Actively Recruiting
Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA Treatment of Overactive Bladder
Led by Walter Reed National Military Medical Center · Updated on 2020-04-28
184
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
OnabotulinumtoxinA is an effective treatment for both idiopathic and neurogenic overactive bladder and was FDA approved for this indication in 2013. The standard technique for injecting onabotulinumtoxinA into the detrusor is mixing 100 units of onabotulinumtoxinA into 10mL of injectable normal saline and injecting 20 sites with 0.5mL in the posterior wall of hte bladder for idiopathic overactive bladder and mixing 200 units into 30mL and injecting 30 sites with 1mL for neurogenic overactive bladder. The purpose of this study is to compare the efficacy of a technique using a reduced number of injections with the same dosage of onabotulinumtoxinA to the standard technique. The hypothesis is that the reduced technique will not be inferior in terms of efficacy as the standard technique and that there will be a lower incidence of urinary tract infections and urinary retention requiring catheterization post-procedure.
CONDITIONS
Official Title
Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA Treatment of Overactive Bladder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Main symptoms include urinary urgency, frequency, or urge incontinence
- Failed or declined at least one medication or behavioral treatment for overactive bladder
- Willing to perform self-catheterization if urinary retention occurs
- Able to follow study instructions and complete all required follow-ups
You will not qualify if you...
- Currently using oral medications for overactive bladder (anticholinergics or beta 3 agonists)
- Post-void residual urine volume greater than 200 ml
- Untreated symptomatic pelvic organ prolapse stage 2 or higher
- Active urinary tract infection
- Use of intradetrusor botulinum toxin within the last 6 months
- Use of 400 units or more of botulinum toxin in other body areas in the last 3 months
- Procedure scheduled in a main operating room instead of outpatient setting
- Diagnosis of interstitial cystitis or painful bladder syndrome
- Female who is pregnant, planning pregnancy, thinks they may be pregnant, or cannot use reliable contraception
- Medical conditions increasing risk with botulinum toxin such as myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, neuropathy, or kidney stones
- Known allergy or sensitivity to onabotulinumtoxinA components
- Participation in another investigational drug or device study that could affect results
- Any condition or situation that may increase risk, interfere with study results, or participation, as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Actively Recruiting
Research Team
A
Angela DiCarlo-Meacham, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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