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NCT Number: NCT05534399

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

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).

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Key information

Conditions

Urinary Tract Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hop Claude Huriez Chu Lille

Lille, 59037, France

Location contact

CONTACT

0320445962

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intra-vesical BoNTA injections

Procedure

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 outcomes

  1. Rate of patients with symptomatic UTI occurring within the 6 weeks following the injections.

    Time frame: During 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 outcomes

  1. Rate of patients with febrile symptomatic UTI occurring within the 6 weeks following BoNTA injections.occurring within the 6 weeks following the injections.

    Time frame: During 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

  2. Rate of patients with non-febrile symptomatic UTI occurring within the 6 weeks following BoNTA injections

    Time frame: During 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

  3. Rate of patients with symptomatic UTI within the 6 weeks following BoNTA injections finally needing the administration of an antibiotic therapy.

    Time frame: During 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

  4. Rate of patients with complication (other than symptomatic UTI) related to* BoNTA injections occurring within the 6 weeks following the injections.

    Time frame: During 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.

  5. Rate of patients with complication not related to** BoNTA injections occurring within the 6 weeks following the injections.

    Time frame: During the 6 weeks following the injections

    Any complication not listed in the complications "related to" the injections

  6. Rate of patients with admission to an emergency unit related to* BoNTA injections occurring within the 6 weeks following the injections.

    Time frame: During 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.

  7. Rate of patients with admission to an emergency unit not related** to BoNTA occurring within the 6 weeks following the injections

    Time frame: During the 6 weeks following the injections

    Any complication not listed in the complications "related to" the injections.

  8. Rate of patients with admission in a non-scheduled hospitalization related to* BoNTA injections occurring within the 6 weeks following the injections.

    Time frame: During 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.

  9. Rate of patients with admission in a non-scheduled hospitalization not related to* BoNTA injections occurring within the 6 weeks following the injections.

    Time frame: During the 6 weeks following the injections

    Any complication not listed in the complications "related to" the injections.

  10. Maximal cystometric capacity (MCC)

    Time frame: 6 weeks after BoNTA injections.

    Maximal cystometric capacity (MCC) measured during the urodynamic multichannel study

  11. Rate of patients with detrusor overactivity (non-voiding detrusor contractions during feeling phase)

    Time frame: 6 weeks after BoNTA injections.

    Detrusor overactivity measured during the urodynamic multichannel study

  12. Number of CISC per day

    Time frame: 6 weeks after BoNTA injections.

    Number of CISC measured on a 3-day bladder diary

  13. Number of urgency episodes per day

    Time frame: 6 weeks after BoNTA injections.

    Number of urgency episodes measured on a 3-day bladder diary

  14. Number of urinary incontinence episodes per day

    Time frame: 6 weeks after BoNTA injections.

    Number of urinary incontinence episodes measured on a 3-day bladder diary

  15. Functional bladder capacity

    Time frame: 6 weeks after BoNTA injections.

    Functional bladder capacity measured on a 3-day bladder diary

  16. Identify risk factors of in-hospital postoperative symptomatic UTI

    Time frame: 6 weeks after BoNTA injections.

Study contacts

Contact information is provided by the study sponsor or research team.

Xavier BIARDEAU, MD

CONTACT

[email protected]

0320445962 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

Assessment of the Interest of a Peri-operative Antibiotic Strategy Applied to Patients With Asymptomatic Bacteriuria Undergoing Intra-vesical Botulinum Toxin A Injections

Acronym: ANTIBIOBONTA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2022
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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