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Search / Trial NCT05519072

Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA

Launched by ATLANTIC HEALTH SYSTEM · Aug 25, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Antibiotics Botox Onabotulinumtoxin A

ClinConnect Summary

This clinical trial is studying whether giving antibiotics before bladder Botox injections is necessary. The researchers want to find out if not using antibiotics leads to a similar rate of urinary tract infections (UTIs) compared to using them. By proving that antibiotics may not be needed, the study aims to help reduce the overall use of antibiotics, which is important for preventing antibiotic resistance—a situation where germs become harder to treat.

To participate in this trial, you need to be a female aged 18 or older who is planning to receive bladder Botox treatment. If you join, you will be randomly assigned to receive either antibiotics for a few days before and after the procedure or no antibiotics at all. After the treatment, you'll have a follow-up appointment about two weeks later to check for any UTI symptoms, and you'll receive a phone call at six weeks for an additional check-in. This study is currently looking for participants, and your involvement could help improve how bladder Botox treatments are managed in the future.

Gender

FEMALE

Eligibility 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

About Atlantic Health System

Atlantic Health System is a leading nonprofit health care organization dedicated to advancing medical research and improving patient outcomes through innovative clinical trials. With a commitment to excellence in patient care, Atlantic Health System integrates cutting-edge research into its comprehensive healthcare services, offering a wide range of clinical trials across various specialties. The organization fosters collaboration among multidisciplinary teams of physicians, researchers, and healthcare professionals to explore new treatments and therapies, ultimately enhancing the quality of life for patients in the communities it serves. Through its robust clinical research program, Atlantic Health System aims to contribute to the advancement of medical knowledge and the development of effective healthcare solutions.

Locations

Morristown, New Jersey, United States

Patients applied

0 patients applied

Trial Officials

Carolyn Botros, DO

Principal Investigator

Atlantic Health System

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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