Next Gen vs. Culture for Infected Penile Implants - Clinical Trial

What is the Purpose of this Study?


We are doing this study to learn more about Next Generation Sequencing (NGS) for infections and we want to compare it to standard methods of care in providing information about your infection to doctors.

What is the Condition Being Studied?

Penile Implant Infections

Who Can Participate in the Study?

Key Eligibility

Adults ages 18+ who:
- Were born as a male (have a Y sex chromosone)
- Have a male penile prosthesis
- Do not have any surgical site pain
- Do not have any active, ongoing substance addiction

For more information about who can join this study, please contact the study team at

Age Group

What is Involved?


If you choose to join this study, you will be randomly assigned (like a coin flip) to one of the following groups:
- Arm A: Standard-of-care traditional culture to assess infection
- Arm B: Next Generation Sequencing (NGS) to assess infection

After your group assignment, you will:
- Fill out questionnaires about your symptoms
- Have at least 2 swabs/samples taken of your infection
- Receive an antibiotic treatment (standard of care)
- Have a follow up visit one month after antibiotic treatment and a follow up phone call 6 months later

Study Details

Full Title
Next Generation Sequencing versus Traditional Cultures for Clinically Infected Penile Implants: Impact of Culture Identification on Outcomes
Principal Investigator
Protocol Number
IRB: PRO00109213
Phase N/A
Enrollment Status
Open for Enrollment