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

University of Pisa

Status: Completed

Conditions: Bladder Cancer; Benign Prostatic Hyperplasia; Urinary Tract Infection Bacterial

Treatments: Procedure: Standard Bladder Irrigation; Device: Closed-System Bladder Irrigation Flow Switch Device

Study type: Interventional

Funder types: Other

Identifiers

NCT07510685

IRIS-AOUP-2024

Details and patient eligibility

About

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.

Full description

Urinary tract infections are common complications following urologic surgery, particularly after procedures such as transurethral resection of the prostate (TURP) and transurethral resection of bladder tumor (TURBT). Continuous bladder irrigation is frequently required in the postoperative period to prevent clot formation and maintain catheter patency.

However, manual bladder washouts may require opening the catheter system, which can increase the risk of contamination and urinary tract infection. Closed irrigation systems have been proposed as a strategy to maintain a sterile circuit and reduce infection risk.

This randomized controlled trial evaluates the effectiveness of an innovative closed-system bladder irrigation device designed to allow manual washouts without opening the catheter system.

Patients undergoing TURP or TURBT requiring postoperative bladder irrigation were randomized to either the closed-system device or standard bladder irrigation techniques used in routine clinical practice.

The primary outcome is the incidence of bacteriuria detected through urine culture obtained 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 usability of the device assessed by healthcare professionals through a structured questionnaire.

The study was conducted in the operating rooms of Specialist Surgery and in the Urology Units of Azienda Ospedaliero Universitaria Pisana (AOUP), Italy.

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18 years or older
• Patients undergoing endoscopic urologic surgery (transurethral resection of the prostate or transurethral resection of bladder tumor)
• Patients requiring postoperative continuous bladder irrigation
• Ability to provide written informed consent

Exclusion criteria

• Pre-existing urinary tract infection or bacteriuria prior to surgery
• Known contraindication to urinary catheterization or bladder irrigation
• Patients undergoing emergency surgery
• Inability to provide informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Closed-System Bladder Irrigation Device

Experimental group

Description:

Participants undergoing endoscopic urologic surgery requiring postoperative bladder irrigation receive bladder irrigation using a closed-system irrigation device designed to allow manual washouts without opening the catheter system.

Treatment:

Device: Closed-System Bladder Irrigation Flow Switch Device

Standard Bladder Irrigation

Active Comparator group

Description:

Participants undergoing endoscopic urologic surgery requiring postoperative bladder irrigation receive standard bladder irrigation procedures according to routine clinical practice using a three-way Foley catheter and saline solution.

Treatment:

Procedure: Standard Bladder Irrigation