Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID04754737

Optimizing Antibiotic Use in Treatment of Overactive Bladder: Evaluating the Need for Prophylactic Antibiotics Prior to OnabotulinumtoxinA Injection in Patients Without Urinary Tract Infection

Led by Benaroya Research Institute · Updated on 2024-05-24

200

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

B

Benaroya Research Institute

Lead Sponsor

S

Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of prophylactic antibiotics before intradetrusor injection of onabotulinumtoxinA in patients with overactive bladder (OAB) who are not showing symptoms of urinary tract infection (UTI). This treatment is FDA approved and used when behavioral and oral medication therapies have not controlled OAB symptoms. Since UTIs are a common side effect of this injection and antibiotics are commonly given beforehand, this study aims to determine if antibiotics are necessary for patients without UTI symptoms and with negative urinalysis, addressing concerns about antibiotic overuse and resistance. The study compares two groups: one receiving a single dose of prophylactic antibiotics before the injection, which is the current standard of care, and another receiving no antibiotics prior to the cystoscopic injection of onabotulinumtoxinA. The choice of antibiotic depends on prior urine culture results, allergies, and medical conditions. The trial is randomized and monitors patients for differences in post-procedure symptomatic UTI rates. Participants will be assessed for symptomatic UTI within 14 days after the injection. Secondary measures include improvements in OAB symptoms and rates of side effects like painful urination, bloody urine, and urinary retention over 14 to 30 days. The study involves urine tests, symptom questionnaires, and monitoring for adverse events. The total duration of participation is based on follow-up visits within the first month after treatment to evaluate safety and treatment outcomes.

CONDITIONS

Brief Title

Antibiotic Usage Prior to OnabotulinumtoxinA Injection

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of overactive bladder with failure of first and second line therapies including bladder training, dietary modification, and pharmacotherapy with an anticholinergic and/or beta-3 agonist
  • Not symptomatic for urinary tract infection at the time of injection
  • Negative urinalysis at the time of injection defined as negative for nitrites and leukocyte esterase, with urine white blood cell count less than 5 per high-power field
  • Consent to participate in the study
Not Eligible

You will not qualify if you...

  • Antibiotic usage within 48 hours prior to intradetrusor onabotulinumtoxinA injection
  • Women who are pregnant or planning to become pregnant
  • Women who are breastfeeding
  • Concurrent use of onabotulinumtoxinA injection exceeding a maximum cumulative dose of 400 units in a 3-month interval

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 day

Participants receive a cystoscopic injection of onabotulinumtoxinA. They are randomly assigned to either receive a single dose of prophylactic antibiotic prior to the injection or no antibiotic before the procedure.

1 treatment visit (in-person)

Follow-up

Duration - 14 to 30 days

Participants are monitored for symptomatic urinary tract infection and other adverse events such as dysuria, gross hematuria, and urinary retention following treatment.

Approximately 2 follow-up visits (in-person or remote)

Trial Site Locations

Total: 1 location

1

Stony Brook Medicine

Stony Brook, New York, United States, 11794

Actively Recruiting

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Research Team

J

Justina Tam, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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