Skip to content
Bored Studies
RecruitingAccepts healthy volunteersPhase 4

Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA

Atlantic Health System · with Columbia University · NCT05519072

View Study & Apply (opens in a new tab)

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · Women only
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
140
US sites recruiting
1
Study start
August 16, 2022
Record last updated
March 27, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Nitrofurantoin

Conditions: Antibiotic Prophylaxis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Atlantic Health

    Morristown, NJ 07962-1905

    Site contact: Lyudmila Babaev · 862-246-4973 · lyudmila.babaev@atlantichealth.org

Study contacts (from the official record)

  • Anastasiya Holubyeva, MD · 9739717267 · anastasiya.holubyeva@atlantichealth.org
All healthy volunteers studies in New Jersey →
Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA (NCT05519072) | Bored Studies