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

NCT ID: NCT04913753

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-10
• Study Completion Date: 2025-12-03

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?

Conditions

Urinary Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

No systematic CBEU

Patients will not have bacterial culture performed before double J removal.

Group Type: EXPERIMENTAL

No CBEU

Intervention Type: PROCEDURE

Patients in the experimental group will have bacterial culture and double J removal will be performed as usual. .

Systematic CBEU

Patients will have a systematic urine culture performed before double J removal.

Group Type: ACTIVE_COMPARATOR

CBEU

Intervention Type: PROCEDURE

Patients in the control group will have bacterial culture and double J removal will be performed as usual. .

Interventions

CBEU

Patients in the control group will have bacterial culture and double J removal will be performed as usual. .

Intervention Type: PROCEDURE

No CBEU

Patients in the experimental group will have bacterial culture and double J removal will be performed as usual. .

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Tours

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

BRUYERE

Tours, , France

Countries

France

Other Identifiers

DR200086 - ABLAJ

Identifier Type: -

Identifier Source: org_study_id