Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Prostatic Hyperplasia | Benign Prostatic Hyperplasia | ONTOLOGY_EXACT | 0.98 |
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Urinary Tract Infection Bacterial | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Closed-System Bladder Irrigation Flow Switch Device | Device | — | UNRESOLVED |
| Standard Bladder Irrigation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Closed-System Bladder Irrigation Device
- 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.
- interventionNames
- Device: Closed-System Bladder Irrigation Flow Switch Device
- type
- ACTIVE_COMPARATOR
- label
- Standard Bladder Irrigation
- 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.
- interventionNames
- Procedure: Standard Bladder Irrigation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (11)
- BACKGROUNDGould CV, Umscheid CA, Agarwal RK, Kuntz G, Pegues DA; Healthcare Infection Control Practices Advisory Committee. Guideline for prevention of catheter-associated urinary tract infections 2009. Infect Control Hosp Epidemiol. 2010 Apr;31(4):319-26. doi: 10.1086/651091. No abstract available. PMID 20156062
- RESULTYoon HY, Yang HM, Kim CH, Goo YT, Kang MJ, Lee S, Choi YW. Current status of the development of intravesical drug delivery systems for the treatment of bladder cancer. Expert Opin Drug Deliv. 2020 Nov;17(11):1555-1572. doi: 10.1080/17425247.2020.1810016. Epub 2020 Sep 4. PMID 32791923
- RESULTHagen S, Sinclair L, Cross S. Washout policies in long-term indwelling urinary catheterisation in adults. Cochrane Database Syst Rev. 2010 Mar 17;(3):CD004012. doi: 10.1002/14651858.CD004012.pub4. PMID 20238325
- RESULTManagement of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA Guideline PART II-Surgical Evaluation and Treatment. Erratum. J Urol. 2022 Mar;207(3):743. doi: 10.1097/JU.0000000000002388. Epub 2022 Mar 1. No abstract available. PMID 35135337
- RESULTKolawole OM, Lau WM, Mostafid H, Khutoryanskiy VV. Advances in intravesical drug delivery systems to treat bladder cancer. Int J Pharm. 2017 Oct 30;532(1):105-117. doi: 10.1016/j.ijpharm.2017.08.120. Epub 2017 Sep 1. PMID 28867449
- RESULTShepherd AJ, Mackay WG, Hagen S. Washout policies in long-term indwelling urinary catheterisation in adults. Cochrane Database Syst Rev. 2017 Mar 6;3(3):CD004012. doi: 10.1002/14651858.CD004012.pub5. PMID 28262925
- RESULTGetliffe KA. Bladder instillations and bladder washouts in the management of catheterized patients. J Adv Nurs. 1996 Mar;23(3):548-54. doi: 10.1111/j.1365-2648.1996.tb00018.x.