Antibiotic Usage for Overactive Bladder

N/A

Recruiting

Led By Justina Tam, MD

Research Sponsored by Benaroya Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14-30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether it's necessary to give patients antibiotics before a procedure to treat overactive bladder.

Who is the study for?

Adults over 18 with an overactive bladder (OAB) who haven't improved with first and second-line treatments can join. They must not show symptoms or test positive for a urinary tract infection (UTI) at the time of treatment. Pregnant or breastfeeding women, recent antibiotic users, and those treated with high doses of onabotulinumtoxinA are excluded.

What is being tested?

The study is testing if giving antibiotics before injecting onabotulinumtoxinA into the bladder helps prevent UTIs in OAB patients without current infections. Participants will either receive a prophylactic antibiotic or no antibiotic before the procedure, to see which approach is better.

What are the potential side effects?

Potential side effects include complications from taking antibiotics like diarrhea that could lead to severe conditions, increased drug resistance, skin allergies, and stomach issues. The injection may also cause UTIs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14-30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14-30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14-30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Urinary tract infection

Secondary study objectives

Percentage of subjective improvement in overactive bladder symptoms

Rate of adverse events including dysuria, gross hematuria, and urinary retention

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Prophylactic antibioticExperimental Treatment2 Interventions

These patients will receive the current standard of care, which is to receive a single dose of prophylactic antibiotics just prior to receiving intravesical injection of Onabotulinumtoxin A via cystoscopy. The specific prophylactic antibiotics will vary depending on patient's prior urine culture sensitivities and patient medication allergies/sensitivities and medical comorbidities.

Group II: No antibioticsExperimental Treatment2 Interventions

These patients will receive no prophylactic antibiotics prior to receiving intravesical injection of Onabotulinumtoxin A via cystoscopy.

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