Urinary InfectionAblaJNCT04913753
Relevance of the Urine Bacterial Culture Performed Before Double J Ablation for Post-operative Urinary Tract Infection Prevention
A study testing CBEU and No CBEU in people with Urinary Infection, run by University Hospital, Tours at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Urinary Infection
- What is being tested?
- CBEU and No CBEU
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,200 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jun 2021to 3 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients already receiving antibiotics other than urological reasons and transplanted patients
- Study interventions contraindications
- Pregnancy, breastfeeding
- Patient under tutorship or curators
- Deprivation of liberty
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- CBEU, No CBEU
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBEUProcedure or surgery
Patients in the control group will have bacterial culture and double J removal will be performed as usual. .
No CBEUProcedure or surgery
Patients in the experimental group will have bacterial culture and double J removal will be performed as usual. .
| Study group | Role | What they receive |
|---|---|---|
| No systematic CBEU | Experimental | Patients will not have bacterial culture performed before double J removal. Receives: Procedure: No CBEU |
| Systematic CBEU | Active comparator | Patients will have a systematic urine culture performed before double J removal. Receives: Procedure: CBEU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month post double J removal
Secondary outcomes (7)
Incidence of bacteriuria measured by CBEU
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
Measured: 1 month post double J removal
Description of the resistance type of pre-operative distribution of bacteriuria by CBEU
Epidemiology of the resistance type of pre-operative bacteriuria
Measured: 10 days to 4 days before double J removal
Description of the pre-operative distribution of bacteriuria by CBEU
Epidemiology of pre-operative bacteriuria
Measured: 10 days to 4 days before double J removal
Description of the resistance type of post operative distribution of bacteriuria by CBEU
Epidemiology of the resistance type of post-ablation bacteriuria
Measured: 1 month after double J removal
Description of the post operative distribution of bacteriuria by CBEU
Epidemiology of post-ablation bacteriuria
Measured: 1 month after double J removal
Composition of microbiome by bacterial urinary analysis
Comparison of the pre-operative urinary microbiome to the post-ablation urinary microbiome in patient with post-ablation infection.
Measured: 1 month post double J removal
Health-economic outcome
Proportion of incremental costs-effects pairs that lies in the non-inferiority area, for various values of economic non-inferiority
Measured: 1 month post double J removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start10 Jun 2021
- Primary completion3 Dec 2025
- Study completion3 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913753
- Sponsor's protocol ID
- DR200086 - ABLAJ
- Acronym
- AblaJ
- Status last verified
- Dec 2025
- First submitted
- 19 May 2021
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relevance of the Urine Bacterial Culture Performed Before Double J Ablation for Post-operative Urinary Tract Infection Prevention
- ClinicalTrials.gov ID
- NCT04913753
- Acronym / sponsor ID
- AblaJ / DR200086 - ABLAJ
- Conditions
- Urinary Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,200 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 3 Dec 2025 (actual)
- Study completion
- 3 Dec 2025 (actual)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No systematic CBEU | Experimental | Procedure: No CBEUPatients will not have bacterial culture performed before double J removal. |
| Systematic CBEU | Active comparator | Procedure: CBEUPatients will have a systematic urine culture performed before double J removal. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Patients already receiving antibiotics other than urological reasons and transplanted patients
- Study interventions contraindications
- Pregnancy, breastfeeding
- Patient under tutorship or curators
- Deprivation of liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBEUPatients in the control group will have bacterial culture and double J removal will be performed as usual. . | Procedure or surgery | Systematic CBEU |
| No CBEUPatients in the experimental group will have bacterial culture and double J removal will be performed as usual. . | Procedure or surgery | No systematic CBEU |
Primary outcome
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.
7 secondary outcomes
Incidence of bacteriuria measured by CBEU
Time frame: 1 month post double J removal
Description of the resistance type of pre-operative distribution of bacteriuria by CBEU
Time frame: 10 days to 4 days before double J removal
Description of the pre-operative distribution of bacteriuria by CBEU
Time frame: 10 days to 4 days before double J removal
Description of the resistance type of post operative distribution of bacteriuria by CBEU
Time frame: 1 month after double J removal
Description of the post operative distribution of bacteriuria by CBEU
Time frame: 1 month after double J removal
Composition of microbiome by bacterial urinary analysis
Time frame: 1 month post double J removal
Health-economic outcome
Time frame: 1 month post double J removal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBEU and No CBEU in people with Urinary Infection, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of infection (time frame: 1 month post double J removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.