NCT05100654

Collaborative Urological Prosthetics Investigation Directive Research Group

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: Male
• Age: 35 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if an additional 6 days of oral antibiotics decreases the risk of penile prosthesis infection after implantation.

Detailed description

Erectile dysfunction is a common problem and the incidence increases with age. Penile prosthesis placement for medication refractory erectile dysfunction is well established with high success rates. However, infection remains a dreaded complication with significant patient morbidity requiring device explant. Device innovations such as antibiotic coating and adaptations in technique have led to device infection rate reduction to \~1-3% in the hands of high volume implanters in modern series. The study team will perform a non-inferiority trial of post-operative antibiotic prophylaxis for IPP procedures with InhibiZonetm coated AMS 700 devices to confirm the hypothesis that a prolonged postoperative antibiotic regimen does not influence infection-related outcomes in de-novo IPP placement. The study team will determine potential risk factors for prosthetic infections and which patients would benefit from an extended post-operative oral antibiotic course of 6 days along with other objectives.

Conditions

• Erectile Dysfunction
• Penile Prosthesis Infection

Interventions

Type	Name	Description
DRUG	Doxycycline	Patients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function
DRUG	Ciprofloxacin	Patients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function
DRUG	Augmentin	Patients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function
DRUG	Bactrim	Patients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function

Timeline

• Start date: 2022-04-22
• Primary completion: 2027-12-31
• Completion: 2028-01-01
• First posted: 2021-10-29
• Last updated: 2026-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study