NCT06503588

Brief 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. 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".

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 16, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

8 months

First QC Date

July 10, 2024

Last Update Submit

August 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Relapse OR recurrence of urinary tract infection

    1 year

Secondary Outcomes (4)

  • Nephro-urologic complication

    1 year

  • Infectious complication

    1 year

  • In-hospital and 1-year mortality

    1 year

  • Resort to Watch or Reserve antibiotics

    1 year

Study Arms (2)

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

Other: Guidelines promoting surgical abstention

Interventions

Guidelines promoting surgical abstention

After guidelines

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nancy university hospital

Nancy, Lorraine, 54000, France

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • +33383154097 Lefevre, M.D. PhD

    Central Hospital, Nancy, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Lefevre, M.D. PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. PhD.

Study Record Dates

First Submitted

July 10, 2024

First Posted

July 16, 2024

Study Start

July 1, 2024

Primary Completion

March 1, 2025

Study Completion

September 1, 2025

Last Updated

August 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations