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

Urinary Tract Disease Clinical Trial

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

Status Not yet recruiting

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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05534399
Study type	Interventional
Source	University Hospital, Lille
Contact	Xavier BIARDEAU, MD
Phone	0320445962
Email	xavier.biardeau@chru-lille.fr
Status	Not yet recruiting
Phase	N/A
Start date	September 2022
Completion date	August 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04288427` - 5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy	N/A
Completed	`NCT00610064` - Brain Effects of Sacral Neuromodulation	N/A
Completed	`NCT06260917` - The Effect of Urinating Through the Zipper or by Pulling Down the Trousers on Uroflowmetry Parameters in LUTS
Completed	`NCT00610233` - Effect of Deep Brain Stimulation on Lower Urinary Tract Function	N/A
Not yet recruiting	`NCT05134675` - Does Homebrewing Beer Affect Urinary Tract Symptoms and Bladder Cancer
Completed	`NCT05260554` - Effect of Cranberry Extract on the Urinary System
Completed	`NCT05574257` - Comparison of the Effect of Remimazolam and Propofol on Perioperative Hypothermia Under Spinal Anesthesia	N/A
Completed	`NCT03676972` - To Evaluate the Safety and Efficacy of LithoVue Ureteroscope System in Chinese Patients With Urinary Disease	N/A
Recruiting	`NCT05153694` - Infectious Complications After Cystectomy: A Prospective Observational Study
Enrolling by invitation	`NCT05577273` - Does Antibiotic Prophylaxis at Urinary Catheter Removal Prevent Urinary Tract Infections	N/A