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| Name | Class |
|---|---|
| Azienda Ospedaliero, Universitaria Pisana | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closed-System Bladder Irrigation Device | Experimental | 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. |
|
| Standard Bladder Irrigation | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of bacteriuria | 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. | Daily from 48 to 72 hours after surgery (three consecutive postoperative days) |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare worker exposure to biological fluids | Occurrence of leakage or contact with biological fluids during bladder irrigation procedures, recorded using a structured checklist completed by healthcare professionals. | From surgery until hospital discharge, up to 5 days |
| Usability of the bladder irrigation device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicola Pagnucci, RN, MSN, PhD | University of Pisa | Study Chair |
| Lorenzo Sebastio, RN, MSN | Pisa University Hospital | Study Director |
| Salvatore Pagliaro, RN, MSN, PhD | Pisa University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero Universitaria Pisana | Pisa | Tuscany | 56100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20156062 | Background | Gould 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. | |
| 32791923 | Result |
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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.
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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.
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| 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. |
|
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. |
| At the end of postoperative bladder irrigation, up to 5 days after surgery |
| Yoon 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. |
| 20238325 | Result | Hagen 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. |
| 35135337 | Result | Management 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. |
| 28867449 | Result | Kolawole 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. |
| 28262925 | Result | Shepherd 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. |
| 8655831 | Result | Getliffe 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. |
| 36273485 | Result | GBD 2019 Benign Prostatic Hyperplasia Collaborators. The global, regional, and national burden of benign prostatic hyperplasia in 204 countries and territories from 2000 to 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Healthy Longev. 2022 Nov;3(11):e754-e776. doi: 10.1016/S2666-7568(22)00213-6. Epub 2022 Oct 20. |
| Result | Freier, H., Gerhards, L. M., Sondern, D., Schwenke, S., & Thielsch, M. (2022). Usability and User Experience of Medical Devices - Insights from Laypersons and Healthcare Professionals Proceedings of Mensch und Computer 2022, Darmstadt, Germany. https://doi.org/10.1145/3543758.3547534 |
| 38714379 | Result | Kranz J, Bartoletti R, Bruyere F, Cai T, Geerlings S, Koves B, Schubert S, Pilatz A, Veeratterapillay R, Wagenlehner FME, Bausch K, Devlies W, Horvath J, Leitner L, Mantica G, Mezei T, Smith EJ, Bonkat G. European Association of Urology Guidelines on Urological Infections: Summary of the 2024 Guidelines. Eur Urol. 2024 Jul;86(1):27-41. doi: 10.1016/j.eururo.2024.03.035. Epub 2024 May 6. |
| 32624002 | Result | Atkins L, Sallis A, Chadborn T, Shaw K, Schneider A, Hopkins S, Bunten A, Michie S, Lorencatto F. Reducing catheter-associated urinary tract infections: a systematic review of barriers and facilitators and strategic behavioural analysis of interventions. Implement Sci. 2020 Jul 6;15(1):44. doi: 10.1186/s13012-020-01001-2. |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D001749 | Urinary Bladder Neoplasms |
| D055499 | Catheter-Related Infections |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D007239 | Infections |
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