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

April 1, 2026 updated by: Nicola Pagnucci, University of Pisa

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Tuscany
      • Pisa, Tuscany, Italy, 56100
        • Azienda Ospedaliero Universitaria Pisana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Closed-System Bladder Irrigation Device
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.
Device: Closed-System Bladder Irrigation Flow Switch Device
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.
Active Comparator: Standard Bladder Irrigation
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.
Procedure: Standard Bladder Irrigation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of bacteriuria
Time Frame: Daily from 48 to 72 hours after surgery (three consecutive postoperative days)
Presence of bacteriuria detected through urine culture collected starting 48 hours after endoscopic urologic surgery and repeated daily for three consecutive postoperative days during bladder irrigation.
Daily from 48 to 72 hours after surgery (three consecutive postoperative days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthcare worker exposure to biological fluids
Time Frame: From surgery until hospital discharge, up to 5 days
Occurrence of leakage or contact with biological fluids during bladder irrigation procedures, recorded using a structured checklist completed by healthcare professionals.
From surgery until hospital discharge, up to 5 days
Usability of the bladder irrigation device
Time Frame: At the end of postoperative bladder irrigation, up to 5 days after surgery
Healthcare professionals' perceived usability and user experience of the bladder irrigation flow selector device assessed using a structured questionnaire composed of multiple items rated on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree), with higher scores indicating better usability.
At the end of postoperative bladder irrigation, up to 5 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pisa

Collaborators

Azienda Ospedaliero, Universitaria Pisana

Investigators

  • Study Chair: Nicola Pagnucci, RN, MSN, PhD, University of Pisa
  • Study Director: Lorenzo Sebastio, RN, MSN, Pisa University Hospital
  • Study Director: Salvatore Pagliaro, RN, MSN, PhD, Pisa University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRIS-AOUP-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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