Actively Recruiting
Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A
Led by University of South Florida · Updated on 2020-11-05
60
Participants Needed
2
Research Sites
85 weeks
Total Duration
On this page
Sponsors
U
University of South Florida
Lead Sponsor
M
Medstar Health Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Currently, in clinical practice there has been no standardization in the number of injections a single dose of intradetrusor onabotulinumtoxin A is administered in. Given the increasing use of this treatment modality, the aim of this study is to compare outcomes for patients given a 100 unit dose of onabotulinumtoxin A split into 5 as compared to 20 injections for the treatment of overactive bladder or urgency urinary incontinence refractory to medical treatment.
CONDITIONS
Official Title
Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women 63;18 years of age with diagnosis of urinary urgency, urinary frequency, urgency urinary incontinence, overactive bladder.
- Procedure scheduled in either the outpatient clinic or the operating room to be performed without use of sedation, general, or neuraxial anesthesia.
You will not qualify if you...
- Male gender.
- Women <18 years of age.
- Non-English speaking.
- Pregnancy (patient will self-report pregnancy).
- Symptoms of overactive bladder due to any known neurological reason (e.g. spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc.).
- Use of clean intermittent catheterization or indwelling catheter to manage urinary incontinence.
- History or current diagnosis of bladder cancer or other urothelial malignancy.
- Known allergy or sensitivity to any botulinum toxin preparation.
- Any medical condition that may increase risk with exposure to onabotulinumtoxin A, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis.
- Scheduled for administration of onabotulinumtoxin A with use of sedation, general, or neuraxial anesthesia.
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Trial Site Locations
Total: 2 locations
1
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
2
University of South Florida Health South Tampa Center for Advanced Healthcare
Tampa, Florida, United States, 33606
Actively Recruiting
Research Team
E
Eric S Chang, MD
CONTACT
A
Allison Wyman, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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