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Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA

ConditionAntibiotic Prophylaxis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAtlantic Health System

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Female

Age ≥ 18

Patient undergoing bladder Botox treatment

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nitrofurantoin

    Drug

    For those randomized to the treatment arm, antibiotics will be prescribed at the discretion of the ordering physician. They will be prescribed only in oral form and in accordance with the patient's allergy profile.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Antibiotic armExperimental treatment 1 intervention
Group B: No treatment armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Urinary tract infections

Number of participants with urinary tract infections

Time frame
2 weeks post-procedure

Secondary outcomes

1

Urinary tract infections

Number of participants with urinary tract infections

Time frame
6 weeks post-procedure

Other outcomes

1

Urinary retention and adverse reactions

Number of participants with reactions to antibiotics and urinary retention

Time frame
6 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Atlantic Health System

Lead sponsor

Columbia University

Collaborator

Source ClinicalTrials.gov
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