Using antibiotics before bladder Botox injections
Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA Treatment of Overactive Bladder: a Randomized Controlled Trial
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 |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Atlantic Health System Academic / other |
| Locations | 1 site (Morristown, New Jersey) |
| Trial ID | NCT05519072 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 and older who are scheduled to undergo bladder Botox treatment.
Not a fit: Patients who are pregnant, breastfeeding, or have contraindications to Botox or antibiotics will not benefit from this study.
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 performed: Other studies have explored antibiotic use in similar contexts, but this specific approach to bladder Botox procedures is relatively novel.
Eligibility criteria
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 this trial is running
Morristown, New Jersey
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.