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

NCT04913753 | Completed

• 1 other identifier: DR200086 - ABLAJ
• Study Type: interventional
• Target: 2,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Incidence of bacteriuria measured by CBEU

  1 month post double J removal

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

  10 days to 4 days before double J removal

• Description of the pre-operative distribution of bacteriuria by CBEU

  10 days to 4 days before double J removal

• Description of the resistance type of post operative distribution of bacteriuria by CBEU

  1 month after double J removal

• Description of the post operative distribution of bacteriuria by CBEU

  1 month after double J removal

Study Arms (2)

No systematic CBEU

EXPERIMENTAL

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

Procedure: No CBEU

Systematic CBEU

ACTIVE COMPARATOR

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

Procedure: CBEU

Interventions

CBEU PROCEDURE

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

Systematic CBEU

No CBEU PROCEDURE

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

No systematic CBEU

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients already receiving antibiotics other than urological reasons and transplanted patients
• Study interventions contraindications
• Pregnancy, breastfeeding
• Patient under tutorship or curators
• Deprivation of liberty

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

BRUYERE

Tours, 37044, France

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: June 4, 2021
• Study Start: June 10, 2021
• Primary Completion: December 3, 2025
• Study Completion: December 3, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

FR (1)