Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA

Part of paid clinical trials in Morristown, New Jersey.

Sponsor
Atlantic Health System
Study ID
NCT05519072
Phase
PHASE4
Status
Recruiting
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Conditions

  • Antibiotic Prophylaxis

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Nitrofurantoin — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 16, 2022
Status verified
Mar 2024
Primary completion
Aug 16, 2024
Completion
Aug 16, 2024

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Atlantic HealthMorristownNew Jersey07962-1905
Lyudmila Babaev
[email protected]
862-246-4973

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By research site
Atlantic Health· Morristown, NJ

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