Recruiting

OnabotulinumtoxinA with Antibiotics

Sponsor:

Atlantic Health System

Code:

NCT05519072

Conditions

Antibiotic Prophylaxis

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Nitrofurantoin

Study Details

Brief 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.

Conditions

Antibiotic Prophylaxis

Study ID

NCT05519072

Start date

Aug 16, 2022

Status verified date

Mar, 2024

Completion date

Aug 16, 2024

Anticipated

Primary completion date

Aug 16, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Antibiotic arm

Antibiotics will be administered for 2 days pre-treatment, on the treatment day, and 2 days post-treatment.

no intervention: No treatment arm

No antibiotics administered.

Interventions

Nitrofurantoin

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.

Primary outcome measure

  • Urinary tract infections [ Time Frame: 2 weeks post-procedure ]

Central Contacts and Locations

Central contacts

Anastasiya Holubyeva, MD

9739717267anastasiya.holubyeva@atlantichealth.org

Locations

Atlantic Health

Recruiting

Morristown, New Jersey, United States, 07962-1905

Contacts

Lyudmila Babaev

862-246-4973lyudmila.babaev@atlantichealth.org

More Information

Sponsor

Atlantic Health System

Last update posted

Mar 27, 2024

Last verified

Mar, 2024

Keywords

  • Antibiotics
  • Botox
  • OnabotulinumtoxinA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Atlantic Health System on 2024-03-27.