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

NCT07510685 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-04-03

No results posted yet for this study

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.

Conditions

  • Urinary Tract Infection Bacterial
  • Benign Prostatic Hyperplasia
  • Bladder Cancer

Interventions

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.

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.

Sponsors & Collaborators

  • Azienda Ospedaliero, Universitaria Pisana

    collaborator OTHER

  • University of Pisa

    lead OTHER

Principal Investigators

  • Nicola Pagnucci, RN, MSN, PhD · University of Pisa

  • Lorenzo Sebastio, RN, MSN · Pisa University Hospital

  • Salvatore Pagliaro, RN, MSN, PhD · Pisa University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07510685 on ClinicalTrials.gov