0abggQZXdgGj2MwlZLeI= on 01/11/2024 a b Figure 1: (a) Nomogram for predicting EPI onset after penile prosthesis implantation. The value for each factor (diabetes, first implant, r/g-c 3IPP) corresponds to points vertically above on the top scale. Point values are added together to determine the total points, which is directly connected to the odds of having EPI after surgery. Instructions for readers: in diabetic patients, draw a line from “Diabetes” axis straight upward to the point axis to determine how many points he receives for this comorbidity. Repeat the process for each additional variable. Sum the points for each of the predictors. Locate the final sum on the total point axis. Draw a line straight down to find the patient’s probability of EPI. (b) Clinical example. Redo surgery in diabetic patient who has been scheduled for a malleable prosthesis implant: draw a vertical line (in red) for each of the variables of your patient (diabetes “Yes” = 82 points; first implant “NO” = 100 points, r/g-c 3IPP “NO” = 0 points); then you sum up the three values you read on the Points scale (82 + 100 + 0 = 182) to obtain total points. Finally, you draw a vertical line (in green) on the total points scale (182) to read the risk of EPI (0.16; 16%). EPI: early prosthetic infection; r/g-c 3IPP: rifampicin/gentamicin-coated 3-piece inflatable penile prosthesis. Our results showed a three-fold higher risk of infection for redo reported by McAbee et al.28 from an academic training center, where surgeries compared to first implants. This is consistent with previous the rate of infections following PP placement remained low despite literature showing that revision surgery of PP, whether due to involvement of surgeons-in-training. malfunction or infection, is at increased risk of postoperative infection. Similar to previous reports, we did not find any correlation between Reported rates of infection following revision surgery were as high as patient age, history of urinary diversion, history of pelvic radiotherapy, 10.0%–13.3%, as compared to 0.46%–2.00% of virgin cases.22-26 The obesity, and EPI.12,24-33 Furthermore, we failed to find any association increased incidence of postoperative infections following revision between EPI and active smoking status. Despite this, the negative effect surgery is likely multifactorial with scar formation, reduced host of tobacco smoking in the immediate postoperative setting has been resistance, and biofilms playing a pivotal role. well documented.34 Smoking has been associated with an increased risk Longer operative time was also found to be associated with an of infections in patients undergoing surgery, and smoking cessation has increased risk of prosthetic infection.23-27 In this context, although the been associated with a reduced risk. In light of this, physician should impact of surgical experience in reducing postoperative complications encourage smoking cessation in clinical practice. is widely recognized,21 we failed to find a significant association between The management of EPI is challenging. Most of our patients operative time and EPI in our cohort. We believe that the operative were treated with an initial conservative approach. Habous et al.35 time is subordinated to other risk factors related both to the patient and standardized the conservative management of localized infections and to the procedure, i.e., surgical experience, virgin or revision surgery, showed a complete clinical resolution of EPI in 83.8% of cases. Similar and fibrosis of the cavernous bodies. Moreover, our results might be to the results from the current literature, our conservative protocol influenced by the fact that, in our academic center, LVI acting as first has shown a relatively high rate of success, which allowed to avoid PP operators is always assisted by an HVI. This finding is similar to that explantation in more than half of the cases. Asian Journal of Andrology Penile prosthesis: outcomes and infection predictors F Palmisano et al 38 The use of postoperative antibiotics in PP surgery is a matter Finally, since our study is underpowered in detecting interactions of debate. A recent consensus statement of 16 top prosthetic between factors, the proposed nomogram, relying only on main surgeons revealed that oral antibiotics administered anywhere from effects, could be an oversimplification of the actual joint effects of the 5 days to 14 days after surgery was the preferred management, with considered factors. Therefore, larger prospective studies and external a multitude of different oral antibiotics used, including quinolones, validation of our results are warranted. cephalosporins, penicillin, and sulfa drugs.36 Due to its good activity against Staphylococcal infection, excellent CONCLUSIONS Downloaded from http://journals.lww.com/ajandrology by BhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hC oral absorption, and activity against adherent bacteria, ciprofloxacin PP is an effective treatment option for men with ED. This ten-year has been proposed in combination with other antibiotics for the review of PP implantation in a tertiary referral center shows a very low prevention of infections in orthopedic and maxillofacial surgery.37-40 complication rate after surgery and high patient’s satisfaction. Our study ywCX1AWnYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC1y0abggQZXdgGj2MwlZLeI= on 01/11/2024 Of clinical importance, our results showed that the use of ciprofloxacin confirms that diabetes, longer operative time, and secondary surgeries after surgery was associated with reduced risk of EPI. However, further are risk factors for infectious complications following PP placement. large prospective studies are needed to confirm our results. Postoperative ciprofloxacin seems to reduce the risk of EPI, while r/g-c Design improvements in PP, such as antibiotic impregnation/coating, 3IPP appears to have higher risk of EPI without an increased risk of have led to a significant reduction in postoperative prosthesis infection. explant. We propose a data-driven nomogram for the prediction of EPI Since May 2001, Boston Scientific has used InhibiZone®, a device which can be used in clinical practice for better patient’s counseling. impregnation technology with minocycline/rifampin, while since AUTHOR CONTRIBUTIONS August 2002, Coloplast has used a hydrophilic coating which absorbs FP designed the study and drafted the manuscript. LB helped to draft any aqueous antibiotic solution left to surgeon discretion.41,42 Dhabuwala the manuscript and analyze the data. MGS participated in the data et al.43 compared Inhibizone-impregnated AMS penile implants with collection. FP and RI analyzed the data. JSC, AG, AMG, ERC, and EM r/g-c and vancomycin/gentamicin-coated Titan Coloplast penile carried out the critical revision of the manuscript. JSG conceived of implants. Infection rates for Titan Coloplast penile implants coated the study and participated in its design. All authors read and approved with vancomycin/gentamicin and Inhibizone-impregnated AMS penile the final manuscript. implants were 4.4% and 1.3%, respectively (P = 0.05). No significant difference was found in terms of infection rate among r/g-c Titan COMPETING INTERESTS Coloplast implants (81 patients, 0 infection) and the Inhibizone-coated All authors declare no competing interests. AMS implants group (77 patients, 1 case of infection).43 This study did not suggest superiority of r/g-c Titan Coloplast penile implants ACKNOWLEDGMENTS or Inhibizone-impregnated AMS penile implants but strongly The authors acknowledge and thank the employees of the paper archive suggested that all Titan Coloplast penile implants should be coated of the Fundació Puigvert for their hard work and collaboration in the with rifampin/gentamicin solution.43 Although our study showed that preparation of this article. r/g-c 3IPP was associated with an increased risk of EPI, no significant difference was observed in rate of explant. Therefore, a conservative REFERENCES 1 National Institutes of Health. Consensus development conference statement. management of EPI is valuable in preventing further and more Impotence. December 7–9, 1992. Int J Impot Res 1993; 5: 181–284. severe complications. Furthermore, it could be argued that r/g-c and 2 Eardley I. 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