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Completed

NCT Number: NCT04913753

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BRUYERE

Tours, 37044, France

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBEU

Procedure

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

No CBEU

Procedure

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

Primary outcomes

  1. Incidence of infection

    Time frame: 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 outcomes

  1. Incidence of bacteriuria measured by CBEU

    Time frame: 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

  2. Description of the resistance type of pre-operative distribution of bacteriuria by CBEU

    Time frame: 10 days to 4 days before double J removal

    Epidemiology of the resistance type of pre-operative bacteriuria

  3. Description of the pre-operative distribution of bacteriuria by CBEU

    Time frame: 10 days to 4 days before double J removal

    Epidemiology of pre-operative bacteriuria

  4. Description of the resistance type of post operative distribution of bacteriuria by CBEU

    Time frame: 1 month after double J removal

    Epidemiology of the resistance type of post-ablation bacteriuria

  5. Description of the post operative distribution of bacteriuria by CBEU

    Time frame: 1 month after double J removal

    Epidemiology of post-ablation bacteriuria

  6. Composition of microbiome by bacterial urinary analysis

    Time frame: 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.

  7. Health-economic outcome

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: AblaJ

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 4, 2021
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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