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

NCT05534399 | Not Yet Recruiting DMC

• 3 other identifiers: 2020_032020-A03361-38PHRC-19-0218
• Study Type: interventional
• Target: 526
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Neurogenic lower urinary tract dysfunction; Clean Intermittent Self Catheterization; Asymptomatic bacteriuria; Botulinum toxin A; Sparing antibiotic strategy; Safety

Outcome Measures

Primary Outcomes (1)

• Rate of patients with symptomatic UTI occurring within 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

  During the 6 weeks following the injections

Secondary Outcomes (16)

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

  During the 6 weeks following the injections

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

  During the 6 weeks following the injections

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

  During the 6 weeks following the injections

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

  During the 6 weeks following the injections

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

  During the 6 weeks following the injections

Study Arms (2)

Sparing antibiotic strategy

EXPERIMENTAL

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

Procedure: Intra-vesical BoNTA injections

Peri-operative antibiotic strategy

SHAM COMPARATOR

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

Procedure: Intra-vesical BoNTA injections

Interventions

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.

Peri-operative antibiotic strategy; Sparing antibiotic strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Having already participated to the study
• Augmentation cystoplasty
• Bladder compliance disorders (\<20 mL/cmH2O)
• Ongoing cyclic antibiotic therapy
• Ongoing corticosteroid therapy
• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Ministry of Health, France: collaborator

Study Sites (1)

Hop Claude Huriez Chu Lille

Lille, 59037, France

Location

Related Publications (6)

• Leitner L, Sammer U, Walter M, Knupfer SC, Schneider MP, Seifert B, Tornic J, Mehnert U, Kessler TM. Antibiotic prophylaxis may not be necessary in patients with asymptomatic bacteriuria undergoing intradetrusor onabotulinumtoxinA injections for neurogenic detrusor overactivity. Sci Rep. 2016 Sep 12;6:33197. doi: 10.1038/srep33197.

  PMID: 27616488 BACKGROUND

• Weglinski L, Rouzaud C, Even A, Bouchand F, Davido B, Duran C, Salomon J, Perronne C, Denys P, Chartier-Kastler E, Dinh A. Prospective evaluation of antibiotic treatment for urological procedure in patients presenting with neurogenic bladder. Med Mal Infect. 2016 Sep;46(6):300-7. doi: 10.1016/j.medmal.2016.04.001. Epub 2016 May 27.

  PMID: 27241225 BACKGROUND

• Costelloe C, Metcalfe C, Lovering A, Mant D, Hay AD. Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta-analysis. BMJ. 2010 May 18;340:c2096. doi: 10.1136/bmj.c2096.

  PMID: 20483949 BACKGROUND

• Kang MS, Lee BS, Lee HJ, Hwang SW, Han ZA. Prevalence of and Risk Factors for Multidrug-Resistant Bacteria in Urine Cultures of Spinal Cord Injury Patients. Ann Rehabil Med. 2015 Oct;39(5):686-95. doi: 10.5535/arm.2015.39.5.686. Epub 2015 Oct 26.

  PMID: 26605166 BACKGROUND

• Hansson S, Jodal U, Lincoln K, Svanborg-Eden C. Untreated asymptomatic bacteriuria in girls: II--Effect of phenoxymethylpenicillin and erythromycin given for intercurrent infections. BMJ. 1989 Apr 1;298(6677):856-9. doi: 10.1136/bmj.298.6677.856.

  PMID: 2497823 BACKGROUND

• Cai T, Mazzoli S, Mondaini N, Meacci F, Nesi G, D'Elia C, Malossini G, Boddi V, Bartoletti R. The role of asymptomatic bacteriuria in young women with recurrent urinary tract infections: to treat or not to treat? Clin Infect Dis. 2012 Sep;55(6):771-7. doi: 10.1093/cid/cis534. Epub 2012 Jun 7.

  PMID: 22677710 BACKGROUND

MeSH Terms

Conditions

Urologic Diseases

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Xavier BIARDEAU, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xavier BIARDEAU, MD

CONTACT

0320445962; xavier.biardeau@chru-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: September 9, 2022
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

FR (1)