Urinary Tract Infection BacterialIRISNCT07510685
Closed-System Bladder Irrigation to Reduce Urinary Tract Infections After Endoscopic Urologic Surgery (IRIS Trial)
A study testing Closed-System Bladder Irrigation Flow Switch Device and Standard Bladder Irrigation in people with Urinary Tract Infection Bacterial and Benign Prostatic Hyperplasia, run by University of Pisa at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infection Bacterial, Benign Prostatic Hyperplasia, Bladder Cancer
- What is being tested?
- Closed-System Bladder Irrigation Flow Switch Device and Standard Bladder Irrigation
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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.
Read more
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.
Read the 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.
- Being tested
- Closed-System Bladder Irrigation Flow Switch Device, Standard Bladder Irrigation
- Keywords
- Bladder Irrigation, TURP, TURBT, Catheter-Associated Infection, Urologic Surgery, Closed Irrigation System
- Medical subject headings
- Prostatic Hyperplasia, Urinary Bladder Neoplasms, Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-System Bladder Irrigation Flow Switch DeviceDevice
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.
Standard Bladder IrrigationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Closed-System Bladder Irrigation Flow Switch Device |
| 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. Receives: Procedure: Standard Bladder Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Daily from 48 to 72 hours after surgery (three consecutive postoperative days)
Secondary outcomes (2)
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.
Measured: From surgery until hospital discharge, up to 5 days
Usability of the bladder irrigation 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.
Measured: At the end of postoperative bladder irrigation, up to 5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start1 Feb 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract Infection BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero, Universitaria Pisana
- Responsible party
- Principal investigator, Nicola Pagnucci, University of Pisa
- Investigators
- Nicola Pagnucci, RN, MSN, PhD, Study chair, University of PisaLorenzo Sebastio, RN, MSN, Study director, Pisa University HospitalSalvatore Pagliaro, RN, MSN, PhD, Study director, Pisa University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510685
- Sponsor's protocol ID
- IRIS-AOUP-2024
- Acronym
- IRIS
- Status last verified
- Apr 2026
- First submitted
- 12 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20156062Yoon 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.
PubMed 32791923Hagen 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.
PubMed 20238325Management 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.
PubMed 35135337Kolawole 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.
PubMed 28867449Shepherd 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.
PubMed 28262925Getliffe 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.
PubMed 8655831GBD 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.
PubMed 36273485Freier, 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
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.
PubMed 38714379Atkins 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.
PubMed 32624002
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07510685
- Acronym / sponsor ID
- IRIS / IRIS-AOUP-2024
- Keywords
- Bladder Irrigation, TURP, TURBT, Catheter-Associated Infection, Urologic Surgery, Closed Irrigation System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero, Universitaria Pisana
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Closed-System Bladder Irrigation Device | Experimental | Device: Closed-System Bladder Irrigation Flow Switch DeviceParticipants 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 | Procedure: Standard Bladder IrrigationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed-System Bladder Irrigation Flow Switch DeviceA 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. | Device | Closed-System Bladder Irrigation Device |
| Standard Bladder IrrigationPostoperative 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. | Procedure or surgery | Standard Bladder Irrigation |
Primary outcome
Incidence of bacteriuria
Time frame: 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.
2 secondary outcomes
Healthcare worker exposure to biological fluids
Time frame: From surgery until hospital discharge, up to 5 days
Usability of the bladder irrigation device
Time frame: At the end of postoperative bladder irrigation, up to 5 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Background: PubMed 20156062Gould 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.
- Results publication: PubMed 32791923Yoon 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.
- Results publication: PubMed 20238325Hagen 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.
- Results publication: PubMed 35135337Management 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.
- Results publication: PubMed 28867449Kolawole 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.
- Results publication: PubMed 28262925Shepherd 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.
- Results publication: PubMed 8655831Getliffe 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.
- Results publication: PubMed 36273485GBD 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.
- Results publicationFreier, 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
- Results publication: PubMed 38714379Kranz 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.
- Results publication: PubMed 32624002Atkins 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Pagnucci, RN, MSN, PhD study chair
University of Pisa
Lorenzo Sebastio, RN, MSN study director
Pisa University Hospital
Salvatore Pagliaro, RN, MSN, PhD study director
Pisa University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed-System Bladder Irrigation Flow Switch Device and Standard Bladder Irrigation in people with Urinary Tract Infection Bacterial and Benign Prostatic Hyperplasia, run by University of Pisa at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of bacteriuria (time frame: Daily from 48 to 72 hours after surgery (three consecutive postoperative days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07510685, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.