At a glance
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Closed-System Bladder Irrigation for the Reduction of Urinary Tract Infections After Endoscopic Urologic Surgery With Continuous Bladder Irrigation: A Randomized Controlled Trial (IRIS Study)
In Brief
A clinical study evaluating Closed-System Bladder Irrigation Flow Switch Device and Standard Bladder Irrigation for Urinary Tract Infection Bacterial and 2 related conditions. Completed, enrolled 240 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
A closed-system bladder irrigation flow selector designed to facilitate cystoclysis and manual bladder washouts without opening the urinary catheter circuit. The device allows healthcare professionals to direct the flow between irrigation, syringe washout, and drainage while maintaining a closed sterile system. The device is connected to a three-way Foley catheter, irrigation tubing with saline solution, and a urine drainage bag during postoperative bladder irrigation after endoscopic urologic surgery.
Postoperative bladder irrigation performed according to routine clinical practice using a three-way Foley catheter and saline solution. Manual bladder washouts are performed when clinically indicated using conventional irrigation techniques without the use of a closed-system flow selector device.