NCT05519072 Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA
| NCT ID | NCT05519072 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Atlantic Health System |
| Condition | Antibiotic Prophylaxis |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2022-08-16 |
| Primary Completion | 2024-08-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 140 participants in total. It began in 2022-08-16 with a primary completion date of 2024-08-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to show that lack of antibiotic prophylaxis to those undergoing bladder Botox injections is not significantly inferior to administering prophylaxis. By proving this, the investigators aim to decrease antibiotic use in this setting to combat the growing issue of antibiotic resistance. Participants will be randomized to antibiotic or no treatment arm. Those randomized to the treatment arm will receive oral antibiotics for 2 days pre-treatment, on the treatment day, and 2 days post-treatment. Participants will return for a follow up appointment approximately 2 weeks after treatment to assess for urinary tract infection (UTI) symptoms. They will be called again at 6 weeks for follow up.
Eligibility 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
Contact & Investigator
Carolyn Botros, DO
PRINCIPAL INVESTIGATOR
Atlantic Health System
Frequently Asked Questions
Who can join the NCT05519072 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Antibiotic Prophylaxis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05519072 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05519072 currently recruiting?
Yes, NCT05519072 is actively recruiting participants. Contact the research team at anastasiya.holubyeva@atlantichealth.org for enrollment information.
Where is the NCT05519072 trial being conducted?
This trial is being conducted at Morristown, United States.
Who is sponsoring the NCT05519072 clinical trial?
NCT05519072 is sponsored by Atlantic Health System. The principal investigator is Carolyn Botros, DO at Atlantic Health System. The trial plans to enroll 140 participants.