Ureteral Stent Exchange Abstention in Urinary Tract Infec... | NCT06503588

Studies
Ureteral Stent Exchange Abstention in Urinary Tract Infections

NCT06503588

Sponsor

Central Hospital, Nancy, France

Status

Recruiting

Last Update Posted

Aug 8, 2025Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Urinary Tract Infections
Urinary Catheterization

Interventions

Guidelines promoting surgical abstention

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2024Actual

Primary Completion Date

Mar 1, 2025Actual

Completion Date

Sep 1, 2025Estimated

First Submitted Date

Jul 10, 2024

First Submission Date that Met QC Criteria

Jul 10, 2024

First Posted Date

Jul 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2025

Last Update Posted Date

Aug 8, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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".

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Guidelines promoting surgical abstention	Other	Guidelines promoting surgical abstention	After guidelines

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Nephro-urologic complication	Acute kidney injury ; hematuria ; pain ; stent migration or incrustation	1 year
Infectious complication	Sepsis or septic shock

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Benjamin Lefevre, M.D. PhD	Contact	+33383154097		b.lefevre@chru-nancy.fr
Tahani Sara	Contact	+33383154097		s.tahani@chru-nancy.fr

Overall Officials

Name	Affiliation	Role
+33383154097 Lefevre, M.D. PhD	Central Hospital, Nancy, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nancy university hospital	Recruiting	Nancy	Lorraine	54000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014552	Urinary Tract Infections

Ancestor Terms

ID	Term
D007239	Infections
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided