Clinical trial NCT05534399: Antibiotic Strategy and Asymptomatic Bacteriuria in the Context of Intra-vesical Botulinum Toxin A Injections.
Official title: Assessment of the Interest of a Peri-operative Antibiotic Strategy Applied to Patients With Asymptomatic Bacteriuria Undergoing Intra-vesical Botulinum Toxin A Injections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Tract Disease
Keywords: Neurogenic lower urinary tract dysfunction
Clean Intermittent Self Catheterization
Asymptomatic bacteriuria
Botulinum toxin A
Sparing antibiotic strategy
Safety
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2022-09-09
Enrollment: 526
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Rate of patients with symptomatic UTI occurring within the 6 weeks following the injections.
timeFrame: During the 6 weeks following the injections
Secondary outcomes:
measure: Rate of patients with febrile symptomatic UTI occurring within the 6 weeks following BoNTA injections.occurring within the 6 weeks following the injections.
timeFrame: During the 6 weeks following the injections
measure: Rate of patients with non-febrile symptomatic UTI occurring within the 6 weeks following BoNTA injections
timeFrame: During the 6 weeks following the injections
measure: Rate of patients with symptomatic UTI within the 6 weeks following BoNTA injections finally needing the administration of an antibiotic therapy.
timeFrame: During the 6 weeks following the injections
measure: Rate of patients with complication (other than symptomatic UTI) related to* BoNTA injections occurring within the 6 weeks following the injections.
timeFrame: During the 6 weeks following the injections
measure: Rate of patients with complication not related to** BoNTA injections occurring within the 6 weeks following the injections.
timeFrame: During the 6 weeks following the injections
measure: Rate of patients with admission to an emergency unit related to* BoNTA injections occurring within the 6 weeks following the injections.
timeFrame: During the 6 weeks following the injections
measure: Rate of patients with admission to an emergency unit not related** to BoNTA occurring within the 6 weeks following the injections
timeFrame: During the 6 weeks following the injections
measure: Rate of patients with admission in a non-scheduled hospitalization related to* BoNTA injections occurring within the 6 weeks following the injections.
timeFrame: During the 6 weeks following the injections
measure: Rate of patients with admission in a non-scheduled hospitalization not related to* BoNTA injections occurring within the 6 weeks following the injections.
timeFrame: During the 6 weeks following the injections
measure: Maximal cystometric capacity (MCC)
timeFrame: 6 weeks after BoNTA injections.
measure: Rate of patients with detrusor overactivity (non-voiding detrusor contractions during feeling phase)
timeFrame: 6 weeks after BoNTA injections.
measure: Number of CISC per day
timeFrame: 6 weeks after BoNTA injections.
measure: Number of urgency episodes per day
timeFrame: 6 weeks after BoNTA injections.
measure: Number of urinary incontinence episodes per day
timeFrame: 6 weeks after BoNTA injections.
measure: Functional bladder capacity
timeFrame: 6 weeks after BoNTA injections.
measure: Identify risk factors of in-hospital postoperative symptomatic UTI
timeFrame: 6 weeks after BoNTA injections.
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Xavier BIARDEAU, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.