Urinary Infection
Conditions
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?
Interventions
PROCEDURECBEU
Patients in the control group will have bacterial culture and double J removal will be performed as usual. .
PROCEDURENo CBEU
Patients in the experimental group will have bacterial culture and double J removal will be performed as usual. .
Sponsors
University Hospital, Tours
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of infection | 1 month post double J removal | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Description of the resistance type of pre-operative distribution of bacteriuria by CBEU | 10 days to 4 days before double J removal | Epidemiology of the resistance type of pre-operative bacteriuria |
| Description of the pre-operative distribution of bacteriuria by CBEU | 10 days to 4 days before double J removal | Epidemiology of pre-operative bacteriuria |
| Description of the resistance type of post operative distribution of bacteriuria by CBEU | 1 month after double J removal | Epidemiology of the resistance type of post-ablation bacteriuria |
| Incidence of bacteriuria measured by CBEU | 1 month post double J removal | 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 |
| Composition of microbiome by bacterial urinary analysis | 1 month post double J removal | Comparison of the pre-operative urinary microbiome to the post-ablation urinary microbiome in patient with post-ablation infection. |
| Health-economic outcome | 1 month post double J removal | Proportion of incremental costs-effects pairs that lies in the non-inferiority area, for various values of economic non-inferiority |
| Description of the post operative distribution of bacteriuria by CBEU | 1 month after double J removal | Epidemiology of post-ablation bacteriuria |
Countries
France
Outcome results
None listed