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
University of South Florida
60 participants
Oct 9, 2019
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria2
- 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 Criteria10
- 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.
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Interventions
Intradetrusor onabotulinumtoxin A is administered cystoscopically with 100 unit dose given as either 5 or 20 injections in a single procedure based on the arm the participant is randomized into.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT04305743