Using antibiotics before bladder Botox injections
Official title: Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA Treatment of Overactive Bladder: a Randomized Controlled Trial
Run by Atlantic Health System · NCT05519072 · Data updated 2026-11-12
This study tests if skipping antibiotics before bladder Botox injections is just as safe as using them for people getting the procedure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 140 (estimated) |
| Sponsor | Atlantic Health System Academic / other |
| Locations | 1 site (Morristown, New Jersey) |
| Status | Recruiting |
| Started | August 16, 2022 |
| Main results expected | August 16, 2024 |
| Study ends | August 16, 2024 |
| Registry record updated | March 27, 2024 |
| Trial ID | NCT05519072 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are females aged 18 and older who are scheduled to undergo bladder Botox treatment.
✕Probably not a fit
Patients who are pregnant, breastfeeding, or have contraindications to Botox or antibiotics will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates whether not using antibiotic prophylaxis before bladder Botox injections is as safe as using antibiotics. Participants will be randomly assigned to receive either antibiotics or no treatment prior to their Botox procedure. The study aims to reduce unnecessary antibiotic use, addressing the issue of antibiotic resistance, while monitoring for urinary tract infections and other related complications. Follow-up assessments will occur two weeks and six weeks post-treatment to evaluate outcomes.
Why it matters
Potential benefit: If successful, this study could lead to reduced antibiotic use in bladder Botox procedures, minimizing the risk of antibiotic resistance.
How similar studies have gone: Other studies have explored antibiotic use in similar contexts, but this specific approach to bladder Botox procedures is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * Age ≥ 18 * Patient undergoing bladder Botox treatment Exclusion Criteria: * Pregnant and/or breastfeeding * Contraindication to injection of Botox - hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, symptomatic urinary retention or post void residual (PVR) \> 200 mL, unwillingness or inability to initiate clean intermittent catheterization (CIC) post-treatment if required. * Contraindication to oral antibiotics - hypersensitivity or allergy * Inability to take medication by mouth
Where it's running
-
Atlantic Health
Morristown, New Jersey, United States Recruiting
Study contacts
- Principal investigator: Carolyn Botros, DO — Atlantic Health System
- Study coordinator: Anastasiya Holubyeva, MD
- Email: anastasiya.holubyeva@atlantichealth.org
- Phone: 9739717267
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Which single-dose antibiotic works best to prevent complications after lower wisdom tooth removal
This trial tests whether a single dose of amoxicillin, clindamycin, or azithromycin is best at reducing post-surgery problems for adults undergoing lower wisdom tooth extraction.
-
Piperacillin Prophylaxis in Major Liver and Pancreatic Surgery
This study tests whether piperacillin/tazobactam given around surgery reliably reaches the right levels to help prevent infections in adults undergoing major liver or pancreatic surgery.
-
Antibiotic Prophylaxis Before Simple Tooth Extraction in Immunosuppressed Patients with Autoimmune Rheumatic Diseases
This trial tests whether giving a single dose of amoxicillin before a simple tooth extraction can prevent infections in adults with autoimmune rheumatic diseases who are on immunosuppressive therapy.
-
Adding azithromycin to ampicillin for late PPROM
This test sees if adding a single dose of azithromycin to the usual ampicillin/amoxicillin treatment helps newborns when membranes break early between 34.0 and 36.6 weeks.
-
Cefazolin Prophylaxis and CSF Levels in Ventricular Shunt Surgery
This study tests whether a standard 2 g dose of cefazolin given before ventricular shunt surgery yields enough drug in the brain’s fluid to help prevent valve infections.
-
Understanding antibiotic resistance and microbiome changes in STI prevention
This study is trying to see how using doxycycline for STI prevention affects antibiotic resistance and changes in gut bacteria in men who have sex with men.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.