Antibiotic Strategy and Asymptomatic Bacteriuria in the Context of Intra-vesical Botulinum Toxin A Injections. (ANTIBIOBONTA)

University Hospital, Lille

Status: Not yet enrolling

Conditions: Urinary Tract Disease

Treatments: Procedure: Intra-vesical BoNTA injections

Study type: Interventional

Funder types: Other

Identifiers

NCT05534399

2020-A03361-38 (Other Identifier)

PHRC-19-0218 (Other Identifier)

2020_03

Details and patient eligibility

About

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).

Enrollment: 526 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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526 participants in 2 patient groups

Sparing antibiotic strategy

Experimental group

Description:

No antibiotic therapy will be administered during the peri-operative period

Treatment:

Procedure: Intra-vesical BoNTA injections

Peri-operative antibiotic strategy

Sham Comparator group

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

Treatment:

Procedure: Intra-vesical BoNTA injections