Back to resultsAntibiotic Strategy and Asymptomatic Bacteriuria in the Context of Intra-vesical Botulinum Toxin A Injections. (ANTIBIOBONTA)
Primary Purpose
Urinary Tract Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Intra-vesical BoNTA injections
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Tract Disease focused on measuring Neurogenic lower urinary tract dysfunction, Clean Intermittent Self Catheterization, Asymptomatic bacteriuria, Botulinum toxin A, Sparing antibiotic strategy, Safety
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
- 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
Sites / Locations
- Hop Claude Huriez Chu Lille
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Sparing antibiotic strategy
Peri-operative antibiotic strategy
Arm Description
No antibiotic therapy will be administered during the peri-operative period
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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.
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
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.
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.
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.
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.
Maximal cystometric capacity (MCC)
Maximal cystometric capacity (MCC) measured during the urodynamic multichannel study
Rate of patients with detrusor overactivity (non-voiding detrusor contractions during feeling phase)
Detrusor overactivity measured during the urodynamic multichannel study
Number of CISC per day
Number of CISC measured on a 3-day bladder diary
Number of urgency episodes per day
Number of urgency episodes measured on a 3-day bladder diary
Number of urinary incontinence episodes per day
Number of urinary incontinence episodes measured on a 3-day bladder diary
Functional bladder capacity
Functional bladder capacity measured on a 3-day bladder diary
Identify risk factors of in-hospital postoperative symptomatic UTI
Full Information
NCT ID
NCT05534399
First Posted
June 7, 2022
Last Updated
September 6, 2022
Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
1. Study Identification
Unique Protocol Identification Number
NCT05534399
Brief Title
Antibiotic Strategy and Asymptomatic Bacteriuria in the Context of Intra-vesical Botulinum Toxin A Injections.
Acronym
ANTIBIOBONTA
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Disease
Keywords
Neurogenic lower urinary tract dysfunction, Clean Intermittent Self Catheterization, Asymptomatic bacteriuria, Botulinum toxin A, Sparing antibiotic strategy, Safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
526 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sparing antibiotic strategy
Arm Type
Experimental
Arm Description
No antibiotic therapy will be administered during the peri-operative period
Arm Title
Peri-operative antibiotic strategy
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Intra-vesical BoNTA injections
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of patients with symptomatic UTI occurring within the 6 weeks following the injections.
Description
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
Time Frame
During the 6 weeks following the injections
Secondary Outcome Measure Information:
Title
Rate of patients with febrile symptomatic UTI occurring within the 6 weeks following BoNTA injections.occurring within the 6 weeks following the injections.
Description
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
Time Frame
During the 6 weeks following the injections
Title
Rate of patients with non-febrile symptomatic UTI occurring within the 6 weeks following BoNTA injections
Description
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
Time Frame
During the 6 weeks following the injections
Title
Rate of patients with symptomatic UTI within the 6 weeks following BoNTA injections finally needing the administration of an antibiotic therapy.
Description
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
Time Frame
During the 6 weeks following the injections
Title
Rate of patients with complication (other than symptomatic UTI) related to* BoNTA injections occurring within the 6 weeks following the injections.
Description
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.
Time Frame
During the 6 weeks following the injections
Title
Rate of patients with complication not related to** BoNTA injections occurring within the 6 weeks following the injections.
Description
Any complication not listed in the complications "related to" the injections
Time Frame
During the 6 weeks following the injections
Title
Rate of patients with admission to an emergency unit related to* BoNTA injections occurring within the 6 weeks following the injections.
Description
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.
Time Frame
During the 6 weeks following the injections
Title
Rate of patients with admission to an emergency unit not related** to BoNTA occurring within the 6 weeks following the injections
Description
Any complication not listed in the complications "related to" the injections.
Time Frame
During the 6 weeks following the injections
Title
Rate of patients with admission in a non-scheduled hospitalization related to* BoNTA injections occurring within the 6 weeks following the injections.
Description
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.
Time Frame
During the 6 weeks following the injections
Title
Rate of patients with admission in a non-scheduled hospitalization not related to* BoNTA injections occurring within the 6 weeks following the injections.
Description
Any complication not listed in the complications "related to" the injections.
Time Frame
During the 6 weeks following the injections
Title
Maximal cystometric capacity (MCC)
Description
Maximal cystometric capacity (MCC) measured during the urodynamic multichannel study
Time Frame
6 weeks after BoNTA injections.
Title
Rate of patients with detrusor overactivity (non-voiding detrusor contractions during feeling phase)
Description
Detrusor overactivity measured during the urodynamic multichannel study
Time Frame
6 weeks after BoNTA injections.
Title
Number of CISC per day
Description
Number of CISC measured on a 3-day bladder diary
Time Frame
6 weeks after BoNTA injections.
Title
Number of urgency episodes per day
Description
Number of urgency episodes measured on a 3-day bladder diary
Time Frame
6 weeks after BoNTA injections.
Title
Number of urinary incontinence episodes per day
Description
Number of urinary incontinence episodes measured on a 3-day bladder diary
Time Frame
6 weeks after BoNTA injections.
Title
Functional bladder capacity
Description
Functional bladder capacity measured on a 3-day bladder diary
Time Frame
6 weeks after BoNTA injections.
Title
Identify risk factors of in-hospital postoperative symptomatic UTI
Time Frame
6 weeks after BoNTA injections.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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)
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier BIARDEAU, MD
Phone
0320445962
Ext
+33
Email
xavier.biardeau@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier BIARDEAU, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hop Claude Huriez Chu Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Contact:
Phone
0320445962
12. IPD Sharing Statement
Citations:
PubMed Identifier
27616488
Citation
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.
Results Reference
background
PubMed Identifier
27241225
Citation
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.
Results Reference
background
PubMed Identifier
20483949
Citation
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.
Results Reference
background
PubMed Identifier
26605166
Citation
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.
Results Reference
background
PubMed Identifier
2497823
Citation
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.
Results Reference
background
PubMed Identifier
22677710
Citation
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.
Results Reference
background
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Antibiotic Strategy and Asymptomatic Bacteriuria in the Context of Intra-vesical Botulinum Toxin A Injections.
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