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NCT Number: NCT07510685

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

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.

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Key information

Conditions

Urinary Tract Infection Bacterial Benign Prostatic Hyperplasia Bladder Cancer Catheter-Related Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Infections Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Hyperplasia Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, 56100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Closed-System Bladder Irrigation Flow Switch Device

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.

Standard Bladder Irrigation

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Collaborators

  • Azienda Ospedaliero, Universitaria Pisana

Registry information

Official study title

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)

Acronym: IRIS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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