Ureteral Stent Exchange Abstention in Urinary Tract Infections (JJ-change-UTI)

August 6, 2025 updated by: LEFEVRE Benjamin, Central Hospital, Nancy, France

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".

Study Overview

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Lorraine
      • Nancy, Lorraine, France, 54000
        • Recruiting
        • Nancy University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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

Description

Inclusion Criteria:

  • All patients with indwelling ureteral catheter
  • AND confirmed or probable urinary tract infection

Exclusion Criteria:

  • Patient's opposition
  • History of ileal conduit urinary diversion
  • Second or more urinary tract infection during the study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Guidelines promoting surgical abstention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relapse OR recurrence of urinary tract infection
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nephro-urologic complication
Time Frame: 1 year
Acute kidney injury ; hematuria ; pain ; stent migration or incrustation
1 year
Infectious complication
Time Frame: 1 year
Sepsis or septic shock
1 year
In-hospital and 1-year mortality
Time Frame: 1 year
all cause death
1 year
Resort to Watch or Reserve antibiotics
Time Frame: 1 year
antibiotics' WHO classifcation
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: +33383154097 Lefevre, M.D. PhD, Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Actual)

March 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

July 10, 2024

First Submitted That Met QC Criteria

July 10, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

August 8, 2025

Last Update Submitted That Met QC Criteria

August 6, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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