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Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A
Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A for Treatment of Overactive Bladder: a Multi-center Randomized Controlled Trial
Who can join
Ages 18 and older · Women
Full eligibility criteria
Inclusion Criteria: * Women \>=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. Exclusion Criteria: * Male gender. * Women \<18 years of age. * Non-English speaking. * Pregnancy (patient will self-report pregnancy). * Participant has 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.) * Participant uses clean intermittent catheterization or indwelling catheter to manage urinary incontinence. * Participant has a history or current diagnosis of bladder cancer or other urothelial malignancy. * Participant has a known allergy or sensitivity to any botulinum toxin preparation. * Participant has any medical condition that may put her at increased risk with exposure to onabotulinumtoxin A, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis. * Participant is scheduled for administration of onabotulinumtoxin A with use of sedation, general, or neuraxial anesthesia.
About the study
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.
What is being tested
- OnabotulinumtoxinA 100 UNT (drug)
Sponsor: University of South Florida · Participants: 60 · Started: Oct 9, 2019
Contact the study team
- Eric S Chang, MD · Phone: 813-259-8500
- Allison Wyman, MD · Phone: 813-259-8500
Official record on ClinicalTrials.gov — NCT04305743
Locations in the U.S.
| District of Columbia | MedStar Washington Hospital Center, Washington D.C. |
| Florida | University of South Florida Health South Tampa Center for Advanced Healthcare, Tampa |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.