The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society.
Paul Abrams, Linda Cardozo, Magnus Fall...
https://pubmed.ncbi.nlm.nih.gov/12559262Actively Recruiting
Phase 4
Age: 18Years +
All Genders
Healthy Volunteers
ID06387329
Urinary Tract Infection Prevention Using Nitrofurantoin in Bladder Botox Procedures: A Randomized Controlled Trial
Led by Walter Reed National Military Medical Center · Updated on 2025-02-19
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Overactive bladder (OAB) and bladder pain syndrome (IC/BPS) are common conditions that impact quality of life, affecting about 17% of people. This research evaluates different antibiotic plans to prevent urinary tract infections (UTIs) after intradetrusor onabotulinumtoxinA injections, a treatment for OAB and IC/BPS. The study aims to find the best timing, duration, and type of antibiotic to reduce UTIs and limit unnecessary antibiotic use that can cause side effects and resistance. Participants will be randomly assigned to one of two groups: one group will take a 3-day course of nitrofurantoin twice daily starting at the procedure time, and the other will take a single nitrofurantoin dose at the procedure time. Before the procedure, patients will have urine tests to ensure no current infection. On the day of treatment, patients will receive lidocaine and possibly diazepam for comfort, along with phenazopyridine and nitrofurantoin before the injection. The procedure follows standard medical guidelines. During the study, urine tests will be done if symptoms of UTI appear, and patients will be followed up 30 to 45 days after the procedure via phone, email, or messaging to check for UTIs and other outcomes. The main measure is the rate of UTIs within 30 days after the injection. Additional safety and symptom data will also be collected to evaluate the treatments. Participation will last through this follow-up period to monitor results.
CONDITIONS
Brief Title
Bladder Botox UTI Antibiotic Prophylaxis
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older seen at the WRNMMC Urogynecology clinic
- Diagnosis of overactive bladder or interstitial cystitis/bladder pain syndrome
- Planning to have intradetrusor onabotulinumtoxinA injection for treatment
- Ability to follow instructions and complete follow-up
You will not qualify if you...
- Allergy to nitrofurantoin or kidney function less than 30 mL/minute
- Concurrent surgery during procedure that increases UTI risk or requires different antibiotics
- Active urinary tract infection at time of procedure
- Neurogenic bladder condition
- History of recurrent urinary tract infections (3 in 12 months or 2 in 6 months)
- Post void residual bladder volume of 150 mL or more
- Currently taking antibiotics at time of procedure
- Allergy to onabotulinumtoxinA, pregnancy, or received more than 400 units of onabotulinumtoxinA in last 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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 - Up to 3 days
Participants receive intradetrusor onabotulinumtoxinA injection and take nitrofurantoin antibiotic prophylaxis either as a single dose or a 3-day course starting at the time of the procedure.
1 procedure visit with medication administration
Follow-up
Duration - 30 days
Participants are monitored for urinary tract infections and other adverse effects within 30 days after the procedure.
Visits as needed for symptom assessment and safety monitoring
Trial Site Locations
Total: 1 location
1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20899
Actively Recruiting
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Research Team
J
Jordan Gisseman, 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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Economic costs of overactive bladder in the United States.
Michael L Ganz, Amy M Smalarz, Tracey L Krupski...
https://pubmed.ncbi.nlm.nih.gov/20035977The Burden of Overactive Bladder on US Public Health.
W Stuart Reynolds, Jay Fowke, Roger Dmochowski
https://pubmed.ncbi.nlm.nih.gov/27057265Economic burden of urgency urinary incontinence in the United States: a systematic review.
Karin S Coyne, Alan Wein, Sean Nicholson...
https://pubmed.ncbi.nlm.nih.gov/24456314Global prevalence and economic burden of urgency urinary incontinence: a systematic review.
Ian Milsom, Karin S Coyne, Sean Nicholson...
https://pubmed.ncbi.nlm.nih.gov/24007713Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline.
E Ann Gormley, Deborah J Lightner, Kathryn L Burgio...
https://pubmed.ncbi.nlm.nih.gov/23098785Efficacy and safety of onabotulinumtoxinA for idiopathic overactive bladder: a double-blind, placebo controlled, randomized, dose ranging trial.
Roger Dmochowski, Christopher Chapple, Victor W Nitti...
https://pubmed.ncbi.nlm.nih.gov/20952013Outcome of a randomized, double-blind, placebo controlled trial of botulinum A toxin for refractory overactive bladder.
Michael K Flynn, Cindy L Amundsen, MaryAnn Perevich...
https://pubmed.ncbi.nlm.nih.gov/19375091Efficacy of botulinum toxin-A for treating idiopathic detrusor overactivity: results from a single center, randomized, double-blind, placebo controlled trial.
Arun Sahai, Mohammad Shamim Khan, Prokar Dasgupta
https://pubmed.ncbi.nlm.nih.gov/17509328Botulinum A toxin injections into the detrusor: an effective treatment in idiopathic and neurogenic detrusor overactivity?
Thomas M Kessler, Hansjörg Danuser, Martin Schumacher...
https://pubmed.ncbi.nlm.nih.gov/15747344