RECRUITING

Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-08-16
Study Completion:2024-08-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05519072

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female
  2. * Age ≥ 18
  3. * Patient undergoing bladder Botox treatment
  1. * Pregnant and/or breastfeeding
  2. * 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.
  3. * Contraindication to oral antibiotics - hypersensitivity or allergy
  4. * Inability to take medication by mouth

Contacts and Locations

Study Contact

Anastasiya Holubyeva, MD
CONTACT
9739717267
anastasiya.holubyeva@atlantichealth.org

Principal Investigator

Carolyn Botros, DO
PRINCIPAL_INVESTIGATOR
Atlantic Health System

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Atlantic Health System

  • Carolyn Botros, DO, PRINCIPAL_INVESTIGATOR, Atlantic Health System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-16
Study Completion Date2024-08-16

Study Record Updates

Study Start Date2022-08-16
Study Completion Date2024-08-16

Terms related to this study

Keywords Provided by Researchers

  • Antibiotics
  • Botox
  • OnabotulinumtoxinA

Additional Relevant MeSH Terms

  • Antibiotic Prophylaxis