Urinary Tract DiseaseANTIBIOBONTANCT05534399
Antibiotic Strategy and Asymptomatic Bacteriuria in the Context of Intra-vesical Botulinum Toxin A Injections.
A study testing Intra-vesical BoNTA injections in people with Urinary Tract Disease, run by University Hospital, Lille at 1 site in France.
Trial summary
The study aims to demonstrate that the "thrifty antibiotic strategy" applied to MS or SCI patients with asymptomatic bacteriuria prior to BoNTA intravesical injections does not increase the rate of symptomatic post-injection UTIs compared to the current peri-operative antibiotic strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Disease
- What is being tested?
- Intra-vesical BoNTA injections
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 526 participants
- Where
- 1 siteFrance
- Study dates
- May 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MS or SCI (traumatic or non-traumatic)
- Refractory OAB and/or DO (failure, intolerance or contra-indication to anti-muscarinic therapy)
- Treated with intra-vesical botulinum toxin A injections having proved efficacy
- CISC as the exclusive bladder management
- AB on pre-operative urine analysis (performed 10 days (+/- 2 days) before intra-vesical BoNTA injections)
- Exclusion of morphologic urinary tract abnormalities considered as a risk factor for recurrent symptomatic UTI.
Who cannot join
- Having already participated to the study
- Augmentation cystoplasty
- Bladder compliance disorders (<20 mL/cmH2O)
- Ongoing cyclic antibiotic therapy
- Ongoing corticosteroid therapy
- Modification of immunosuppressive or immunomodulatory therapy in the 3 months before inclusion (MS patients)
Show all 15Show fewer
- Antibiotic therapy in the month before inclusion
- Surgical procedure in the 3 months before and the 6 weeks following inclusion
- Symptomatic UTI at the time of inclusion
- Associated neurologic disease
- Pregnancy or breast feeding
- Individuals especially in need of protection
- No informed consent
- Patients incapable to follow the trial, e.g. because of language problems, psychiatric disorders, dementia and so on
- Immunocompromised patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of the Interest of a Peri-operative Antibiotic Strategy Applied to Patients With Asymptomatic Bacteriuria Undergoing Intra-vesical Botulinum Toxin A Injections
The study aims to demonstrate that the "thrifty antibiotic strategy" applied to MS or SCI patients with asymptomatic bacteriuria prior to BoNTA intravesical injections does not increase the rate of symptomatic post-injection UTIs compared to the current peri-operative antibiotic strategy.
Patients included in the study will be randomized in two balanced-parallel groups, 4 days (+/- 2 days) before intra-vesical BoNTA injections.
Read more
Group 1: Experimental group: "Sparing antibiotic strategy" No antibiotic therapy will be administered during the peri-operative period.
Group 2: Control group: Recommendations - Peri-operative antibiotic strategy An antibiotic therapy will be administered during the peri-operative period. The antibiotic will be selected according to the type of bacteria isolated and the antibiotic susceptibility testing, and started two days before and pursued until two days following intra-vesical BoNTA injections.
The main objective is to demonstrate the non-inferiority of "antibiotic saving strategy" compared to peri-operative antibiotic strategy (current recommendations) for occurrence of symptomatic UTI after intra-vesical BoNTA injections in the management of asymptomatic bacteriuria (AB) among multiple sclerosis (MS) and spinal cord injured (SCI) patients undergoing clean intermittent self-catheterization (CISC).
- Conditions
- Urinary Tract Disease
- Being tested
- Intra-vesical BoNTA injections
- Keywords
- Neurogenic lower urinary tract dysfunction, Clean Intermittent Self Catheterization, Asymptomatic bacteriuria, Botulinum toxin A, Sparing antibiotic strategy, Safety
- Medical subject headings
- Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-vesical BoNTA injectionsProcedure or surgery
Intra-vesical BoNTA injections will be performed according to the protocol currently applied by the department.
They will be performed in the operating room or in the outpatient clinic under strict asepsis, including the wearing of sterile gloves by the surgeon associated with an antiseptic brushing of the patient and the establishment of sterile fields.
A rigid or a flexible cystoscope will be used.
After the introduction of the cystoscope under visual control, complete bladder emptying will be performed. The bladder will be filled again, slowly and at low pressure to allow the bladder mucosa to expand.
BoNTA (BOTOX® 200 U) will be diluted as follows: BOTOX® 200 U: in 30 mL of saline solution
The solution obtained will be injected all along the bladder wall, sparing the trigone in 20 (BOTOX® 200 U) points using a Bonee®-type needle.
A complete bladder emptying will be performed at the end of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Sparing antibiotic strategy | Experimental | No antibiotic therapy will be administered during the peri-operative period Receives: Procedure: Intra-vesical BoNTA injections |
| Peri-operative antibiotic strategy | Sham comparator | Recommendations - An antibiotic therapy will be administered during the peri-operative period.
The antibiotic will be selected according to the type of bacteria isolated and the antibiotic susceptibility testing, and started two days before and pursued until two days following intra-vesical BoNTA injections Receives: Procedure: Intra-vesical BoNTA injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with symptomatic UTI occurring within the 6 weeks following the injections.
Symptomatic UTI will be defined according to the National Institute on Disability and Rehabilitation Research (NIDRR, 1992) as a significant bacteriuria with tissue invasion and resultant tissue response with signs and/or symptoms of UTI
Measured: During the 6 weeks following the injections
Secondary outcomes (16)
Rate of patients with febrile symptomatic UTI occurring within the 6 weeks following BoNTA injections.occurring within the 6 weeks following the injections.
Symptomatic UTI will be defined according to the National Institute on Disability and Rehabilitation Research (NIDRR, 1992) as a significant bacteriuria with tissue invasion and resultant tissue response with signs and/or symptoms of UTI
Measured: During the 6 weeks following the injections
Rate of patients with non-febrile symptomatic UTI occurring within the 6 weeks following BoNTA injections
Symptomatic UTI will be defined according to the National Institute on Disability and Rehabilitation Research (NIDRR, 1992) as a significant bacteriuria with tissue invasion and resultant tissue response with signs and/or symptoms of UTI
Measured: During the 6 weeks following the injections
Rate of patients with symptomatic UTI within the 6 weeks following BoNTA injections finally needing the administration of an antibiotic therapy.
Symptomatic UTI will be defined according to the National Institute on Disability and Rehabilitation Research (NIDRR, 1992) as a significant bacteriuria with tissue invasion and resultant tissue response with signs and/or symptoms of UTI
Measured: During the 6 weeks following the injections
Rate of patients with complication (other than symptomatic UTI) related to* BoNTA injections occurring within the 6 weeks following the injections.
Any complication leading to an admission in an emergency unit : macroscopic hematuria persisting for more than 48 hours after injections, painful catheterization lasting more than 48 hours after intra-vesical BoNTA injections, pseudo-botulism, botulism.
Measured: During the 6 weeks following the injections
Rate of patients with complication not related to** BoNTA injections occurring within the 6 weeks following the injections.
Any complication not listed in the complications "related to" the injections
Measured: During the 6 weeks following the injections
Rate of patients with admission to an emergency unit related to* BoNTA injections occurring within the 6 weeks following the injections.
Any complication leading to an admission in an emergency unit : macroscopic hematuria persisting for more than 48 hours after injections, painful catheterization lasting more than 48 hours after intra-vesical BoNTA injections, pseudo-botulism, botulism.
Measured: During the 6 weeks following the injections
Rate of patients with admission to an emergency unit not related** to BoNTA occurring within the 6 weeks following the injections
Any complication not listed in the complications "related to" the injections.
Measured: During the 6 weeks following the injections
Rate of patients with admission in a non-scheduled hospitalization related to* BoNTA injections occurring within the 6 weeks following the injections.
Any complication leading to an admission in an emergency unit : macroscopic hematuria persisting for more than 48 hours after injections, painful catheterization lasting more than 48 hours after intra-vesical BoNTA injections, pseudo-botulism, botulism.
Measured: During the 6 weeks following the injections
Rate of patients with admission in a non-scheduled hospitalization not related to* BoNTA injections occurring within the 6 weeks following the injections.
Any complication not listed in the complications "related to" the injections.
Measured: During the 6 weeks following the injections
Maximal cystometric capacity (MCC)
Maximal cystometric capacity (MCC) measured during the urodynamic multichannel study
Measured: 6 weeks after BoNTA injections.
Rate of patients with detrusor overactivity (non-voiding detrusor contractions during feeling phase)
Detrusor overactivity measured during the urodynamic multichannel study
Measured: 6 weeks after BoNTA injections.
Number of CISC per day
Number of CISC measured on a 3-day bladder diary
Measured: 6 weeks after BoNTA injections.
Number of urgency episodes per day
Number of urgency episodes measured on a 3-day bladder diary
Measured: 6 weeks after BoNTA injections.
Number of urinary incontinence episodes per day
Number of urinary incontinence episodes measured on a 3-day bladder diary
Measured: 6 weeks after BoNTA injections.
Functional bladder capacity
Functional bladder capacity measured on a 3-day bladder diary
Measured: 6 weeks after BoNTA injections.
Identify risk factors of in-hospital postoperative symptomatic UTI
Measured: 6 weeks after BoNTA injections.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study startMay 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 526 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Xavier BIARDEAU, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534399
- Sponsor's protocol ID
- 2020_03
- Other IDs
- 2020-A03361-38, PHRC-19-0218
- Acronym
- ANTIBIOBONTA
- Status last verified
- Dec 2025
- First submitted
- 7 Jun 2022
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Leitner L, Sammer U, Walter M, Knupfer SC, Schneider MP, Seifert B, Tornic J, Mehnert U, Kessler TM. Antibiotic prophylaxis may not be necessary in patients with asymptomatic bacteriuria undergoing intradetrusor onabotulinumtoxinA injections for neurogenic detrusor overactivity. Sci Rep. 2016 Sep 12;6:33197. doi: 10.1038/srep33197.
PubMed 27616488Weglinski L, Rouzaud C, Even A, Bouchand F, Davido B, Duran C, Salomon J, Perronne C, Denys P, Chartier-Kastler E, Dinh A. Prospective evaluation of antibiotic treatment for urological procedure in patients presenting with neurogenic bladder. Med Mal Infect. 2016 Sep;46(6):300-7. doi: 10.1016/j.medmal.2016.04.001. Epub 2016 May 27.
PubMed 27241225Costelloe C, Metcalfe C, Lovering A, Mant D, Hay AD. Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta-analysis. BMJ. 2010 May 18;340:c2096. doi: 10.1136/bmj.c2096.
PubMed 20483949Kang MS, Lee BS, Lee HJ, Hwang SW, Han ZA. Prevalence of and Risk Factors for Multidrug-Resistant Bacteria in Urine Cultures of Spinal Cord Injury Patients. Ann Rehabil Med. 2015 Oct;39(5):686-95. doi: 10.5535/arm.2015.39.5.686. Epub 2015 Oct 26.
PubMed 26605166Hansson S, Jodal U, Lincoln K, Svanborg-Eden C. Untreated asymptomatic bacteriuria in girls: II--Effect of phenoxymethylpenicillin and erythromycin given for intercurrent infections. BMJ. 1989 Apr 1;298(6677):856-9. doi: 10.1136/bmj.298.6677.856.
PubMed 2497823Cai T, Mazzoli S, Mondaini N, Meacci F, Nesi G, D'Elia C, Malossini G, Boddi V, Bartoletti R. The role of asymptomatic bacteriuria in young women with recurrent urinary tract infections: to treat or not to treat? Clin Infect Dis. 2012 Sep;55(6):771-7. doi: 10.1093/cid/cis534. Epub 2012 Jun 7.
PubMed 22677710
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Interest of a Peri-operative Antibiotic Strategy Applied to Patients With Asymptomatic Bacteriuria Undergoing Intra-vesical Botulinum Toxin A Injections
- ClinicalTrials.gov ID
- NCT05534399
- Acronym / sponsor ID
- ANTIBIOBONTA / 2020_03
- Conditions
- Urinary Tract Disease
- Keywords
- Neurogenic lower urinary tract dysfunction, Clean Intermittent Self Catheterization, Asymptomatic bacteriuria, Botulinum toxin A, Sparing antibiotic strategy, Safety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 526 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- May 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 9 Sep 2022 (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 study aims to demonstrate that the "thrifty antibiotic strategy" applied to MS or SCI patients with asymptomatic bacteriuria prior to BoNTA intravesical injections does not increase the rate of symptomatic post-injection UTIs compared to the current peri-operative antibiotic strategy.
Patients included in the study will be randomized in two balanced-parallel groups, 4 days (+/- 2 days) before intra-vesical BoNTA injections.
Group 1: Experimental group: "Sparing antibiotic strategy" No antibiotic therapy will be administered during the peri-operative period.
Group 2: Control group: Recommendations - Peri-operative antibiotic strategy An antibiotic therapy will be administered during the peri-operative period. The antibiotic will be selected according to the type of bacteria isolated and the antibiotic susceptibility testing, and started two days before and pursued until two days following intra-vesical BoNTA injections.
The main objective is to demonstrate the non-inferiority of "antibiotic saving strategy" compared to peri-operative antibiotic strategy (current recommendations) for occurrence of symptomatic UTI after intra-vesical BoNTA injections in the management of asymptomatic bacteriuria (AB) among multiple sclerosis (MS) and spinal cord injured (SCI) patients undergoing clean intermittent self-catheterization (CISC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sparing antibiotic strategy | Experimental | Procedure: Intra-vesical BoNTA injectionsNo antibiotic therapy will be administered during the peri-operative period |
| Peri-operative antibiotic strategy | Sham comparator | Procedure: Intra-vesical BoNTA injectionsRecommendations - An antibiotic therapy will be administered during the peri-operative period. The antibiotic will be selected according to the type of bacteria isolated and the antibiotic susceptibility testing, and started two days before and pursued until two days following intra-vesical BoNTA injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- MS or SCI (traumatic or non-traumatic)
- Refractory OAB and/or DO (failure, intolerance or contra-indication to anti-muscarinic therapy)
- Treated with intra-vesical botulinum toxin A injections having proved efficacy
- CISC as the exclusive bladder management
- AB on pre-operative urine analysis (performed 10 days (+/- 2 days) before intra-vesical BoNTA injections)
Key exclusion criteria (15 listed)
- Having already participated to the study
- Augmentation cystoplasty
- Bladder compliance disorders (<20 mL/cmH2O)
- Ongoing cyclic antibiotic therapy
- Ongoing corticosteroid therapy
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 |
|---|---|---|
| Intra-vesical BoNTA injectionsIntra-vesical BoNTA injections will be performed according to the protocol currently applied by the department. They will be performed in the operating room or in the outpatient clinic under strict asepsis, including the wearing of sterile gloves by the surgeon associated with an antiseptic brushing of the patient and the establishment of sterile fields. A rigid or a flexible cystoscope will be used. After the introduction of the cystoscope under visual control, complete bladder emptying will be performed. The bladder will be filled again, slowly and at low pressure to allow the bladder mucosa to expand. BoNTA (BOTOX® 200 U) will be diluted as follows: BOTOX® 200 U: in 30 mL of saline solution The solution obtained will be injected all along the bladder wall, sparing the trigone in 20 (BOTOX® 200 U) points using a Bonee®-type needle. A complete bladder emptying will be performed at the end of the procedure. | Procedure or surgery | Peri-operative antibiotic strategy, Sparing antibiotic strategy |
Primary outcome
Rate of patients with symptomatic UTI occurring within the 6 weeks following the injections.
Time frame: During the 6 weeks following the injections
Symptomatic UTI will be defined according to the National Institute on Disability and Rehabilitation Research (NIDRR, 1992) as a significant bacteriuria with tissue invasion and resultant tissue response with signs and/or symptoms of UTI
16 secondary outcomes
Rate of patients with febrile symptomatic UTI occurring within the 6 weeks following BoNTA injections.occurring within the 6 weeks following the injections.
Time frame: During the 6 weeks following the injections
Rate of patients with non-febrile symptomatic UTI occurring within the 6 weeks following BoNTA injections
Time frame: During the 6 weeks following the injections
Rate of patients with symptomatic UTI within the 6 weeks following BoNTA injections finally needing the administration of an antibiotic therapy.
Time frame: During the 6 weeks following the injections
Rate of patients with complication (other than symptomatic UTI) related to* BoNTA injections occurring within the 6 weeks following the injections.
Time frame: During the 6 weeks following the injections
Rate of patients with complication not related to** BoNTA injections occurring within the 6 weeks following the injections.
Time frame: During the 6 weeks following the injections
Rate of patients with admission to an emergency unit related to* BoNTA injections occurring within the 6 weeks following the injections.
Time frame: During the 6 weeks following the injections
Rate of patients with admission to an emergency unit not related** to BoNTA occurring within the 6 weeks following the injections
Time frame: During the 6 weeks following the injections
Rate of patients with admission in a non-scheduled hospitalization related to* BoNTA injections occurring within the 6 weeks following the injections.
Time frame: During the 6 weeks following the injections
Rate of patients with admission in a non-scheduled hospitalization not related to* BoNTA injections occurring within the 6 weeks following the injections.
Time frame: During the 6 weeks following the injections
Maximal cystometric capacity (MCC)
Time frame: 6 weeks after BoNTA injections.
Rate of patients with detrusor overactivity (non-voiding detrusor contractions during feeling phase)
Time frame: 6 weeks after BoNTA injections.
Number of CISC per day
Time frame: 6 weeks after BoNTA injections.
Number of urgency episodes per day
Time frame: 6 weeks after BoNTA injections.
Number of urinary incontinence episodes per day
Time frame: 6 weeks after BoNTA injections.
Functional bladder capacity
Time frame: 6 weeks after BoNTA injections.
Identify risk factors of in-hospital postoperative symptomatic UTI
Time frame: 6 weeks after BoNTA injections.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Background: PubMed 27616488Leitner L, Sammer U, Walter M, Knupfer SC, Schneider MP, Seifert B, Tornic J, Mehnert U, Kessler TM. Antibiotic prophylaxis may not be necessary in patients with asymptomatic bacteriuria undergoing intradetrusor onabotulinumtoxinA injections for neurogenic detrusor overactivity. Sci Rep. 2016 Sep 12;6:33197. doi: 10.1038/srep33197.
- Background: PubMed 27241225Weglinski L, Rouzaud C, Even A, Bouchand F, Davido B, Duran C, Salomon J, Perronne C, Denys P, Chartier-Kastler E, Dinh A. Prospective evaluation of antibiotic treatment for urological procedure in patients presenting with neurogenic bladder. Med Mal Infect. 2016 Sep;46(6):300-7. doi: 10.1016/j.medmal.2016.04.001. Epub 2016 May 27.
- Background: PubMed 20483949Costelloe C, Metcalfe C, Lovering A, Mant D, Hay AD. Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta-analysis. BMJ. 2010 May 18;340:c2096. doi: 10.1136/bmj.c2096.
- Background: PubMed 26605166Kang MS, Lee BS, Lee HJ, Hwang SW, Han ZA. Prevalence of and Risk Factors for Multidrug-Resistant Bacteria in Urine Cultures of Spinal Cord Injury Patients. Ann Rehabil Med. 2015 Oct;39(5):686-95. doi: 10.5535/arm.2015.39.5.686. Epub 2015 Oct 26.
- Background: PubMed 2497823Hansson S, Jodal U, Lincoln K, Svanborg-Eden C. Untreated asymptomatic bacteriuria in girls: II--Effect of phenoxymethylpenicillin and erythromycin given for intercurrent infections. BMJ. 1989 Apr 1;298(6677):856-9. doi: 10.1136/bmj.298.6677.856.
- Background: PubMed 22677710Cai T, Mazzoli S, Mondaini N, Meacci F, Nesi G, D'Elia C, Malossini G, Boddi V, Bartoletti R. The role of asymptomatic bacteriuria in young women with recurrent urinary tract infections: to treat or not to treat? Clin Infect Dis. 2012 Sep;55(6):771-7. doi: 10.1093/cid/cis534. Epub 2012 Jun 7.
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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.
Xavier BIARDEAU, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-vesical BoNTA injections in people with Urinary Tract Disease, run by University Hospital, Lille 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 6 inclusion and 15 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: opening soon, as of the sponsor's last update on 26 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xavier BIARDEAU, MD (0320445962 ext. +33, xavier.biardeau@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with symptomatic UTI occurring within the 6 weeks following the injections. (time frame: During the 6 weeks following the injections). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05534399, which also lists 6 linked publications.
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 26 Dec 2025.