Antibiotic Strategy and Asymptomatic Bacteriuria in the Context of Intra-vesical Botulinum Toxin A Injections.
NCT ID: NCT05534399
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
526 participants
INTERVENTIONAL
2026-05-31
2027-05-31
Brief Summary
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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).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sparing antibiotic strategy
No antibiotic therapy will be administered during the peri-operative period
Intra-vesical BoNTA injections
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.
Peri-operative antibiotic strategy
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
Intra-vesical BoNTA injections
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.
Interventions
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Intra-vesical BoNTA injections
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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)
* 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
18 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Xavier BIARDEAU, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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Hop Claude Huriez Chu Lille
Lille, , France
Countries
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Central Contacts
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Facility Contacts
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Role: primary
References
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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.
Weglinski 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.
Costelloe 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.
Kang 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.
Hansson 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.
Cai 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.
Other Identifiers
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2020_03
Identifier Type: -
Identifier Source: org_study_id
2020-A03361-38
Identifier Type: OTHER
Identifier Source: secondary_id
PHRC-19-0218
Identifier Type: OTHER
Identifier Source: secondary_id