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

Study Overview
=================
Brief 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.

Detailed 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?

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

Conditions
-----------------
Urinary Infection

Intervention / Treatment
-----------------
* Procedure: CBEU
* Procedure: No CBEU


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No systematic CBEU<br>Patients will not have bacterial culture performed before double J removal. | Procedure: No CBEU<br>* Patients in the experimental group will have bacterial culture and double J removal will be performed as usual. .<br>|
| Active Comparator: Systematic CBEU<br>Patients will have a systematic urine culture performed before double J removal. | Procedure: CBEU<br>* Patients in the control group will have bacterial culture and double J removal will be performed as usual. .<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Description of the pre-operative distribution of bacteriuria by CBEU | Epidemiology of pre-operative bacteriuria | 10 days to 4 days before double J removal | 
| 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 | 
| Description of the post operative distribution of bacteriuria by CBEU | Epidemiology of post-ablation bacteriuria | 1 month after double J removal | 
| 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 | 
| 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 |