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

U

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)

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

Trial contacts and locations

1

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Central trial contact

Xavier BIARDEAU, MD

Data sourced from clinicaltrials.gov

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