Clinical trial NCT04913753: Relevance of the Urine Bacterial Culture Performed Before Double J Ablation for Post-operative Urinary Tract Infection Prevention
Official title: Relevance of the Urine Bacterial Culture Performed Before Double J Ablation for Post-operative Urinary Tract Infection Prevention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Infection
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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?

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

Primary outcomes:
measure: Incidence of infection
timeFrame: 1 month post double J removal
Secondary outcomes:
measure: Incidence of bacteriuria measured by CBEU
timeFrame: 1 month post double J removal
measure: Description of the resistance type of pre-operative distribution of bacteriuria by CBEU
timeFrame: 10 days to 4 days before double J removal
measure: Description of the pre-operative distribution of bacteriuria by CBEU
timeFrame: 10 days to 4 days before double J removal
measure: Description of the resistance type of post operative distribution of bacteriuria by CBEU
timeFrame: 1 month after double J removal
measure: Description of the post operative distribution of bacteriuria by CBEU
timeFrame: 1 month after double J removal
measure: Composition of microbiome by bacterial urinary analysis
timeFrame: 1 month post double J removal
measure: Health-economic outcome
timeFrame: 1 month post double J removal
Other outcomes:
Locations:
city: Tours
country: France
facility: BRUYERE
Study officials:
References: