Benign Prostatic Hyperplasia, Bladder Cancer, Urinary Tract Infection Bacterial
Conditions
Keywords
Bladder Irrigation, TURP, TURBT, Catheter-Associated Infection, Urologic Surgery, Closed Irrigation System
Brief 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.
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.
Interventions
DEVICEClosed-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.
PROCEDUREStandard 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
University of Pisa
Azienda Ospedaliero, Universitaria Pisana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Masking was not feasible because the intervention involves a visible bladder irrigation device used during routine postoperative care. Healthcare professionals administering the intervention and patients were aware of the assigned procedure.
Intervention model description
This randomized controlled trial uses a parallel-group design. Patients undergoing endoscopic urologic surgery requiring postoperative bladder irrigation are randomly assigned in a 1:1 ratio to either a closed-system bladder irrigation device or standard bladder irrigation procedures. Participants receive only one assigned intervention and are followed during the postoperative period for outcome assessment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of bacteriuria | 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
| Measure | Time frame | Description |
|---|---|---|
| Healthcare worker exposure to biological fluids | 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. |
| Usability of the bladder irrigation device | 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. |
Countries
Italy
Contacts
STUDY_CHAIRNicola Pagnucci, RN, MSN, PhD
University of Pisa
STUDY_DIRECTORLorenzo Sebastio, RN, MSN
Pisa University Hospital
STUDY_DIRECTORSalvatore Pagliaro, RN, MSN, PhD
Pisa University Hospital
Outcome results
None listed