Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement

Running, not enrolling · Phase 3

Conditions studied: Erectile Dysfunction, Penile Prosthesis; Complications, Infection or Inflammation

In brief

The purpose of this study is to assess whether intraoperative irrigation with Irrisept is not inferior to irrigation with multiple antibiotics during placement of a first time inflatable penile prosthesis device.

Key facts

Study ID

NCT06489431

Run by

Rush University Medical Center

People needed

200

Starts

2023-12-04

Expected to finish

2027-12-31

Last updated by the study team

2026-07-24

Who can join

Age: any. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Inclusion criteria include all men undergoing penile prosthesis (any manufacturer) implantation (inpatient or outpatient)

You may not qualify if…

• Exclusion criteria include men who are having revision implant surgeries, men who may require intraoperative complex reconstruction including graft for Peyronie's Disease, and transgender males

Where it is running

• Urological Surgeons of Northern California — Mountain View, California, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Uropartners Surgery Center — Des Plaines, Illinois, United States

Full record on ClinicalTrials.gov

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