Background/Introduction

Our proposed study aims to identify current practice in the use of antibiotic prophylaxis at the time of cystoscopy in the pediatric population across different Institutions/Countries as well as the rate of postoperative febrile urinary tract infection (fUTI). This could lead to further research questions and develop future research projects aimed at minimizing the use of antibiotics without jeopardizing patients’ safety.

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Research Question

What antibiotic prophylaxis protocols are currently in use among different Institutions/Countries?

What is rate of post-cystoscopy febrile UTI (fUTI)?

Is there any difference based upon geography/institution/center protocol? 

Primary and Secondary Aims

Primary Aim:  To identify the current practice across different Countries

Secondary Aim:               

-To estimate rate of post-cystoscopy fUTI

-To identify possible risk factors for post-cystoscopy fUTI

Study Design

Multi-center, international, non-interventional observational study

Target Population

Pediatric population - all patients <16 years of age undergoing a diagnostic or therapeutic cystoscopy

Inclusion/Exclusion Criteria

Inclusion criteria:

• All patients <16 years of age undergoing a diagnostic or therapeutic cystoscopy at the participating centers

Exclusion criteria:

• incomplete outcome data
• withdrawal from study

Data collection

• Participating centers will be identified before the study period
• Participating centers will provide data concerning all cystoscopies performed in children <16 years of age during the study period including indications, type of cystoscopy performed, type of prophylaxis if any and presence of a postoperative fUTI.
• No identifiable patient data will be collected.
• Data will be collected and stored online through a secure server running the Research Electronic Data (clinsight)
• Hospital Leads will be provided with Clinsight server login details, allowing them to securely submit data
• The Clinsight server is managed by the Centre Hospitalier Universitaire de La Réunion

Study Procedures

All patients will receive their routine care as planned without any modification to each centers standard care. All data will be entered into an anonymized, secured database.

A local investigator will be identified and invited to ensure maximum data collection from his/her center.

Data Analysis

The analysis will describe the primary and secondary outcomes in the cohort.

Local approvals for the patient-level component

The study will be conducted in accordance with national and international guidelines and legislation, as well as the basic principles of the protection of the rights and dignity of Human Beings, as set out in the Helsinki Declaration.

This is an investigator-led, non-commercial, observational (no changes to normal patient care) study which is extremely low risk; only routinely available non-identifiable data will be collected.

Hospital Leads are responsible for obtaining necessary local approvals at each participating site in line with hospital and country regulations. Collaborators will be required to confirm that local approval is in place at the time of uploading each patient record to the study database

Administrative Organization/Roles and Responsibilities

Promotor : CHU de La Réunion

Use of Study Results

The results of the study will be used for presentations and publications.

Up to 2 investigators per participating center will get recognition on subsequent publications.