Infection following inflatable penile prosthesis placement: a real-world comparison of device selection and patient characteristics

Introduction

Background

Penile prostheses are a safe and effective treatment for erectile dysfunction (ED) in men who have not responded to, are intolerant of, or prefer not to use non-surgical therapies (1-3). A recent study has shown that the use of penile prostheses to treat ED has increased in the US and globally (4).

Rationale and knowledge gap

Despite their benefits, post-operative device infections remain a significant concern following inflatable penile prosthesis (IPP) placement (5,6). Several patient risk factors have been associated with IPP infection, including smoking, diabetes, spinal cord injury, and immunocompromised status (5-9). Multiple strategies for reducing the likelihood of infection have been explored, including hair removal, surgical techniques to minimize wound exposure, and avoiding contact between the prosthesis and the patient’s skin (6,10).

Furthermore, intrinsic changes have been made to device development including the use of antibiotic-impregnated or hydrophilic prostheses, both of which have been recognized as contributing to a reduced risk of post-operative infection (6,8,10).

Objective

Therefore, this study sought to compare the infection rate following implantation of an IPP in patients treated with AMS 700™ or Titan^®. We present this article in accordance with the STROBE reporting checklist (available at https://tau.amegroups.com/article/view/10.21037/tau-2025-267/rc).

Methods

Study type, data source, and patient population

This retrospective administrative data analysis used the Premier PINC AI™ Healthcare Database, a proprietary database managed by Premier Inc. (Charlotte, NC, USA). This nationally representative database includes information on hospital-based inpatient stays and outpatient visits to emergency departments, ambulatory surgery centers, and alternate care sites. The database includes more than 1.4 billion outpatient visits across over 1,400 hospitals in the United States (11), and provides device clinical variables including comorbidities, procedural context, and facility characteristics. It allows for longitudinal tracking of patient data as long as they continue to visit a Premier facility. This dataset was specifically chosen for its ability to identify the device used in each procedure and to capture a diverse range of institutions and surgical practices.

The study included adult (aged ≥18 years) male patients who underwent IPP insertion [Current Procedural Terminology (CPT^®) code 54405] between 2016 and 2022. The study period was selected to allow for adequate sample size and capture of contemporary surgical practices, within the bounds of available data. The IPP device model used was either AMS 700 with a “Momentary Squeeze” (MS) pump, with or without InhibiZone™, or Titan. Individuals who had a prior IPP insertion within one year of the index IPP procedure were excluded. The twelve months prior to the index IPP procedure was used as the baseline period. Patients were followed until December 31, 2022.

This retrospective study used de-identified data and did not involve human participants; therefore, it was reviewed and determined to be exempt from institutional review board (IRB) oversight in accordance with 45 CFR 46.104(d) (4). The study was conducted with support from Boston Scientific (Marlborough, MA, USA). The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments.

Outcomes and measures

The primary outcome of interest was the incidence of infection events post-IPP placement. IPP infection episodes were identified using the presence of: (I) International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) code, T83.61XA; or (II) CPT code: 54411; or (III) CPT code 54406 in combination with ICD-10-CM code T83.61XA; or (IV) CPT code 54410 in combination with ICD-10-CM code T83.61XA. Patient demographics included age, race, and geographic region of residence. Baseline risk factors were identified using ICD-10-CM and CPT codes, based on variables that have been previously published and studied in the literature (6,8,12,13). These included age ≥75 years, current smoking status, concomitant circumcision, and the presence of several conditions, including human immunodeficiency virus (HIV), diabetes type 1 and 2 (with and without comorbidities), previous pelvic radiation, urinary diversion, spinal cord injury, obesity, and Peyronie’s disease for their potential impact on surgical complexity and post-operative complications. Comorbidity burden was assessed using the Charlson Comorbidity Index (CCI) (14) using information from the baseline period.

Statistical analyses

Patient characteristics, including the presence of known risk factors for IPP infection, were compared using means and standard deviations (SDs) or counts and percentages. Statistical significance of the comparison between groups was determined using t-tests or chi-squared tests. Kaplan-Meier methods were used to estimate cumulative incidence of IPP infection, and Cox proportional hazards regression was used to analyze the time to IPP infection, adjusted for age, CCI, race, region, teaching status of hospital (academic vs. not), year of IPP surgery, and the presence of known IPP infection risk factors. Multiple adjusted models were explored by varying how IPP infection risk factors were included in the model. All analyses were performed using the Instant Health Data software (Panalgo, Boston, MA, USA) and Stata 18.0 (StataCorp LLC, College Station, TX, USA).

Results

Study population

A total of 18,475 individuals had evidence of an IPP insertion between 2016 and 2022; of those, 3,636 received AMS 700 and 2,830 Titan, comprising the study sample. The rest of the procedures had not been labeled properly or at all and hence needed to be excluded from the comparative analysis. The mean age was similar between those receiving the AMS 700 and the Titan: 64 years (63.6±9.2 vs. 63.7±9.2 years, P=0.70). Patients receiving AMS 700 had a significantly higher mean CCI (0.46 vs. 0.24, P<0.001). A higher proportion of Caucasian patients (74.4% vs. 51.1%, P<0.001) and patients residing in the southern region of the United States (67.6% vs. 50.6%, P<0.001) received AMS 700 compared to Titan (Table 1).

Regarding IPP infection risk factors, a significantly higher proportion of patients with type 2 diabetes (10.7% vs. 6.0%, P<0.001), obesity (5.6% vs. 2.9%, P<0.001), and Peyronie’s disease (2.3% vs. 1.6%, P=0.04) were observed in the AMS 700 vs. Titan group; those in the AMS 700 group were also more likely to be smokers (1.0% vs. 0.2%, P<0.001, Table 2). In total, 26.9% of AMS 700 patients had at least one IPP infection risk factor compared to 19.2% of Titan patients (P<0.001, Table 2). While 73.1% of AMS 700 patients had no risk factor, the rate was 80.8% for Titan patients (P<0.001, Table 2) The mean number of risk factors was 0.37 for AMS 700 patients vs. 0.24 for Titan patients (P<0.001, table not shown). The largest number of risk factors in either group was four.

IPP infection rate

The infection rate at 180 days post-IPP placement was 1.8% for AMS 700 and 2.9% for Titan. At a median follow-up of 3 years, the infection rate was 2.5% for AMS 700 and 3.3% for Titan patients (Figure 1). Unadjusted Cox regression estimated the hazard ratio (HR) associated with the AMS 700 (vs. Titan) was 0.74 [95% confidence interval (CI): 0.56–0.996, P=0.047, Table 3].

Figure 1 Cumulative incidence of infection post IPP implantation. HR is from an unadjusted Cox regression: AMS 700 vs. Titan. CI, confidence interval; HR, hazard ratio; IPP, inflatable penile prosthesis.

Adjusted Cox regression

When adjusted for the existence of at least one IPP infection risk factor, the estimated HR associated with the AMS 700 was 0.66 (95% CI: 0.47–0.92, P=0.02, Table 3); similar results were obtained when adjusting for the number of IPP infection risk factors. When each individual risk factor was included as a covariate in the model, the estimated HR associated with the AMS 700 was 0.67 (95% CI: 0.48–0.93, P=0.02, Table 3). Only two of the IPP infection risk factors produced significantly higher incidence of IPP infection: spinal cord injury (HR =5.56, 95% CI: 1.88–16.5, P=0.002) and obesity (HR =1.99, 95% CI: 1.09–3.65, P=0.03).

Discussion

Key findings

Despite having a higher incidence of risk factors associated with infectious complications, patients receiving AMS 700 experienced significantly lower infection rates in both the short- (180 days) and long-term (3 years) compared to those receiving Titan. This association remained in adjusted analyses that controlled for known risk factors for post-operative infection; that is, a higher adjusted hazard rate of infection occurred in the group with fewer risk factors for reasons not immediately clear.

Comparison with similar research

Besides patient-specific risk factors, other causes for infection have been previously investigated, including surgeon volume and technique (7,9,15-18). Studies have linked lower surgeon volume (as a surrogate for experience with the procedure) to an increased risk of prosthesis-related complications, including infections (6,8), while proper skin preparation and the use of “no touch” techniques can lower infection risk (9,10,19). The current study did not control for surgeon volume, but there is no evidence suggesting a correlation between surgeon experience and prosthesis manufacturer selection. Similarly, there is no indication that surgical approach or technique is preferentially associated with the model of prosthesis used. Information on procedure time is not available in claims data and therefore was not explored in the current study. However, while longer surgical duration has been thought to increase the risk of post-operative infection (7), studies have largely shown mixed results for an association between surgical time and infection rates (20-22).

Explanations of findings

Other perioperative and intraoperative factors may be influencing the difference in outcomes between the two device models, including the utilization of antibiotics both during and after surgery. The dataset used in the current analysis does not allow us to identify differences in the use of perioperative or prophylactic antibiotics, type of irrigation, or post-operative antibiotics used between the two groups. While the American Urological Association (AUA) best practice guidelines suggest the use of an aminoglycoside and vancomycin or a first-/second-generation cephalosporin (23,24), there is growing literature questioning the efficacy of this practice (9,25,26) and significant heterogeneity exists within the prosthetic community on the antibiotics used as prophylaxis and type of irrigation used intraoperatively (27-29). In addition, there is great variability in what surgeons prescribe post-operatively, given the limited evidence of the effectiveness of post-operative antibiotics in preventing infection (17,28,30); including the debated practice of oral antibiotics beyond the recommended 24-hour window (31). Furthermore, differences in irrigation practices during the study period may also have contributed to the observed outcomes. Specifically, Irrisept (chlorhexidine gluconate) became increasingly popular in the United States during this time. However, emerging evidence has suggested that Irrisept may be less effective than traditional antibiotic dip solutions in reducing bacterial contamination (22,32,33), affecting patients using Titan but not patients using AMS 700. These unknowns regarding the two groups in the current study may be contributors to the findings and the authors acknowledge that the absence of data for these confounding variables prevents interpretation to show superiority of one device over the author.

Removal or replacement type of surgery can be associated with increased prosthetic infection risk. This study incorporated a simple study design considering de novo implants where no priori IPP surgery occurred in 1-year lookback. A more complex protocol using a dataset with operation notes denoting revision surgery may shed light on how it may impact the current observations.

An important distinction between the AMS 700 and Titan prostheses is antibiotic delivery. The AMS 700 is available with or without InhibiZone (a combination of rifampin and minocycline hydrochloride) by the manufacturer (34), while the Titan is manufactured with polyvinylpyrrolidone coating and requires surgeons to immerse the prosthesis in an antibiotic of their choice intraoperatively (35). Both manufacturers have demonstrated in clinical studies that antibiotic treatment reduces the risk of infection when compared to prostheses without antibiotic treatments (34-37). However, there has been no direct comparative clinical study evaluating infection rates between different manufacturers in a prospective randomized setting.

Additionally, this study lacked data on the use of InhibiZone with AMS 700 prostheses and the specific antibiotic regimens used for Titan prostheses “dipping”, limiting the ability to assess how variations in antibiotic selection may influence infection risk. Not all antibiotics are equally effective in preventing IPP infections, and some combinations, such as vancomycin with gentamicin have been associated with a higher IPP infection risk than varied antibiotic regimens (26), despite being recommended by the AUA.

Strengths and limitations

A key strength of this study is the use of a large, diverse administrative database with national representation across the United States, enhancing the generalizability of the findings. However, there are significant limitations inherent to retrospective analyses using administrative claims data. For example, claims are subject to coding errors and often lack information regarding the patient or procedure (e.g., specific antibiotic dips used during Titan implantations, AMS 700 devices with or without InhibiZone). This database does not capture intraoperative details such as the use of ectopic reservoirs, penoscrotal vs. infrapubic approach, or operative duration, which may influence infection risk. Additionally, these data may underrepresent outpatient procedures or facilities with different practice patterns, limiting its applicability to all individuals undergoing IPP placement. This analysis does not address other antibiotic/antifungal protocols (pre-operative, peri-operative, and post-operative) nor peri-operative irrigation solution components.

Conclusions

The findings from this study suggest that IPP infection rates may differ by prosthesis model used, with AMS 700 showing a lower infection rate than Titan. These findings have potential implications for clinical practice, highlighting the need for further research to understand how device selection, facility practices, and antibiotic incorporation influence infection risk and long-term prosthesis outcomes. Future studies are needed to validate these findings, especially using clinical registries or operative reports to better assess procedural nuances and establish evidence-based clinical best practices to minimize the risk of infectious complications following IPPs.

Acknowledgments

The authors would like to thank Craig Solid of Solid Research Group for assistance in preparing this manuscript. A part of the data included in this manuscript was previously presented at the American Urological Association (AUA) Conference in 2025 and published as abstract in the Journal of Urology.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://tau.amegroups.com/article/view/10.21037/tau-2025-267/rc

Data Sharing Statement: Available at https://tau.amegroups.com/article/view/10.21037/tau-2025-267/dss

Peer Review File: Available at https://tau.amegroups.com/article/view/10.21037/tau-2025-267/prf

Funding: This work was funded by Boston Scientific.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tau.amegroups.com/article/view/10.21037/tau-2025-267/coif). All authors report funding (provision of study materials and article processing charges) from Boston Scientific. R.S., S.R., and S.T. report employment and equity or stocks with Boston Scientific Corporation. J.L.D reports consulting or advisory relationships with Boston Scientific Corporation and Coloplast in general. W.B. and T.C.H. report consulting or advisory relationships with Boston Scientific Corporation in general. Authors have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. The authors have no other conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. This retrospective study used de-identified data and did not involve human participants; therefore, it was reviewed and determined to be exempt from institutional review board (IRB) oversight in accordance with 45 CFR 46.104(d)(4).

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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