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NCT07510685Completed

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

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)

Source: ClinicalTrials.gov · Last updated 3 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
240 (actual)
First submitted
12 Mar 2026
Start date
1 Feb 2025
Primary completion date
31 Dec 2025
Lead sponsor
University of Pisa
NCT number
NCT07510685

What you commit to

  • Study type: Interventional
  • Participants enrolled: 240
  • From 1 Feb 2025 to the primary completion date, 31 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Pre-existing urinary tract infection or bacteriuria prior to surgery
  • Patients undergoing emergency surgery

Other

  • Known contraindication to urinary catheterization or bladder irrigation
  • Inability to provide informed consent

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Azienda Ospedaliero Universitaria Pisana
Coordinator of this site? Confirm its status
PisaItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.