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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

Having already participated to the study

Augmentation cystoplasty

Bladder compliance disorders (<20 mL/cmH2O)

Ongoing cyclic antibiotic therapy

Trial design

Treatments tested in this trial

  • Intra-vesical BoNTA injections

Treatment groups

526 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital, Lille

Lead sponsor

Ministry of Health, France

Collaborator