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Preventing UTIs After Bladder Botox for OAB or IC/BPS

This study is looking at whether a specific antibiotic, Nitrofurantoin 100 MG, can help prevent urinary tract infections (UTIs) in people who are getting Botox (onabotulinumtoxinA) injections into their bladder. These injections are used to treat overactive bladder (OAB) or interstitial cystitis/bladder pain syndrome (IC/BPS). UTIs are a common side effect after these injections. The study will measure how many people get a UTI within 30 days after their Botox injection. You may be able to join if you are 18 or older, have OAB or IC/BPS, are planning to get bladder Botox, and can follow instructions. The study aims to enroll 100 participants.

Study design
This interventional study plans to enroll 100 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure urinary tract infection within 30 days after their injection.

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NCT06387329

Bladder Botox UTI Antibiotic Prophylaxis

Recruiting
PHASE4Ages 18+InterventionalPrevention
Walter Reed National Military Medical Center
~100 participants
Updated 2025-02-19 on ClinicalTrials.gov
What's tested:Nitrofurantoin 100 MG

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Urinary tract infection
Measured over Within 30 days after intradetrusor injection of onabotulinumtoxinA

Conditions

Overactive Bladder
Bladder Pain Syndrome

Explore related trials

Chronic primary bladder pain syndromeOveractive Bladder

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Jordan Gisseman, MD · PRINCIPAL_INVESTIGATOR · Walter Reed National Military Medical Center

Who to contact

Jordan Gisseman, MD
[email protected]
301-400-2468
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

All patients 18 years or older being seen at the WRNMMC Urogynecology clinic
Diagnosis of OAB or IC/BPS
Planning to undergo intradetrusor onabotulinumtoxinA injection for treatment of their OAB or IC/BPS
Ability to follow instructions and complete follow up

Exclusion

Contraindication to nitrofurantoin (allergy, CrCl \<30mL/minute)
If performed in the operating room, the patient cannot undergo a concurrent procedure that would increase the risk of UTI or require an alternate antibiotic regimen (such as hysterectomy, prolapse repair, or anti-incontinence procedure)
Active UTI at the time of procedure
Neurogenic bladder
Recurrent UTI (3 in 12 month period or 2 in 6 months)
Post void residual bladder volume ≥150mL
Patient is already taking antibiotics at the time of the procedure
Contraindication to onabotulinumtoxinA (allergy, pregnancy, greater than 400 units of onabotulinumtoxinA received in the last 3 months)

What this trial measures

  • Urinary tract infectionWithin 30 days after intradetrusor injection of onabotulinumtoxinA

    To evaluate for non-inferiority in the number of post-procedure urinary tract infections proven by a urine culture