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Antibiotic

Antibiotic Prophylaxis for UTIs in Overactive Bladder

Phase 4

Recruiting

Led By Jordan Gisseman, MD

Research Sponsored by Walter Reed National Military Medical Center

Eligibility Criteria Checklist

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

Must have

Diagnosis of OAB or IC/BPS

Be older than 18 years old

Must not have

Contraindication to onabotulinumtoxinA (allergy, pregnancy, greater than 400 units of onabotulinumtoxinA received in the last 3 months)

Contraindication to nitrofurantoin (allergy, CrCl <30mL/minute)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 30 days after intradetrusor injection of onabotulinumtoxina

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

"This trial aims to determine the best way to prevent urinary tract infections (UTIs) in female patients with overactive bladder or bladder pain syndrome who are treated with onabotulinumtoxinA

Who is the study for?

This trial is for female patients aged 18 or older who visit the urogynecology and urology clinics at Walter Reed National Military Medical Center, have been diagnosed with overactive bladder (OAB) or interstitial cystitis/bladder pain syndrome (IC/BPS), and opt for Botox injections into the bladder. Participants must not currently have a UTI.

What is being tested?

The study aims to find out if taking one dose of Nitrofurantoin 100mg at the time of Botox injection into the bladder is as effective in preventing UTIs as taking it twice daily for three days starting from the procedure day. It's a non-blinded randomized controlled trial comparing these two antibiotic regimens.

What are the potential side effects?

Potential side effects may include issues related to antibiotic use such as stomach upset, diarrhea, and in some cases, allergic reactions. Long-term use can lead to increased resistance to antibiotics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with overactive bladder or interstitial cystitis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not allergic to, pregnant, or have had over 400 units of Botox in the last 3 months.

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I am allergic to nitrofurantoin or my kidney function is poor.

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I currently have a urinary tract infection.

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I have had 3 UTIs in the last year or 2 in the last 6 months.

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I am currently on antibiotics.

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I have a condition where my bladder doesn't function properly due to nerve damage.

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I am not having any additional surgeries that raise UTI risk or need different antibiotics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 30 days after intradetrusor injection of onabotulinumtoxina

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 30 days after intradetrusor injection of onabotulinumtoxina

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 days after intradetrusor injection of onabotulinumtoxina 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

Adverse effects

Urinary retention

Urinary tract infection symptoms

Side effects data

From 2019 Phase 4 trial • 164 Patients • NCT03287089

Medication Intolerance

100%

80%

60%

40%

20%

Study treatment Arm

Nitrofurantoin

Placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Single dose armExperimental Treatment1 Intervention

Subjects will be given a single dose of 100mg nitrofurantoin by mouth at the time of intradetrusor injection of 100u onabotulinumtoxinA

Group II: 3 day armActive Control1 Intervention

Subjects will be given a 3 day twice daily course of 100mg nitrofurantoin by mouth starting at the time of intradetrusor injection of 100u onabotulinumtoxinA

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nitrofurantoin 100 MG

2021

Completed Phase 4

~230

0 / 8Eligibility criteria met