RECRUITING

Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA

Description

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.

Study Overview

Study Details

Study overview

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.

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

Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA

Condition
Antibiotic Prophylaxis
Intervention / Treatment

-

Contacts and Locations

Morristown

Atlantic Health, Morristown, New Jersey, United States, 07962-1905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Atlantic Health System,

Carolyn Botros, DO, PRINCIPAL_INVESTIGATOR, Atlantic Health System

Study Record Dates

2024-08-16