Urinary Tract InfectionsJJ-change-UTINCT06503588
Ureteral Stent Exchange Abstention in Urinary Tract Infections
An observational study of Urinary Tract Infections and Urinary Catheterization, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The Committee of Infectiology of the French Association of Urology (CIAFU) provided, for the first time in 2020, comprehensive guidelines for ureteral stent-associated urinary tract infections (USAUTI) prevention, diagnosis and treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urinary Tract Infections, Urinary Catheterization
- What is being tested?
- Guidelines promoting surgical abstention
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2024to 1 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Groups will be selected from patients attending University Hospital of Nancy meeting the eligibility criteria during the period of inclusion running from January 1, 2018 to May 31, 2020 and from August 1, 2020 to December 31, 2022
Who may be able to join
- All patients with indwelling ureteral catheter
- AND confirmed or probable urinary tract infection
Who cannot join
- Patient's opposition
- History of ileal conduit urinary diversion
- Second or more urinary tract infection during the study period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Nancy university hospital
Nancy, Lorraine, 54000
Benjamin Lefevre, MD PhD, +33383154097, b.lefevre@chru-nancy.fr
About this study
Official title: Ureteral Stent Exchange Abstention in Urinary Tract Infections: a Before-and-after Study to Assess Guidelines' Impact on Patients' Outcomes
The Committee of Infectiology of the French Association of Urology (CIAFU) provided, for the first time in 2020, comprehensive guidelines for ureteral stent-associated urinary tract infections (USAUTI) prevention, diagnosis and treatment. Since evidence lacked in terms of appropriate treatment, guidelines could not support systematic change of US in case of USAUTI.
This study aims to evaluate whether "after guidelines group" patients treated for USAUTI had different occurrence of at least one relapse or recurrence than "before guidelines group".
- Conditions
- Urinary Tract Infections, Urinary Catheterization
- Being tested
- Guidelines promoting surgical abstention
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guidelines promoting surgical abstentionOther
Guidelines promoting surgical abstention
| Study group | Role | What they receive |
|---|---|---|
| Before guidelines | Patients treated for ureteral stent associated urinary tract infection in the University Hospital of Nancy from January 1, 2018 to May 31, 2020 | |
| After guidelines | Patients treated for ureteral stent associated urinary tract infection in the University Hospital of Nancy from August 1, 2020 to December 31, 2022 Receives: Other: Guidelines promoting surgical abstention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse OR recurrence of urinary tract infection
Measured: 1 year
Secondary outcomes (4)
Nephro-urologic complication
Acute kidney injury ; hematuria ; pain ; stent migration or incrustation
Measured: 1 year
Infectious complication
Sepsis or septic shock
Measured: 1 year
In-hospital and 1-year mortality
all cause death
Measured: 1 year
Resort to Watch or Reserve antibiotics
antibiotics' WHO classifcation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Jul 2024
- Primary completion1 Mar 2025
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEFEVRE Benjamin, Central Hospital, Nancy, France
- Investigators
- +33383154097 Lefevre, M.D. PhD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503588
- Sponsor's protocol ID
- 2022PI037
- Acronym
- JJ-change-UTI
- Status last verified
- Aug 2025
- First submitted
- 10 Jul 2024
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ureteral Stent Exchange Abstention in Urinary Tract Infections: a Before-and-after Study to Assess Guidelines' Impact on Patients' Outcomes
- ClinicalTrials.gov ID
- NCT06503588
- Acronym / sponsor ID
- JJ-change-UTI / 2022PI037
- Conditions
- Urinary Tract Infections, Urinary Catheterization
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 16 Jul 2024 (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.
The Committee of Infectiology of the French Association of Urology (CIAFU) provided, for the first time in 2020, comprehensive guidelines for ureteral stent-associated urinary tract infections (USAUTI) prevention, diagnosis and treatment. Since evidence lacked in terms of appropriate treatment, guidelines could not support systematic change of US in case of USAUTI.
This study aims to evaluate whether "after guidelines group" patients treated for USAUTI had different occurrence of at least one relapse or recurrence than "before guidelines group".
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before guidelines | – | –Patients treated for ureteral stent associated urinary tract infection in the University Hospital of Nancy from January 1, 2018 to May 31, 2020 |
| After guidelines | – | Other: Guidelines promoting surgical abstentionPatients treated for ureteral stent associated urinary tract infection in the University Hospital of Nancy from August 1, 2020 to December 31, 2022 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Groups will be selected from patients attending University Hospital of Nancy meeting the eligibility criteria during the period of inclusion running from January 1, 2018 to May 31, 2020 and from August 1, 2020 to December 31, 2022
Key inclusion criteria (2 listed)
- All patients with indwelling ureteral catheter
- AND confirmed or probable urinary tract infection
Key exclusion criteria (3 listed)
- Patient's opposition
- History of ileal conduit urinary diversion
- Second or more urinary tract infection during the study period
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 |
|---|---|---|
| Guidelines promoting surgical abstentionGuidelines promoting surgical abstention | Other | After guidelines |
Primary outcome
Relapse OR recurrence of urinary tract infection
Time frame: 1 year
4 secondary outcomes
Nephro-urologic complication
Time frame: 1 year
Infectious complication
Time frame: 1 year
In-hospital and 1-year mortality
Time frame: 1 year
Resort to Watch or Reserve antibiotics
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- 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.
+33383154097 Lefevre, M.D. PhD principal investigator
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections and Urinary Catheterization, run by Central Hospital, Nancy, France at 1 site in France.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 8 Aug 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Lefevre, M.D. PhD (+33383154097, b.lefevre@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse OR recurrence of urinary tract infection (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2025.