BridgeMD
ANTIBIOBONTA - Assessment of the interest of a peri-operative antibiotic strategy applied to patients with asymptomatic bacteriuria undergoing intra-vesical botulinum toxin A injections
EU CTIS ID: 2024-515107-19-00
What this study is testing
To demonstrate the non-inferiority of “antibiotic sparing strategy” compared to “peri-operative antibiotic strategy” (current recommendations) for occurrence of symptomatic UTI after intra-vesical BoNTA injection in the management of asymptomatic bacteriuria (AB) among MS and SCI patients undergoing CISC.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Female and male over 18 years-old
- Multiple Sclerosis or Spinal Cord Injury (traumatic or non-traumatic)
- Clean Intermittent Self-Catheterization as the exclusive bladder management
- Refractory Detrusor Overactivity leading to urinary incontinence (failure, intolerance or contra-indication to anti-muscarinic therapy)
- Treated with intra-vesical BoNTA injections having proved efficacy
- Asymptomatic Bacteriuria (bacteriuria threshold ≥ 10² CFU/mL) on pre-operative urine analysis (performed 5 days (+/- 2 days) before intra-vesical BoNTA injections)
You likely can't join if
- Contra-Indication to botulinum toxin a, and excipients included in study drugs
- Ongoing cyclic antibiotic therapy
- Ongoing corticosteroid therapy
- Modification of immunosuppressive or immunomodulatory therapy in the 3 months before inclusion
- Antibiotic therapy in the month before inclusion
- Absence of use of any recognized contraceptive method (e.g. hormonal, barrier, IUD, sterilization) or of consistent sexual abstinence
See the full eligibility criteria
- Female and male over 18 years-old
- Multiple Sclerosis or Spinal Cord Injury (traumatic or non-traumatic)
- Clean Intermittent Self-Catheterization as the exclusive bladder management
- Refractory Detrusor Overactivity leading to urinary incontinence (failure, intolerance or contra-indication to anti-muscarinic therapy)
- Treated with intra-vesical BoNTA injections having proved efficacy
- Asymptomatic Bacteriuria (bacteriuria threshold ≥ 10² CFU/mL) on pre-operative urine analysis (performed 5 days (+/- 2 days) before intra-vesical BoNTA injections)
- With a personal and functional e-mail address, a quasi-permanent Internet connection and a mobile phone.
- Contra-Indication to botulinum toxin a, and excipients included in study drugs
- Ongoing cyclic antibiotic therapy
- Ongoing corticosteroid therapy
- Modification of immunosuppressive or immunomodulatory therapy in the 3 months before inclusion
- Antibiotic therapy in the month before inclusion
- Absence of use of any recognized contraceptive method (e.g. hormonal, barrier, IUD, sterilization) or of consistent sexual abstinence
- 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
- Patient without easy access to internet within 6 weeks of the injection
- 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
- Having already participated to the study
- Augmentation cystoplasty
- Bladder compliance disorders (<20 mL/cmH2O)
- Morphologic urinary tract abnormalities considered as a risk factor for recurrent symptomatic UTI
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.