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

Urinary Tract Disease Clinical Trial

— ANTIBIOBONTA  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05534399
• Other study ID #: 2020_03
• Secondary ID: 2020-A03361-38PH
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: August 2023

Study information

• Verified date: June 2022
• Source: University Hospital, Lille
• Contact: Xavier BIARDEAU, MD
• Phone: 0320445962
• Email: xavier.biardeau[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 526
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacteriuria
• Urinary Tract Disease
• Urologic Diseases

Intervention

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.

Locations

Country	Name	City	State
France	Hop Claude Huriez Chu Lille	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (6)

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. — View 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. Review. — View Citation

Hansson S, Jodal U, Lincoln K, Svanborg-Edén C. Untreated asymptomatic bacteriuria in girls: II--Effect of phenoxymethylpenicillin and erythromycin given for intercurrent infections. BMJ. 1989 Apr 1;298(6677):856-9. — View 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. — View Citation

Leitner L, Sammer U, Walter M, Knüpfer 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of patients with febrile symptomatic UTI occurring within the 6 weeks following BoNTA injections.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	Rate of patients with non-febrile symptomatic UTI occurring within the 6 weeks following BoNTA 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	Rate of patients with symptomatic UTI within the 6 weeks following BoNTA injections finally needing the administration of an antibiotic therapy.	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	Rate of patients with complication (other than symptomatic UTI) related to* BoNTA injections occurring within 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.	During the 6 weeks following the injections
Secondary	Rate of patients with complication not related to** BoNTA injections occurring within the 6 weeks following the injections.	Any complication not listed in the complications "related to" the injections	During the 6 weeks following the injections
Secondary	Rate of patients with admission to an emergency unit related to* BoNTA injections occurring within 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.	During the 6 weeks following the injections
Secondary	Rate of patients with admission to an emergency unit not related** to BoNTA occurring within the 6 weeks following the injections	Any complication not listed in the complications "related to" the injections.	During the 6 weeks following the injections
Secondary	Rate of patients with admission in a non-scheduled hospitalization related to* BoNTA injections occurring within 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.	During the 6 weeks following the injections
Secondary	Rate of patients with admission in a non-scheduled hospitalization not related to* BoNTA injections occurring within the 6 weeks following the injections.	Any complication not listed in the complications "related to" the injections.	During the 6 weeks following the injections
Secondary	Maximal cystometric capacity (MCC)	Maximal cystometric capacity (MCC) measured during the urodynamic multichannel study	6 weeks after BoNTA injections.
Secondary	Rate of patients with detrusor overactivity (non-voiding detrusor contractions during feeling phase)	Detrusor overactivity measured during the urodynamic multichannel study	6 weeks after BoNTA injections.
Secondary	Number of CISC per day	Number of CISC measured on a 3-day bladder diary	6 weeks after BoNTA injections.
Secondary	Number of urgency episodes per day	Number of urgency episodes measured on a 3-day bladder diary	6 weeks after BoNTA injections.
Secondary	Number of urinary incontinence episodes per day	Number of urinary incontinence episodes measured on a 3-day bladder diary	6 weeks after BoNTA injections.
Secondary	Functional bladder capacity	Functional bladder capacity measured on a 3-day bladder diary	6 weeks after BoNTA injections.
Secondary	Identify risk factors of in-hospital postoperative symptomatic UTI		6 weeks after BoNTA injections.