Relevance of the Urine Bacterial Culture Performed Before Double J Ablation for Post-operative Urinary Tract Infection Prevention

Urinary Infection Clinical Trial

— AblaJ  

Official title:

Relevance of the Urine Bacterial Culture Performed Before Double J Ablation for Post-operative Urinary Tract Infection Prevention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04913753
• Other study ID #: DR200086 - ABLAJ
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2021
• Est. completion date: October 30, 2024

Study information

• Verified date: June 2023
• Source: University Hospital, Tours
• Contact: Franck BRUYERE, PhD
• Phone: +33 2 34 38 95 63
• Email: f.bruyere[@]chu-tours.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The value of cytobacteriological examination of urine (CBEU) before double J catheter removal has not been demonstrated. The aim of this study is to define the interest of this CBEU.

Description:

Double J stents are ureteral catheters that allow urine to flow from the kidney without difficulty. These catheters protect the ureterovesical anastomosis of a renal transplant or reduce the postoperative oedema, for example after stone removal by ureteroscopy. These catheters are removed in an outpatient setting under local anaesthesia. Post ablation infections of double J catheters have been poorly studied but their incidence varied according to the populations and the definition used (10 to 54% for colonization, 1 to 10% for symptomatic infection). The national and international guidelines advocate a routine urine bacterial culture (UBC) before double J catheter removal as the procedure is in contact with urine; but there is no evidence of its interest. In case of positivity of this culture, it is recommended to delay the intervention or, what is more often chosen, to treat with antibiotic to cover the procedure. Investigators can thus ask 2 questions: is it rightful to withdraw a double J removal while the UBC is falsely negative and in case of a positive bacterial culture is there an increased risk of post-ablation infection?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2200
• Est. completion date: October 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Participant = 18 years of age

• Scheduled to have a double J catheter ablation

• Participants covered by or entitled to social security

• Written informed consent obtained from the participant

• Ability for participant to comply with the requirements of the study

Exclusion Criteria:

• Patients already receiving antibiotics other than urological reasons and transplanted patients

• Study interventions contraindications

• Pregnancy, breastfeeding

• Patient under tutorship or curators

• Deprivation of liberty

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Urinary Infection
• Urinary Tract Infections

Intervention

Procedure:
• CBEU
Patients in the control group will have bacterial culture and double J removal will be performed as usual. .
• No CBEU
Patients in the experimental group will have bacterial culture and double J removal will be performed as usual. .

Locations

Country	Name	City	State
France	BRUYERE	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of infection	Incidence over a month period of post-ablation symptomatic urinary infection defined by the presence of symptoms validated by an adjudication committee (urine burning, fever, urgencies… associated to a significant bacteriuria) - each patient will be contacted by phone at month 1 (± 5 days) and will be asked to contact us in case of suspicion of urinary infection.	1 month post double J removal
Secondary	Incidence of bacteriuria measured by CBEU	Incidence of post-ablation bacteriuria (urosepsis and antibiotic use) in different groups of patients (reason of the stent, duration of the insertion, previous infection, immunodepression….) in the 1 month post-ablation period	1 month post double J removal
Secondary	Description of the resistance type of pre-operative distribution of bacteriuria by CBEU	Epidemiology of the resistance type of pre-operative bacteriuria	10 days to 4 days before double J removal
Secondary	Description of the pre-operative distribution of bacteriuria by CBEU	Epidemiology of pre-operative bacteriuria	10 days to 4 days before double J removal
Secondary	Description of the resistance type of post operative distribution of bacteriuria by CBEU	Epidemiology of the resistance type of post-ablation bacteriuria	1 month after double J removal
Secondary	Description of the post operative distribution of bacteriuria by CBEU	Epidemiology of post-ablation bacteriuria	1 month after double J removal
Secondary	Composition of microbiome by bacterial urinary analysis	Comparison of the pre-operative urinary microbiome to the post-ablation urinary microbiome in patient with post-ablation infection.	1 month post double J removal
Secondary	Health-economic outcome	Proportion of incremental costs-effects pairs that lies in the non-inferiority area, for various values of economic non-inferiority	1 month post double J removal