RecruitingPhase 4NCT05519072

Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA

Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA Treatment of Overactive Bladder: a Randomized Controlled Trial


Sponsor

Atlantic Health System

Enrollment

140 participants

Start Date

Aug 16, 2022

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria3

  • Female
  • Age ≥ 18
  • Patient undergoing bladder Botox treatment

Exclusion Criteria4

  • 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

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Interventions

DRUGNitrofurantoin

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.


Locations(1)

Atlantic Health

Morristown, New Jersey, United States

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NCT05519072


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