Next Generation Sequencing Versus Traditional Cultures for Clinically Infected Penile Implants: Impact of Culture Identification on Outcomes

Next Generation Sequencing Versus Traditional Cultures for Clinically Infected Penile Implants: Impact of Culture Identification on Outcomes

Randomized prospective study to evaluate next generation sequencing (NGS) and standard-of-care culture for clinically infected penile implants and to compare outcomes with identification of microbes.

Randomized prospective study to evaluate next generation sequencing (NGS) and standard-of-care culture for clinically infected penile implants and to compare outcomes with identification of microbes. Eligible subjects will undergo a baseline/screening visit at which time the following will be collected: demographics/history/known allergies to antibiotics, symptom scoring questionnaire. Drainage swabs OR needle aspiration will be collected for standard culture and PCR/NGS and empiric antibiotics will start.

Subjects will be randomized into the culture arm or the NGS arm. If randomized to NGS: central ID reviews result according to arm and offers recommendations. Physician will treat based on antibiotic recommendations (based on positive PCR/NGS or positive culture, if negative then empiric treatment will be continued) adjusted for patients contraindications and co-morbidities If randomized to the traditional culture arm: Physician will follow routine local standard of care.

A follow-up visit will occur within 10 days of starting empiric antibiotic therapy to collect symptoms scoring questionnaire. A 2nd and final visit will occur 6 months after baseline to collect similar data to the 1st follow up visit.

Inclusion Criteria:

• Male penile prosthesis patients
• Age range: 18-80
• Within 6 months of penile prosthesis surgery
• At least 1 of the following: Device part stuck to thinning skin, any drainage from the wound site, massive red and swollen genitalia parts, exposed penile prosthesis parts, draining open tract, draining hematoma

Exclusion Criteria:

• Transgender / neophallus
• Not able to communicate or follow up well, or non-compliant
• Less than 18 or more than 80 years old
• Active addiction
• Main issue is implant pain