Penile prosthesis (PP) is one of the main approved therapies for erectile dysfunction (ED). Greater than 50 years of clinical use has led to considerable innovation in PP surgery and patient care.

To summarize the current literature and provide updated clinical evidence to inform healthcare providers on best practices with PP.

A consensus panel was held with leading sexual medicine experts during the 5th International Consultation on Sexual Medicine (ICSM). Relevant peer-reviewed literature was reviewed with focus on research from but not limited to the last 10 years. The quality of each individual study was judged with Oxford levels of evidence (LOE) criteria, but overall LOE were not used as systematic review was not performed. The expert panel generated consensus statements based on the quality of evidence and criteria of GRADE (Grading of Recommendations Assessment, Development and Evaluation).

PP provides excellent outcomes for the treatment of ED. The panel developed 35 recommendations building upon previous recommendations. Nine recommendations (4, 5, 11,13,17, 25, 26, 31, and 32) are retained without change from 2015. Twelve recommendations (1, 2, 3, 7, 9,14,16,19,21, 28, 33, and 34) change syntax to make statements more active or change details. Fourteen recommendations (6, 8, 10, 12, 15, 18, 20, 22, 23, 24, 27, 29, 30, and 35) are novel in this update.

Since the 4th ICSM, new evidence has emerged to guide PP use in modern sexual medicine. While multi-institutional studies are needed to improve outcomes, key challenges remain: reducing infections, enhancing devices, and improving awareness and accessibility. We recommend following 5th ICSM guidelines while emphasizing the importance of clinical judgment and shared decision-making for optimal PP outcomes.

Chlorhexidine gluconate (CHG) (0.05%) has recently been suggested as a dip and irrigation solution at time of inflatable penile prosthesis (IPP) surgery.

This study evaluated infection rates before and after implementing CHG protocol while investigating concurrent risk factors contributing to post operative infections.

A retrospective, consecutive cohort study was performed that included patients who underwent insertion of a Coloplast Titan IPP including both virgin and revision cases between 2021 and 2024. Cases performed from January 2021 to August 2022 utilized rifampin/gentamicin for dip and vancomycin/gentamicin for irrigation (ABX), whereas those from October 2022 to May 2024 utilized CHG for both dip and irrigation. Perioperative risk factors including dip and irrigation solution used at time of surgery were compared between groups.

We defined the incidence of postoperative infection and risk factors associated with infection in each group.

The incidence of infection was significantly higher in the 0.05% CHG group (13/377) compared to the ABX group (0/320) (P < .001). When analyzed separately by subgroup, virgin cases treated with CHG for dip and irrigation demonstrated a significantly higher infection rate (7/315) compared to those in the ABX group (0/280) (P = .012). Similarly, in revision cases, the CHG group also exhibited a significantly higher infection rate (0/40) than the ABX group (6/62) (P = .043).Univariable analysis of the CHG cohort identified three significant risk factors for infection: diabetes mellitus (DM), extended operative time (OP), and revision surgery (P = .003, .001, and < .001, respectively). Multivariable regression analysis revealed that patients with DM had a 5.7-fold increased risk of infection (OR: 5.70, P = .004), while those undergoing revision surgery faced a 5.3-fold higher risk (OR: 5.26, P = .004). Additionally, each minute increase in OP was associated with a 1% higher infection risk (OR: 1.01 per minute, P = .007). These associations remained significant after adjusting for all variables in the model.

Prosthetic surgeons should be cautious about adopting 0.05% CHG for both dip and irrigation in the absence of strong clinical evidence demonstrating its non-inferiority to antibiotic solutions.

This is the first clinical study reporting infection rates after IPP surgery using 0.05% CHG for both dip and irrigation. While retrospective and non-randomized, we present a relatively large sample size of patients.

Our findings identify four risk factors for penile prosthesis infection: usage of the 0.05% CHG solution for dip and irrigation solution of Coloplast hydrophilic-coated devices, DM, revision surgery, and extended OP.

Inflatable penile prosthesis (IPP) insertion is recommended for the treatment of patients with Peyronie's disease (PD) and significant erectile dysfunction (ED); adjunctive procedures can be used for residual curvature after IPP placement.

To assess the management of penile curvature correction in PD patients undergoing IPP procedures within a large multinational, multicenter cohort.

A retrospective analysis was conducted on PD patients treated with IPP by 11 experienced prosthetic surgeons. Demographic, intraoperative, and postoperative data were analyzed to assess the improvement in penile curvature following IPP, including adjunctive correction techniques such as manual modeling, tunica albuginea plication, and grafting.

Curvature correction achieved after IPP placement and adjunctive procedures.

For 499 PD patients treated with IPP, median age was 62.0 [30.0, 91.0] years with mean follow-up of 16.5 (SD = 12.9) months. The mean preoperative curvature was 39.4° (SD = 17.8°), with dorsal curvature being most common. Among our cohort, 17.6% had IPP-only placement, while the majority of 82.4% patients underwent IPP along with adjunctive correction procedures. Specifically, manual modeling (with/without the "scratch" technique) was used in 74.7% of cases, tunica albuginea plication in 4.8%, grafting in 2%, and combined grafting and modeling in 0.8%. Patients who underwent grafting generally had fewer preoperative comorbidities and more severe preoperative curvatures of 60.0° [45.0°, 70.0°]. Grafting also provided the highest median curvature correction of 55.0° [48.8°, 73.8°], (P < .001). Plication achieved a median curvature correction of 40.0° [28.8°, 41.2°], whereas modeling resulted in a median curvature reduction of 26.0° [20.0°, 39.5°], (P < .001).

We observed that grafting, though less frequently used, provided more curvature correction in severe PD cases undergoing IPP.

Large cohort size and multinational participation are strengths, though retrospective design and general variability in surgical techniques are limitations.

Adjunctive techniques, including grafting, plication, and modeling provide options for tailoring curvature correction to disease severity and patient characteristics. Future prospective studies are needed to standardize and evaluate the comparative outcomes of these techniques.

Inflatable penile prosthesis (IPP) is a surgical treatment for erectile dysfunction refractory to medical therapy or for those who desire permanent treatment. Complications like mechanical failure and infection may necessitate reoperation, and patients with certain risk factors remain predisposed to reoperation. We retrospectively analyzed 530 patients undergoing primary IPP implantation at a large, urban, multiethnic hospital with a high volume of IPP implantations. Primary outcomes were reoperation due to any reason and reoperation due to infection. Patient characteristics and intraoperative factors were compared between those requiring reoperation and those not requiring reoperation. Overall, 12.1% of patients underwent reoperation, primarily due to infection, with a median time to reoperation of 4 months. Analysis revealed an increased likelihood of reoperation with Peyronie's disease (OR = 2.47), hemoglobin A1c over 8 (OR = 2.25), active smoking (OR = 2.75), and estimated blood loss (EBL) ≥ 25cc (OR = 2.45). A decreased likelihood of reoperation was observed when Arista™ powder was used intraoperatively (OR = 0.38). Reoperation specifically due to infection was associated with an infrapubic approach (OR = 2.56) and hypertension (OR = 9.12). Our findings confirm smoking and diabetes as risk factors for reoperation, while also providing insights into factors like estimated blood loss and Arista™ powder use. However, long-term survival rates were limited by loss to follow-up. (Clinical trial registration N/A).

Like all surgeries, penile prosthesis implantation (PPI) has the potential for both postoperative complications and suboptimal patient satisfaction. In order to assess risk factors for poor satisfaction, we reviewed patients who had been prospectively recruited in a national multi-institutional registry of penile prostheses procedures (INSIST-ED) from 2014 to 20121. Patient baseline characteristics and postoperative complications were recorded. The primary endpoint of this study was unfavorable outcomes after inflatable PPI, defined as significant postoperative complications (Clavien-Dindo ≥2) and/or Sexuality with Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) scores below the 10th percentile. A total of 256 patients were included in the study. The median age was 60 years (IQR 56-67). The most common cause of erectile dysfunction (ED) was organic (42.2%), followed by pelvic surgery/radiotherapy (39.8%) and Peyronie's disease (18.0%). Postoperative complications were recorded in 9.6%. High-grade complications (Clavien ≥2) occurred in 4.7%. At 1-year follow-up, the median QoLSPP total score was 71 (IQR 65-76). In all, 14.8% of patients were classified as having experienced unfavorable outcomes because of significant postoperative complications and/or QoLSPP scores below the 10th percentile. Logistic regression analysis demonstrated patient age to be non-linearly associated with the risk of experiencing unfavorable outcomes. A U-shaped correlation showed a lower risk for younger and older patients and a higher risk for middle-aged men. ED etiology and surgical volume were not associated with PPI outcomes. Physicians should, therefore, be aware that middle-aged men may be at higher risk of being unsatisfied following PPI compared to both younger and older patients.

Prosthetic urology can substantially enhance the quality of life for patients. However, it is not without challenges. Infections of penile prostheses and artificial urinary sphincters are often difficult to diagnose, manage, and treat. Over time, device improvements, refined surgical methods, better understanding of microbiology, and biofilms in combination with higher sterility standards and protocols, have significantly reduced the rates of infection. Here, the authors offer a comprehensive overview of prosthetic urologic infections and their management in the current era.

Patients with rectal cancer undergoing radical resection often have poor postoperative recovery due to preoperative fasting and water deprivation and the removal of diseased tissue, and have a high risk of complications. Therefore, it is of great significance to apply appropriate rehydration regimens to patients undergoing radical resection of rectal cancer during the perioperative period to improve the postoperative outcomes of patients.

To analyze the effects of goal-directed fluid therapy (GDFT) with a preoperative glucose load regimen on postoperative recovery and complications in patients undergoing radical resection for rectal cancer.

Patients with rectal cancer who underwent radical resection (n = 184) between January 2021 and December 2023 at our hospital were randomly divided into either a control group or an observation group (n = 92 in each group). Both groups received a preoperative glucose load regimen, and routine fluid replacement and GDFT were additionally implements in the control and observation groups, respectively. The operative conditions, blood levels of lactic acid and inflammatory markers, postoperative recovery, cognitive status, hemodynamic indicators, brain oxygen metabolism, and complication rates were compared between the groups.

The colloidal fluid dosage, total infusion, and urine volume, as well as time to first exhaust, time to food intake, and postoperative length of hospital stay, were lower in the observation group (P < 0.05). No significant differences were observed between the two groups in terms of operation time, bleeding volume, crystalloid liquid consumption, time to tracheal extubation, complication rate, heart rate, or mean arterial pressure (P > 0.05). Compared with the control group, in the observation group the lactic acid level was lower immediately after the surgery (P < 0.05); the Mini-Mental State Examination score was higher on postoperative day 3 (P < 0.05); the pulse pressure variability (PPV) was lower at 30 min after pneumoperitoneum (P < 0.05), though the differences in the PPV of the two groups was not significant at the remaining time points (P > 0.05); tumor necrosis factor-α and interleukin-6 levels were lower on postoperative day 3 (P < 0.05); and the left and right regional cerebral oxygen saturation was higher immediately after the surgery and 30 min after pneumoperitoneum (P < 0.05).

GDFT combined with the preoperative glucose load regimen is a safe and effective treatment strategy for improving postoperative recovery and risk of complications in patients with rectal cancer undergoing radical resection.

Inflatable Penile Prostheses (IPP) implantation is a surgical treatment for patients desiring definitive treatment for erectile dysfunction. While this procedure has proven to be effective, it also carries its own set of unique risks that need to be carefully considered. The article reviews the current understanding of complications associated with penile prosthetic surgery and provides strategies to mitigate these adverse events. This article covers various aspects of IPP implantation, including the risks of infection, bleeding, injury to nearby structures, glans ischemia, and device malfunction. It also discusses the importance of careful preoperative screening to identify risk factors and the implementation of infection reduction strategies such as antimicrobial prophylaxis, skin prep, and operative techniques. In addition, it emphasizes the need for postoperative vigilance and prompt management of any complications that may arise. Overall, the article provides a comprehensive overview of the risks and strategies for mitigating complications associated with IPP implantation. Our recommendations are given based on the current consensus in the field and highlight the importance of careful planning, attention to detail, and effective communication between healthcare providers and patients. Despite the potential risks, this review underscores the fact that complications following penile prosthesis implantation are relatively rare.

To evaluate outcomes of inflatable-penile-prosthesis (IPP) implantation after radical-cystectomy compared with other etiologies of erectile dysfunction.

All inflatable penile prostheses within the past 20 years in a large regional health system were reviewed, and erectile dysfunction etiology was determined as radical-cystectomy, radical-prostatectomy, or organic/other ED. Cohorts were generated by 1:3 propensity score match using age, body mass index, and diabetes status. Baseline demographics and relevant comorbidities were evaluated. Clavien-Dindo complications, grade, and reoperation were assessed. Multivariable logarithmic regression was used to identify the predictors of 90-day complications following IPP implantation. Log-rank analysis was used to assess the time-to-reoperation after IPP implantation in patients with a history of cystectomy compared with non-cystectomy etiologies.

Of 2600 patients, 231 subjects were included in the study. Comparing patients undergoing IPP for cystectomy vs. pooled non-cystectomy indications, those who underwent radical-cystectomy had a higher overall complication rate(24% vs. 9%, p=0.02). Clavien-Dindo complication grades did not differ across groups. Reoperation was significantly more common following cystectomy (cystectomy: 21% vs. non-cystectomy: 7%, p=0.01), however time to reoperation did not differ significantly by indication (cystectomy: 8 years vs non-cystectomy: 10 years, p=0.09). Among cystectomy patients, 85% of reoperations were due to mechanical failure.

Compared to other erectile dysfunction etiologies, patients undergoing IPP with a history of cystectomy have an increased risk of complications within 90-days of implantation and need for surgical device revision, but no greater risk for high-grade complications. Overall IPP remains a valid treatment option after cystectomy.

Despite significant scientific advances in the modern three-piece inflatable penile prosthesis implant surgery, it is not without surgical risks and can carry additional cosmetic and psychosocial consequences in poorly selected and consented individuals. To address this problem, an international group of key opinion leaders and high-volume prosthetic surgeons reviewed the current guidelines and clinical evidence, discussed their experiences, and formed a consensus regarding inflatable penile prosthesis surgery. The findings of this consensus panel were presented at the 17th biennial Asia Pacific Society of Sexual Medicine scientific meeting. The experts concluded that proper patient selection, informed consent and strict adherence to safe surgical principles are important to optimize clinical outcomes. Furthermore, most intraoperative complications, if recognized, can be addressed intraoperatively to enable placement of the device at the time of initial surgery. Men with significant corporal fibrosis due to Peyronie's disease, prior prosthesis explantation and priapism, and men who have undergone construction of a neophallus, as well as men who receive concurrent continence surgery, are complex cases requiring additional care and advanced techniques to obtain optimal surgical outcomes. Variability in patient care - in terms of postoperative antibiotic use, pain management, scrotal care, and cycling of the penile prosthesis implant - must be reduced to enable optimization and assessment of outcomes across patient groups.

Since their initial release in the 1970s, modern penile prostheses have been subjected to continuous improvement with respect to both device engineering and surgical technique. Proper implantation begins with appropriate patient selection and counseling; these are essential elements to optimize results and set expectations postoperatively. An evidence-based protocol for the prevention of infections is essential. A pain management protocol should be initiated even before surgery. Strict adherence to recommended intraoperative techniques minimizes the risk complications; when complications occur, a step-by-step process for management improves odds of resolution. Safe techniques to increase the perceived or actual penile length postimplant can markedly improve patient satisfaction. Postoperatively, the surgeon and the patient should follow strict evidence-based instructions to optimize the overall outcomes of penile prosthesis surgery.

The association between elevated hemoglobin A1c (HbA1c) levels and the risk of postoperative infection after penile prosthesis surgery remains controversial.

To examine the association between HbA1c levels and penile implant infections in men undergoing inflatable penile prosthesis (IPP) surgery for erectile dysfunction using a large insurance claims database.

This was a retrospective review using Optum's de-identified Clinformatics Data Mart Database. Male subjects 18 years and older with available laboratory data undergoing IPP insertion between 2003 and 2018 were included. Administrative diagnosis and procedural codes were used to assess subsequent penile implant revision surgery status for either infectious or noninfectious causes. Associated conditions were controlled for such as smoking status, hyperlipidemia, hypertension, obesity status, and Peyronie's disease.

The main outcomes were risk of revision for infection and time to revision.

A total of 2,363 individuals underwent initial IPP insertion and had available HbA1c data with a mean HbA1c of 6.9%. The overall IPP infection revision rate was 3.9% and the highest rate of 12.1% was seen in the highest HbA1c group (>10%). After adjusting for demographic and health factors, a higher HbA1c level was associated with a higher risk of revision for infection, with every 1 point increase in HbA1c conferring an increased risk of infection requiring revision by 29% (95% CI 17-42%). When infections did occur, they happened sooner in men with HbA1c > 10.0% with an average of 1.3 months vs 3.5 months in the HbA1c < 6.0% group.

These findings provide insight into the potential relationship between HbA1c levels and postoperative risk of infection after penile prosthesis surgery and may aid in clinical decision-making.

Strengths include the large sample size, length of data coverage, and real-world analysis of surgeries done across the United States. Limitations include the reliance on insurance claims data, the retrospective study design, and lack of additional relevant clinical variables that may impact infection rates.

While the overall risk of penile prosthesis infection remains modest, the current report notes an increased risk of infection for diabetic men with poor glycemic control. Chen T, Li S, Eisenberg ML. The Association Between Hemoglobin A1c Levels and Inflatable Penile Prosthesis Infection: Analysis of US Insurance Claims Data. J Sex Med 2021;18:1104-1109.

Diabetes mellitus is associated with increased risk of erectile dysfunction. Penile prosthesis implantation is an efficient therapeutic option for erectile dysfunction, but not without risk, as infection remains a prominent concern. This study investigates diabetes mellitus as a risk factor for penile prosthesis implantation infection and the relationship between haemoglobinA1c levels and infection rates. All diabetic patients with erectile dysfunction who underwent penile prosthesis implantation surgery between January 2012 and November 2019 at Hamad Medical Corporation, Qatar, were included in this retrospective observational study. A total of 599 diabetic patients with erectile dysfunction had penile prosthesis implantation. Mean age was 59.69 ± 31.19. Penile prosthesis implantation infection rate was 0.83% (5/599), while the mean haemoglobinA1c level was 7.58 ± 1.45 mmol/l (range: 4.1-12.6). A comparison between diabetic patients with penile prosthesis implantation infection and those without infection revealed no significant difference in the level of haemoglobinA1c between the two groups with mean haemoglobinA1c in patients with infected implants 7.14 and 7.59 for noninfected (p = 0.491). Limitations include retrospective single-centre design and low-infection rates reducing sample number. Penile prosthesis implantation infection rate in a large series of diabetic patients was low with no significant association between haemoglobinA1c level and penile prosthesis implantation infection observed.

The role of glycemic control in predicting implant infection and other surgical complications is debatable. This study aimed to assess the potential correlation between fasting blood sugar (FBS) levels prior to penile prosthesis surgery (PPS) and the surgical outcomes.

A retrospective study from data collected prospectively in 2015 in a single center. Patients who underwent penile implant procedures were included. Exclusion criteria were if surgery done by low-volume implanter, patients who required revision surgery or not diagnosed with diabetes mellitus. Management was standardized to all patients.

All complications whether minor or major were documented up to three years. One year after the surgery a Likert scale questionnaire was completed by the patients. In total, 218 patients completed the study at last follow-up. Complications rate was 6.25%. The rate of infection requiring explantation was 3.8%. 0.9% of patients had a superficial infection managed successfully with conservative management. 0.9% had erosion and 0.9% had mechanical failure. There was no statistically significant difference in FBS or glycated hemoglobin (HbA1c) levels in patients with postoperative complications compared to patients with satisfactory postoperative course. FBS level on the day of surgery was within 20 mg/dL (1.11 mmol/L) of the expected range based on HbA1c measurement in 62 patients (28.44%), while in 146 patients (66.98%) the FBS was not within 20 mg/dl (1.11 mmol/L) of the expected range based on preoperative HbA1c level.

FBS levels on the day of surgery are not correlated with HbA1c levels and PPS outcomes.

Inflatable penile prosthesis (IPP) infections are undeniably devastating for patient and surgeon alike. While less common in this modern era, the landscape of prosthesis infection is shifting. Continued examination of risk factors for infection and re-evaluation of common practices remain critical should we aim to advance the field. Quality research on this topic is limited by several factors, among which small sample size and lack of coordinated effort pose the most precarious of challenges. Nonetheless, careful analysis of available data in conjuncture with judicious utilization of established research from other prosthetic fields can help us better grasp the issue at hand. In this review, we aim to do exactly that-to examine available evidence in an effort to discern fact from fiction. In this first part of the three part series, we aim to summarize our understanding of the pathogenesis behind prosthesis infections, explore known preoperative risk factors, and discuss intraoperative considerations for infection prevention. In the second part of this series, we will examine the game changing effect of infection retardant implant coatings. Part three of the series details postoperative prevention strategies, reviews salvage techniques, and discusses additional key considerations.