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.
Who Can Participate?
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 urologyresearch@duke.edu.
- 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 urologyresearch@duke.edu.
Age Range
18-110
Sex/Genders
Male (cisgender)
Looking for Healthy Participants
No
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
- 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
Locations
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
Next Generation Sequencing versus Traditional Cultures for Clinically Infected Penile Implants: Impact of Culture Identification on Outcomes
Principal Investigator
Aaron
Lentz
Protocol Number
PRO00109213
Phase
N/A
Enrollment Status
OPEN TO ACCRUAL