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

NCT05534399 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 526

Last updated 2025-12-26

No results posted yet for this study

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).

Conditions

  • Urinary Tract Disease

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Xavier BIARDEAU, MD · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-03-31
Completion
2027-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05534399 on ClinicalTrials.gov