Collaborative Urological Prosthetics Investigation Directive Research Group — CUPID  

Erectile Dysfunction Clinical Trial

Official title: Collaborative Urological Prosthetics Investigation Directive Research Group

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Erectile Dysfunction

• NCT number: NCT05100654
• Study type: Interventional
• Source: University of Chicago
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: April 22, 2022
• Completion date: January 1, 2025