Clinical Trial

Closed-System Bladder Irrigation to Reduce Urinary Tract Infections After Endoscopic Urologic Surgery (IRIS Trial)

Study acronym: IRIS
Completed
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Summary
This randomized controlled trial evaluates whether a closed-system bladder irrigation device can reduce the incidence of urinary tract infections in patients undergoing endoscopic urologic surgery. Patients undergoing transurethral resection of the prostate (TURP) or transurethral resection of bladder tumor (TURBT) who require continuous bladder irrigation after surgery are randomly assigned to either a closed-system bladder irrigation device or standard bladder irrigation procedures. The closed-system device allows manual bladder washouts while maintaining the integrity of the catheter system, potentially reducing contamination and the risk of bacteriuria. The primary outcome is the incidence of bacteriuria detected through urine cultures performed starting 48 hours after surgery and repeated daily for three consecutive days. Secondary outcomes include healthcare worker exposure to biological fluids during irrigation procedures and the usability of the irrigation device as perceived by healthcare professionals. The study was conducted at Azienda Ospedaliero Universitaria Pisana (AOUP), Italy.
Trial Details
NCT Number NCT07510685
Lead Sponsor University of Pisa
Collaborators: Azienda Ospedaliero, Universitaria Pisana
Conditions Urinary Tract Infection Bacterial, Benign Prostatic Hyperplasia, Bladder Cancer
Enrollment 240 participants
Start Date 2025-02-01
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-03