Methods and early findings from a study comparing next-generation sequencing versus traditional cultures for penile implants concerning for low-grade infection

Sep 30, 2026

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Microbial culture remains the standard approach for selecting therapeutic antibiotics in infections associated with inflatable penile prostheses (IPPs). Next-generation sequencing (NGS) of DNA offers analytical advantages for biofilm composition and the relative abundance of specific microorganisms. This study evaluates whether NGS compared with microbial culture can better guide management, antibiotic choice, and device survival. Early results from randomized arms examined infected device microbiology, resistance, and clinical presentation, including device removal outcomes within the first 7 days.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages7

Reading Time18 min

AccessFree to download

Abstract

Introduction

Infection burden and clinical impact

Current prevention strategies and limitations

Study methods and early findings

Randomized analytic arms

Device survival and clinical presentation

Methods and early findings from a study comparing next-generation sequencing versus traditional cultures for penile implants concerning for low-grade infection Gerard D. Henry1, Niccole Diaz2, Caleb D. Phillips2, Aaron C. Lentz3, Paul Perito4, Richard Natale5, Nelson Bennett6, Andrew R. Stuart1, Caroline J. Henry1, Paul H. Chung7 1Willis-Knighton Advanced Urology Department, Willis-Knighton Bossier Health System, Bossier City, LA, USA; 2Clinical Research Department, MicroGenDX Diagnostics, Orlando, FL, USA; 3Department of Urology, Duke University School of Medicine, Raleigh, NC, USA; 4Perito Urology, Coral Gables, FL, USA; 5Carolina Urology Partners, Concord, NC, USA; 6Department of Urology, Northwestern University Medicine, Chicago, IL, USA; 7Department of Urology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA Correspondence to: Gerard D. Henry, MD. Willis-Knighton Advanced Urology Department, Willis-Knighton Bossier Health System, 2300 Hospital Drive Suite 460, Bossier City, LA 71111, USA. Email: [gdhenry@hotmail.com](gdhenry@hotmail.com). Abstract: Microbial culture is the current standard of care to choose therapeutic antibiotics for infection occurring with inflatable penile prostheses (IPPs) . However, next-generation sequencing (NGS) of DNA has proven beneficial for analysis of biofilm composition and relative abundance of specific microorganisms. The main goal of this study is to evaluate whether NGS compared to microbial culture can better guide the management and antibiotic selection and device survival rates. We hypothesize that identifying microbial composition with NGS, as compared with traditional culture, will lead to better therapeutic strategies resulting in improved patient outcomes and device survival. In this present manuscript, we describe the overall study methodology and analyze device survival rates, classify clinical presentations of IPP infections, and determine infected implant microbial composition and antibiotic resistance among an early patient cohort. These early results included 18-to 80-year-old consecutive male patients who received antimicrobial treatment without surgical replacement for at least 7 days since identification of infected IPPs. Subjects were randomized into two analytic arms: traditional culture and NGS. Throughout the study, investigators and patients completed questionnaires to provide data for comparison. To date, of the 9 patients enrolled in the study, 6 eventually underwent device removal due to worsening infection within 7 days of initiating empiric antibiotic treatment. Six patients were seen in a clinic setting, while 3 were seen in the hospital/emergency department: 7 implants were primary, while 2 were secondary. All subjects received a Coloplast IPP but had differing reservoirs and reservoir locations. In cases where penile shaft tenderness was present, the implanted IPP was more often removed within 7 days. In contrast, when no tenderness was reported, the device remained viable for at least 10 days. As of this report, 11 active sites have participated in the study, with ongoing patient enrollment aimed at reaching sufficient sample sizes for statistical comparison. Penile shaft tenderness was a common presentation among patients whose early antibiotic treatment for IPP infection failed. Recruitment of additional patients to this prospective, randomized controlled trial will help to identify favorable presentations of IPP infection. Additional data will allow comparison of implantation outcomes between NGS and traditional culture. Keywords: Inflatable penile prosthesis (IPP); next-generation sequencing (NGS); microbiome; traditional microbial culture; infection Submitted Jan 22, 2025. Accepted for publication Nov 20, 2025. Published online Dec 24, 2025. doi: 10.21037/tau-2025-57 View this article at: [https://dx.doi.org/10.21037/tau-2025-57](https://dx.doi.org/10.21037/tau-2025-57) © AME Publishing Comp

FAQs

What is the purpose of comparing NGS with traditional microbial culture in this IPP infection study?

To determine whether NGS can better guide management, antibiotic selection, and device survival compared with traditional culture, using early cohort outcomes.

How were participants allocated for analysis in the study?

Subjects were randomized into two analytic arms: traditional culture and NGS, with investigators and patients completing questionnaires for comparative data.

What early clinical pattern was associated with early antibiotic treatment failure?

Penile shaft tenderness was common among patients whose early antibiotic treatment for IPP infection failed, with more device removals occurring within 7 days.

Sep 30, 2026

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