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

N/ANot Yet RecruitingNCT05534399

University Hospital, Lille526 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

526

Conditions

Urinary Tract Disease

Interventions

Intra-vesical BoNTA injectionsPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hop Claude Huriez Chu Lille

Lille, France

Outcomes

Primary Outcomes

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